NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Tuesday, 30 December 2008

The FDA has approved Ferring Pharmaceuticals' degarelix which is manufactured by Rentschler Biotechnologie

FDA

Jubilant Organosys will buy back $253m foreign currency convertible bonds

Business Standard

FDA approvals up in 2008

The FDA will approve 21 drugs in 2008, up from 18 last year. However, the agency has missed its targets for 15 other products.
Washington Post

Dow-Rohm & Haas merger under threat

The $15.4bn merger between Dow Chemical and Rohm & Haas is under threat following the collapse of Dow's deal with Kuwait. Shares in both companies dropped.
Bloomberg

Dishman breaks ground for SEZ, plans JVs

Dishman has broken ground for its Pharma, Fine Chemicals and Engineering Special Economic Zone (SEZ) on a 300 acre site near Bavla-Bagodara. The $205m investment is due to be operational in 2010 and is expected to provide employment to 50,000 people. Dishman plans to use 40% of the site in joint manufacturing ventures with global pharma companies.
Desh Gujarat
Economic Times

CMC Biologics delays expansion

CMC Biologics has postponed its previously announced plans to expand its Bothwell manufacturing facility.
In-Pharma Technologist

Albemarle aims for $40m savings

In response to falling demand, Albemarle is planning a series of measures to achieve $40m in annualised cost savings in 2009. The company plans to achieve the savings by accelerating its cost reduction programs and resizing its business footprint.
Forbes

Dishman changes financing plans

Dishman Pharmaceuticals has failed to raise $30m from the World Bank’s International Finance Corporation. The company will now use non-convertible bonds to fund its aggressive expansion plans.
Economic Times

Thursday, 18 December 2008

FDA Commissioner von Eschenbach will retire on inauguration day

Wall Street Journal

Good year for Ampac, sees future growth

American Pacific's Ampac Fine Chemicals business saw revenues increase 19% to $124.2m in the year ended 30 September 2008 primarily driven by increased volume for anti-viral products. The company sees a decline in demand in 2009 but believes the pharmaceutical fine chemicals market will continue to present growth opportunities in the longer term as the pharmaceutical industry continues to outsource. Ampac expects to meet its growth in the segment through strategic acquisitions and to a lesser extent investment in our facilities.
American Pacific

Cefic groups welcome API inspection programme

Cefic's European Fine Chemicals Group and Active Pharmaceutical Ingredients Committee have welcomes the establishment of an International Cooperative API Inspection Programme. The programme is designed to coordinate inspection resources from Europe, USA, and Australia in higher risk countries - especially in Asia - and aims to prevent counterfeit APIs reaching patients.
EFCG

ReceptoPharm will produce clinical trial materials for Celtic Pharma's CB-24

Outsourcing Pharma

Thursday, 11 December 2008

Hovione buys Pfizer plant

Hovione has acquired Pfizer's Loughbeg, Ireland, API manufacturing facility. Following the deal is due to be completed by April 2009, Hovione will provide manufacturing for Pfizer. The facility will employ 70-80 staff - a reduction of about 150 on current levels. Over the next two years Hovione will transfer products from its Loures, Portugal site and validating processes for new compounds in expectation of drug approval.
RTE

BASF has opened an applications laboratory for pharmaceutical excipients and APIs in Mumbai, India

BASF

Actavis' Bulgarian MBO

Actavis will sell its Razgrad, Bulgaria, production company to the management. The facility will then be used for contract manufacturing generic APIs.
In-pharma Technologist

Chemists at the University of Bristol have developed a method of producing enantiomers of chiral tertiary alcohols

Chemical & Engineering News

Dow cuts back

Mirroring the recent actions by BASF and DuPont, Dow Chemical is to close 20 plants and idle 180 more. In addition the company will make 5000 redundancies, some of which will come through sell-offs.
Bloomberg

Synthetech saw revenues rise and losses decrease in its 2009 Q1

PR Newswire

Sun Pharmaceutical Industries has acquired API manufacturer Chattem Chemicals

Financial Express

Pharmaterials will commence manufacture of products for Phase I trials in 2009

Outsourcing-Pharma

WuXi PharmaTech will discontinue biologics manufacturing at its Philadelphia facility

Outsourcing-Pharma

Thursday, 4 December 2008

BASF a step closer to finalising Ciba acquisition

BASF

DSM wins NicOx deal, Archimica loses out

NicOx has selected DSM to manufacture the API for its potential blockbuster, Naproxcinod, which has completed its phase III trials. The API will be produced in DSM's Linz, Austria, facility. As a result of the agreement with DSM, NicOx has ended its API supply agreement with Archimica.
Reuters

Monday, 1 December 2008

Management buy-out for Seal Sands site

The Evonik fine chemicals custom manufacturing site at Seal Sands, UK, has been acquired by the site’s management. In future the site will operate as an independent limited company - Fine Organics - and will continue to manufacture products for Evonik.
The Chemical Engineer

Lonza does not expect its operating profit growth this year and next to match targets through 2013

Bloomberg

Thursday, 27 November 2008

Calls for FDA overhaul

In the run up to the change of President in the US, former FDA officials, members of Congress, watchdog groups and various government reports are suggesting the Agency requires an infusion of strong leadership, money, technology and personnel, and perhaps a major restructuring.
Washington Post

Profit rise at Matthey

Johnson Matthey's Fine Chemicals & Catalysts Division’s saw its operating profit rise 5% to £32.4m. The Macfarlan Smith API and intermediate business achieved good sales growth in specialist opiates, despite a rise in manufacturing costs. The Pharmaceutical Materials and Services API manufacturing business had reduced income from amphetamine salts.
Johnson Matthey

RFCL-Mallinckrodt Baker deal delayed because of valuation problems

Indian Stock Daily

Three contracts for Eden

Eden Biodesign has signed three contracts worth a total of £2.97m for development and cGMP manufacturing services. Two of the contracts are with new clients, one in Asia and one in Europe, the other is for a new therapeutic with an existing UK client.
Eden Biodesign

Gedeon Richter has licensed DSM Biologics and Crucell's PER.C6 biopharmaceutical production platform

Crucell

Dishman Pharma thinks it could see a 30% growth in revenues in its 2008-2009 year

Business Standard

PacificGMP will manufacture Actinium's HuM195 monoclonal antibody for a Phase I/II clinical trial

Pacific GMP

BASF to idle 80 plants reduce production in 100 more

BASF

Wednesday, 19 November 2008

FDA opens China office

The FDA has opened its first overseas office - in Beijing, China - as part of its strategy to ensure the safety of drugs and food products imported into the US. The FDA will also open offices in Shanghai and Guangzhou in China as well as in India, Latin America and Europe. The FDA will have eight staff in its China offices. These will include inspectors and senior technical experts on regulation, policy, food, medicines and medical devices who will work with their Chinese counterparts to build capacity and offer their experiences and expertise.
Associated Press

Deretil in management buy-out

The management of DSM Deretil has reached an agreement with DSM for a management buy-out of the business. Deretil will continue to focus on its core business of producing side-chains for API manufacturing. FInancial details of the buy-out have not been revealed.
DSM

Tuesday, 18 November 2008

Codexis licenses in enzyme technology

Codexis has licensed Dyadic International's C1 expression system for large-scale production of enzymes in fields including pharmaceutical intermediate production. Codexis will make a $10m upfront payment provided that certain performance criteria are satisfied.
Codexis

BioReliance will produce investigational quantities of Provecs Medical's Immunalon

Business Wire

Wacker Biotech has extended the licensing agreement with MorphoSys for its prokaryotic secretion technology for antibody manufacture

MorphoSys

Recipharm moves into biologics manufacturing

Recipharm's biotech subsidiary, Recipharm Biotech, has acquired AstraZeneca's biotech manufacturing facility in Södertälje, Sweden. AstraZeneca has entered a supply arrangement with Recipharm for Phase I and Phase II material for one of its development projects and will hold a significant minority stake in the new company.
Recipharm

BASF has acquired 94.55% of Ciba shares

BASF

Jubilant Organosys has acquired TrialStat ClinicalAnalytics for C$750,000

India Infoline

Thursday, 13 November 2008

Delays for Dishman

Dishman has slowed its plans to develop two special economic zones in Bavla. The company said the development could be delayed by six months. In addition the completion of construction of Dishman's manufacturing unit in China has been delayed has delayed until early next year. Dishman's oncology bulk drugs unit in Gujarat is expected to come on stream in the first quarter 2009.
Reuters

Thursday, 6 November 2008

Cambrex expects market softening

Cambrex saw a small increase in sales in the third quarter. Steven Klosk, Cambrex President and ceo, said "the market for early stage clinical development projects is softening. This is especially true of emerging biotech companies and our large pharma customers in Europe." Klosk attributed this to cost containment programs and a continuous review of R&D pipeline by big pharma and smaller companies focusing on fewer projects.
Cambrex is nearing completion of its new mid-scale API manufacturing facility at its Swedish operation, which is expected to be on line in early 2009. The company has started production in a portion of its state of the art API finishing facility in Milan, Italy, with the remainder in the later stages of validation. The new high potency development center in Charles City, Iowa, is also now fully operational. Klosk said these facilities position the company well for future growth.
Seeking Alpha

Lonza completes expansion

Lonza has completed the biologics manufacturing capacity expansion at its Portsmouth, NH, site. The $300m, 33,000m2 expansion brings reactor capacity at the site to 93,000L. Lonza wil also increase its workforce by more than 300 employees.
New Hampshire Union Leader

Thursday, 30 October 2008

Jubilant Organosys has strategically aligned its two North American businesses

Jubilant Organosys

Shasun to close Scottish plant

Shasun Chemicals & Drugs Ltd will close its Annan, Scotland, facility by March 2009. The facility, run by UK subsidiary Shasun Pharma Solutions Ltd, was acquired from Rhodia in 2006.
Financial Express

Wednesday, 29 October 2008

AMRI expands in India

Albany Molecular Research has expanded its Aurangabad, India, manufacturing facility with the addition of a 1000L non-GMP multipurpose pilot plant. The company said the plant will be used to produce starting materials and intermediates for its manufacturing facilities in the US and reduce the company’s reliance on third-party resource providers.
Albany Business Review

Albemarle's fine chemicals business saw a 24% increase in sales to a record $167.2m in Q3 2008

Albemarle

Biotech woes hit Lonza

The financing difficulties currently facing small and start-up biotech companies are hitting Lonza. The company warned it may miss its mid-term earnings target in 2008 and may not be able to offset weaker economic growth in the second half. The company expects the macroeconomic challenges to continue in 2009.
Reuters

Dishman takes loan

Dishman Pharmaceuticals and Chemicals Ltd is funding expansion projects through a loan from the International Finance Corp. Dishman will use the loan to build new facilities at its Bavla manufacturing site, invest around $10m to establish a manufacturing facility in Shanghai, China, and invest in overseas subsidiaries and joint ventures.
Sindh Today

DSM Pharma profit falls 37% following contract expirations

DSM

Piramal sees Indian growth

Nicholas Piramal's custom manufacturing business has seen strong growth, 11%, in the first half of its 2009 year. Revenues from its Indian facilities grew 55% to Rs1.5bn.
Nicholas Piramal

SAFC sees decline

SAFC Pharma, the fine chemicals business of Sigma-Aldrich saw a decline during Q3 as a result of spending cutbacks in the pharmaceutical sector. Kirk Richter, Sigma-Aldrich's Treasurer and Investor Relations executive, said that "customers have either deferred committed orders or not repeated the business we've enjoyed in the past". He did remain optimistic going forward.
Seeking Alpha

Borgas: Consolidation and closures required

Stefan Borgas, ceo of Lonza, believes that there is 60% overcapacity in pharmaceutical manufacturing for chemical ingredients with a highly fragmented industry. Borgas believes that some niche capabilities may offer protection, but ultimately there needs to be consolidation in the sector along with plant closures and modern, more efficient plants being built. He also warned that the biologics manufacturing sector could follow the same "sinful path" towards fragmentation and overcapacity.
In-Pharma Technologist

Thursday, 23 October 2008

FDA inspection rate is slow

The US Congress has revealed that FDA oversight of foreign plants producing pharmaceutical products for the US market leaves a lot to be desired. The investigation revealed that at current rates it will take 13 years to inspect the 3,249 plants currently providing products. The FDA takes about 2 years to inspect the 3,000 plants in the US.
Associated Press

Tuesday, 21 October 2008

FDA is missing drug review deadlines

Reuters

FDA outlines overseas plans

FDA Commissioner Andrew von Eschenbach has laid out further details of the Agency's plans to establish more overseas offices during the next year. The first of these will open in China before the end of 2008. The FDA plans to have 60 regulators world-wide over the next year, with a particular focus on India, Latin America and the Middle East in addition to China.
Wall Street Journal

Tuesday, 14 October 2008

North Carolina is targeting pharmaceutical and biopharmaceutical manufacturing companies to support a research campus

Business Journal

Country of origin labeling proposed

The US Senate is considering a bill that will require the country-of-origin of APIs and excipients to be labeled on finished prescription and OTC products. The bill is different from the proposal in the draft of the US FDA Globalization Act as it includes excipients.
In-Pharma Technologist

UC-Berkeley will open a Center for Biopharmaceutical Operations in 2009 to improve biologics manufacturing

East Bay Business Journal

QSV Biologics will carry out process development and cGMP manufacturing of a recombinant protein vaccine for NovaDigm Therapeutics

QSV Biologics

New funds for Reaxa

Reaxa has completed a rights issue underwritten by its institutional investors, EV and YFM Private Equity. Reaxa will use the funds for sales and marketing expansion and for commercial scale production of its scavenger and EnCat catalyst ranges.
Reaxa

Friday, 10 October 2008

Hovione launches trainee bursary programme

Hovione

EFIG launches excipients project

The European Fine Chemicals Group (EFCG) and IPEC Europe have formed a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe for manufacturers and distributors of pharmaceutical excipients. EFCG also welcomed recent announcements and actions taken by the regulatory authorities on both sides of the Atlantic and in Japan to stem the flow of sub-standard and counterfeit APIs and medicines in the wake of the heparin disaster earlier this year. Finally, EFCG set out its implementation plan for a worldwide "Voluntary Guidelines for ISO-regulated Fine Chemical Manufacturers", which is a proposed set of minimum requirements for global manufacturers of non-pharma fine chemical intermediates and active ingredients.
EFCG
EFCG
EFCG

SF-Chem has been renamed CABB AG

SF-Chem

Solvias has licensed asymmetric hydrogenation and C-X coupling ligands from Evonik

Solvias

Almac offers solid state services

Almac has added a Solid State Chemistry business to its pharmaceutical operations. Based in Craigavon, Northern Ireland, the team specialises in solid form characterisation, screening and selection, in addition to crystallization process development.
Almac

CPhI Innovation award winners

Novozymes Biopolymer won the Gold award at the 2008 CPhI Innovation Awards for its HyaCare hyaluronic acid process. Pierre Fabre Medicament won the silver award for its Formulplex "green" formulation process and Dr Reddy's precatalyst fabrication technology the bronze.
CPhI

Thursday, 9 October 2008

Evonik workers block separation of chemicals business

Bloomberg

Daiichi Sankyo-Ranbaxy deal gets government OK

Hindu Business Line

Jubilant Organosys has formed a drug development joint venture with Eli Lilly

Reuters

Ferro sells fine chems unit

Ferro Corporation has sold its fine chemicals business to Arsenal Capital Partners for $66m. Following the deal, which is expected to close by the end of the year, the business will be renames Novolyte Technologies.
RTT News

Wednesday, 1 October 2008

SAFC commissions HPAPI facility

SAFC Pharma has commissioned a high-potency API conjugates suite at its St Louis site to support oncology drug development. The suite will accommodate early-stage clinical supplies with the capability to expand production up to commercial-scale.
Pharmaceutical Online

Aptuit streamlines early stage drug development

Aptuit has launched a new programme to speed the early stages of drug discovery. Indigo aims to support development from discovery through to proof-of-concept and includes API manufacturing, toxicology, metabolism/pharmacokinetics, clinical supplies and regulatory application.
Aptuit

BASF introduces new hydrogenation catalysts

BASF

SAFC increases API capacity by 15%

SAFC Pharma has begun operation of a new reactor at its Arklow, Ireland, site. The 6000L reactor, which is part of a $4m project, increases SAFC's API production capacity by 15%. SAFC is also carrying out two further enhavcements in Arklow: a $2.25m pilot-scale filter dryer due for commission in Q32009; and a $1.8m expansion of warehouse capacity due for completion in 2009.
Sigma_Aldrich

Monday, 29 September 2008

CMC Biologics to expand capacity

CMC Biologics will expand capacity at its Bothell, WA, contract manufacturing facility five-fold as part of a $35m expansion plan. CMC expects the project to be completed by mid-2010.
Seattle Times

Bayer has teamed with Kentucky BioProcessing to advance the manufacture of drugs in tobacco plants

Loiusville Courier-Journal

DSM Biologics and Crucell have scaled up their high-titer fed-batch process for producing biologics using the PER.C6 system

Crucell

Piramal launches clinical trial supplies and acquires CRO

Piramal Healthcare has launched a clinical trials supply service from its Morpeth, UK, facility. The company has also acquired a Romanian clinical trials management company, Tangent Data s.r.l., which will be integrated into its contract manufacturing business.
Piramal Healthcare

Excelsyn upgrades Holywell

Excelsyn has added Fauske adiabatic and TSU calorimetry equipment at its Holywell, Wales, site and is now able to conduct stability testing in-house. Excelsyn has also added laboratory-scale hydrogenation capability. These additions are part of the recently completed initial phase of its three-year expansion and upgrade programme at Holywell.
Excelsyn

Novasep has added a cGMP pilot scale continuous chromatography unit at its Chasse sur Rhône, France, facility

Novasep

Wednesday, 24 September 2008

Pfizer to use sonocrystallisation

Pfizer will use Prosonix's Prosonitron reactor and sonocrystallisation technology in its API production at its manufacturing facilities in Ireland. Prosonix claims the technology allows the control of many aspects of complex pharmaceutical crystallisation processes, including control of crystal size, shape, and purity, the selective production of polymorphs, enhancing both manufacturing productivity and ultimate formulation performance of drug product.
In-Pharma Technologist

Aesica has established a US subsidiary

BioNity

Monday, 22 September 2008

Calyx Chemicals and Pharmaceuticals plans acquisition to broaden capabilities from API manufacturing to CRAMS

In-Pharma Technologist

RohnerChem to scale up EnCat

RohnerChem is to scale up Reaxa's EnCat technology. The companies have previously worked on initial screening and process development for the encapsulated catalysts.
In-Pharma Technologist

Clariant to sell businesses

Reuters

Wednesday, 17 September 2008

Pharmatek opens high potency facility

Pharmatek has opened its 1800m2 highly-potent and cytotoxic facility in San Diego. The new development includes analytical and formulation development laboratories and cGMP manufacturing suites.
Pharmatek

Ranbaxy products blocked by FDA after warning letters for two plants

In-Pharma Technologist

BASF offer rejected by large Ciba shareholder

Reuters

Tuesday, 16 September 2008

DSM-LibraGen amine technology deal

DSM and LibraGen will co-develop new omega-transaminases for production of chiral amines. LibraGen will use its enzyme discovery and development to identify enzymes to convert ketones to optically pure amines. DSM will produce the enzyme using its fermentation capabilities and PluGbug expression platform.
LibraGen

KPMG predicts Indian contract manufacturing market to reach $2.46bn/year by 2010

Live Mint

Significant growth in Excelsyn sales

Excelsyn saw like-for-like sales increase 43.5% to $28m for its year ended 31 May. The company attributed the growth to an acceleration in volume demand and customer numbers for its pharma synthesis business and continuing growth in outsourcing of development and manufacturing services. Excelsyn ceo Ian Shott said the company's strategy, introduced in January, was delivering a significant upturn in business.
Excelsyn

European Commission updates radiopharmaceutical GMP requirements

In-Pharma Technologist

BASF acquires Ciba for CHF6.1bn, further sector integration expected

Bloomberg
Financial Times

Thursday, 11 September 2008

Lonza expects more outsourcing, plans acquisitions

Lonza CFO Toralf Haag has said the company expects to benefit from the pharma industry's continuing trend towards more outsourcing. He also said the company has CHF1.5bn-2bn ($1.3bn-$1.8bn) available for acquisitions in the next year.
The Guardian

Tuesday, 9 September 2008

FDA revises cGMP guidelines

The FDA has amended its cGMP requirements for finished pharmaceuticals. This amendments concern aseptic processing, verification of performance of
operations by a second individual, and the use of asbestos filters. The FDA said it changes were to "modernise or clarify some of the requirements as well as to harmonize them with other FDA regulations and international cGMP standards". The amendments which are the first phase of an incremental approach to modifying the cGMP regulations will be effective from 8 December 2008.
FDA

Bayer shares rose on market rumours of takeover interest from Pfizer

Reuters

CVC Capital Partners has received approval from the EU for its acquisition of part of Evonik

Reuters

Sunday, 7 September 2008

SOCMA plans for "Last 100 days"

SOCMA intends to ensure that legislation key for the success for its members does not fall by the wayside during the last 100 days of the Bush Administration. SOCMA will be meeting regulatory agencies overseeing unfinished business to urge completion of its priority issues as well as ensuring that the McCain and Obama campaigns are aware of these issues.
SOCMA

Human Genome Sciences will use excess manufacturing capacity to produce biosimilar products for Hospira

Reuters

SAFC confirms HP-API expansion plans

Sigma-Aldrich has confirmed plans for a $30m expansion of its SAFC high potency API facility in Madison, Wisconsin. SAFC has purchased 15 acres of land in Verona, Wisconsin, for the 4500m2 facility, which will include development laboratories, a 150L mini-processing plant and two large-scale cGMP manufacturing suites with reactors up to 4000L. Construction is expected to be completed by end-2009.
In-Pharma Technologist

Dishman plans Carbogen Amcis IPO

both acquired by Solutia in 2000. Solutia rebranded the businesses as Solutia Pharmaceutical Services before formally merging them into a single legal entity: Carbogen Amcis in 2006. Dishman acquired Carbogen Amcis from Solutia in May 2006 and has made a number of investments in the business over the past two years.
Sify Business

Codexis withdraws IPO citing unfavourable market conditions

San Jose Business Journal

Sunday, 31 August 2008

Dishman builds Carbogen Amcis facility

Dishman is building the biggest oncology and high potency drugs facility in Asia at its Bavla plant. The Rs500m ($11m) facility is being commissioned by Dishman's Carbogen Amcis subsidiary, which will also operate the facility. In addition, Dishman Pharmaceuticals is investing Rs5bn ($115m) in two special economic zones near Bavla. The chemicals and pharmaceutical zone is expected to house 50 facilities and the engineering zone 100 facilities. Work on the zones will start before the end of the year.
Business Standard
Financial Express

Jubilant Organosys plans to expand its generic drugs capabilities from its Roorkee, India, plant

Economic Times

Wednesday, 27 August 2008

CNOOC to establish fine chemicals park

CNOOC, the China National Offshore Oil Corp, as part of its current strategy to expand beyond its traditional upstream businesses will construct a fine chemical industrial park in the Shenzen special economic zone bordering Hong Kong. CNOOC has signed a memorandum of understanding with the government of Shenzhen city to jointly develop the park.
Trading Markets

Tuesday, 26 August 2008

Aesica has opened its new global corporate headquarters in Newcastle-Upon-Tyne, UK

PharmaLive

Codexis expands Arch deal

Codexis has expanded its three-yeas strategic collaboration with Arch Pharmalabs. Codexis' Indian subsidiary will offer multiple pharmaceutical intermediates and APIs made with its biocatalytic processes, including intermediates used to manufacture generic atorvastatin (Lipitor), as well as the API itself.
Codexis

Dishman looks to $200m manufacturing contracts and acquisition

Dishman Pharma is currently in talks for $100-200m for its contract research and manufacturing business. Managing director, JR Vyas, puts this down to pharma companies exiting API manufacturing. Dishman is seeking an Asian acquisition to establish Carbogen Amcis as a full-service oncology package provider.
Money Control

Thursday, 21 August 2008

Wacher Chemie develops manufacturing process for RFS Pharma's Amdoxovir

Wacker Chemie

US researchers develop synthetic route to heparin

In-Pharma Technologist

Jubilant invests in North America

Jubilant Organosys is integrating its North American operations. Jubilant will align Canadian Draxis Health with US subsidiary Hollister-Stier. Jubilant has also initiated a $20m capacity expansion programme.
Business Standard

Dishman close to manufacturing contracts with Merck & Co Inc and AstraZeneca

Reuters

Sunday, 10 August 2008

CMC Biologics will manufacture a polyclonal antibody product candidate for Symphogen

CMC Biologics

AMRI Q2 profit rises 24%

Reuters

SAFC to expand HP-API capabilities

SAFC Global is to expand its high potency API manufacturing capabilities with a new 4500m2 plant in the Verona Technology Park in Wisconsin. SAFC expects to close the deal for its $30m facility on 15 Aug. The company plans to break ground in October, complete construction in 2009 with a production starting in early 2010.
Verona Press

Thursday, 7 August 2008

Lonza has established a business unit to provide engineering, facility design and maintenance services in China

Forbes

Ampac Fine Chemicals sees revenues decrease in Q3 to end June, expects full year growth

American Pacific

Cambridge Major Laboratories buys land for possible expansion

Milwaukee Journal Sentinel

API challenge for Cambrex

Despite Q2 sales rising 5% to $66.2m, Cambrex said its marginon sales decreased to 29.9% from 37.9% of sales. Cambrex said its lower sales of generic APIs were partially offset by higher custom manufacturing revenues. The company put the decrease in margins down to an unfavorable product mix, lower pricing on its largest API, and higher costs associated with the validation of the new API finishing facility in Milan, Italy.
Cambrex

FMC's speciality chemicals division sees revenues rise $2m to $41.5m in Q2

In-Pharma Technologist

Daiichi Sankyo has received approval to acquire majority control in Ranbaxy Laboratories

Times of India

Wednesday, 6 August 2008

Lilly considers selling Lafayette, IN, API facility

In-Pharma Technologist

New Institute aims to improve fine chemical processes

University of Leeds, UK, will link its research capacity with commercial needs for the fine chemical sector through its new Institute of Process Research and Development. The iPRD includes teams from the University’s School of Chemistry and School of Process, Environmental and Materials Engineering. The new institute, which is funded by industry as well as public funds, aims to develop production processes with greater efficiency and lower impact.
iPRD

NME approvals down in H1 2008

The FDA has approved only six NMEs in the first half of the year. In H1 2007 the agency approved seven. The approval level is usually similar in the second half of the year, which could mean this year is one of the wort for approvals.
In Vivo

Revenues at Synthetech increased 18% to $4.9m in its Q1 to end June

PR Newswire

Wednesday, 30 July 2008

BASF reported looking at takeover targets: WR Grace, Rockwood and Cognis in the sights?

Reuters

Call for FDA overhaul

A leading member of the US House of Representatives and a leading Congressman have called for a major overhaul of the nation's drug regulator. Representative John Dingell and Senator Chuck Grassley say there should be a taller wall between the agency and the industry it regulates. In addition they have called for the FDA to be given the authority to recall drugs, to impose significant fines on drug companies for safety violations and to inspect generic-drug makers before approving a new product. In addition, they want the next president to appoint a tough FDA commissioner completely independent from the industry. It is unlikely that any changes will happen before the elections in November, but next year may see significant changes to the FDA.
Wall Street Journal

Weylchem starts large-scale Grignard reagent manufacture at Elgin, SC, facility

Manufacturing Chemist

Sunday, 27 July 2008

Almac has broken ground at the site of its US headquarters

The Bulletin

Net profit at Piramal Healthcare rose by 57% to Rs681m in the quarter to end June

Reuters

Cobra Biomanufacturing has extended its manufacturing agreement and plans to form a joint venture with ViroMed Co. Ltd

Hemscott

Lonza predicts weaker H2, expands Hopkinton site

Lonza reported a 83% rise in first-half net profit boosted by the sale of its stake in Polynt SpA. However the company said underlying performance was "on track despite currency and raw material challenges". Lonza ceo Stefan Borgas said the company will have a "weaker" second half than the first as a number of biopharmaceuticals customers have postponed projects until next year. Lonza is adding a state-of-the-art, high-titer 2000L microbial fermentation manufacturing train in Hopkinton, MA. The plant, which is due onstream in March 2009, will meet customer demand for mid-scale microbial manufacturing.
Reuters
Bloomberg
Lonza

SAFC record sales, expects slower growth

Sigma-Aldrich's SAFC fine chemicals division reported 11% growth in Q2 and sales of $170.4m - a third successive quarter with a sales record for the company. However, the company has reduced its growth expectations from 8-9% to 5-6% as a result of "recent economic and industry conditions and discussions with customers". The company is still looking at acquisitions that may further enhance growth.
Sigma-Aldrich

Helsinn's Birex Pharmaceuticals facility in Dublin, Ireland, has successfully completed an FDA inspection

Helsinn

Tuesday, 22 July 2008

FDA to send workers overseas by end 2009

The US FDA expects to station employees in in China, India, Europe and Latin America to improve the safety of exports of food and drugs by the end of 2009. Workers will be stationed in the Middle East at a later date.
Bloomberg

Johnson Matthey sees increased fine chemicals sales in Q1

NE Business

Q2 sales rise for Albemarle's fine chemicals

Albemarle saw a 15% increase, to $151.9m, in net sales for its fine chemicals business in Q2. The company attributed the rise to higher volumes and improved pricing. However income for the sector declined $1.8m to $24.5m.
Albemarle

AMRI has doubled its laboratory capacity in Singapore

The Business Review (Albany)

Roche offers $43.7bn for remainder of Genentech

BBC

Sunday, 13 July 2008

Ashland to acquire Hercules for $2.6bn

Bloomberg

Lonza in development deal with Novartis

Lonza has entered a strategic partnership with Novartis for the scale up development and production of its pipeline of biotechnology drugs. Under the long-term partnership each product will have a specific development agreement. Lonza will provide process development and manufacturing capabilities from its R&D centre in Slough, UK, and manufacturing capacity in the US, Spain and Singapore.
Smart Money

Ranbaxy Fine Chemicals eyes US acquisition

ICICI Ventures is planning to support its Ranbaxy Fine Chemicals Ltd company in the acquisition of the fine chemicals division of Mallinckrodt Baker. The $400m deal will treble the size of RFCL.
NDTV

Thursday, 10 July 2008

Inspectors collaborate

The US, Europe and Australia will share data from manufacturing facility inspections to cover a wider territory and more facilities than they could alone. The pilot programme will concentrate on inspecting facilities in countries such as China and India.
Associated Press

Dow to acquire Rohm & Haas for $18.8bn

Bloomberg

Penn acquired by Minakem

The assets of Penn Specialty Chemicals have been acquired by PennAkem, a wholly-owned subsidiary of the French Minakem Group. The acquisition makes PennAkem the preeminent supplier of furfural and furan derivatives.
Minakem

Rentschler to expand biomanufacturing and exit pharma

Rentschler will invest €14m to expant the biomanufacturing capbilities at its Laupheim site. At the same time it has sold its pharmaceutical manufacturing business to Riemser Arzneimittel, which will expand its contract manufacturing business with the acquisition.
Rentschler

Aquapharm in Dr Reddy's licensing deals

Aquapharm Biodiscovery has signed a new license agreement with Dr Reddy's and has extended an existing deal. The original deal was signed with Dowpharma, which was acquired by Dr Reddy's earlier this year, in 2006. The agreement covers the use of selected strains from Aquapharm's library of novel marine micro-organisms to generate commercial biocatalysts for the manufacture of pharmaceutical intermediates.
Aquapharm

Albemarle to manufacture ibuprofen for Dr Reddy's

International Business Times

Sunday, 6 July 2008

World Bank group invests in Hikal

Hikal has received a $15m equity investment from International Finance Corporation, part of the World Bank group. Hikal said it plans to use the capital to expand its manufacturing and R&D facilities in Jigani, Panoli and Taloja.
Money Control

Wednesday, 2 July 2008

Lonza commits to stem cells

Lonza will produce clinical trial and commercial supplies of Osiris Therapeutics' adult stem cell therapy, Prochymal. Lonza will build new facilities in Walkersville, including the first commercial-scale allogeneic cGMP manufacturing facility and capacity to manufacture cGMP grade cell culture media for therapeutic applications.
Forbes

Monday, 30 June 2008

Plethico plans to cut CMO business

Plethico Pharmaceutical is looking at trimming its Contract Research and Manufacturing Services (CRAMS) business as low margins are being further squeezed out due to higher inflation and surging crude oil prices.
Economic Times

Rentschler Biotechnologie has started operation of its 250-L multi-process mammalian cell production suite

Rentschler Biotechnologie

Emcure inaugurates plants

Indian manufacturer, Emcure Pharmaceuticals, has inaugurated its commercial oncology products manufacturing plant in Hinjewadi. In addition, Emcure's Gennova Biopharmaceuticals subsidiary has inaugurated its trial-scale malaria vaccine manufacturing facility.
Economic Times

Wednesday, 25 June 2008

FDA funding approved

The US House Agriculture subcommittee has approved funding of $2.1bn for the FDA in 2009 - $282m more than the agency originally requested.
Health Imaging

Avid joins PER-C6 network

Avid Biosciences will be the pre-approved contract manufacturer for licensees of DSM and Crucell's PER.C6 cell line located in the western US.
RTT News

Saltigo expects to meet 5% profit goal

Bloomberg

DHS notifies high risk facilities

The US Department of Homeland Security (DHS) is informing the owners that 7000 chemical facilities have been designated as "high risk" in the face of terrorism attack. SOCMA has welcomes the DHS action to secure chemical facilities according to risk under its Chemical Facility Anti-Terrorism Act Standards.
HS Today

Thursday, 19 June 2008

PacificGMP will build biomanufacturing facility in China following merger with Pacific Biopharma

PR Newswire

China grants approval for FDA offices

Reuters

US Senator calls for pharma outsourcing probe

Pharmalot

Eden Biodesign is to build a biomanufacturing facility in US

Eden Biodesign

CEFIC and DSM criticise EU API measures

CEFIC and DSM have said the European Commission's proposals for tackling counterfeit APIs do not go far enough. Responding to the public consultation both parties believe APIs in medicines destined for the EU market must comply with GMP and that there are concerns over some APIs originating from India and China.
In-Pharma Technologist

Dishman builds in China

Dishman Pharmaceuticals has invested $10m in an API and intermediates facility in Shanghai, China. The facility which is due onstream early in 2009 will support Dishman's contract manufacturing business.
Sify

Monday, 16 June 2008

FDA considers outsourcing inspections

The US FDA is looking to outsource the inspection of pharmaceutical manufacturing facilities. However, there are concerns after the relative failure of a similar system used for medical devices.
San Diego Union-Tribune

Further production boost for PER-C6

DSM And Crucell have further enhanced the productivity of their PER-C6 human cell line. Just three months after announcing the cells could produce 15g/l they have announced that they can achieve production levels of 27g/l.
Reuters

Thursday, 12 June 2008

Evonik may sell more shares

Hemscott

Daiichi to acquire Ranbaxy stake

Japanese pharmaceutical company Daiichi Sankyo will acquire a controlling stake in Indian generics manufacturer Ranbaxy for $4.6bn. Analysts believe the deal may start a string of western takeovers in the Indian pharmaceutical sector. Ranbaxy is believed to have talked to other companies including Takeda, GlaxoSmithKline and Pfizer. Sources suggest Pfizer may bid for a further stake in Ranbaxy.
AFP
Times of India
Business Standard

pecter slams Administration over FDA cash

Just days after the Bush Administration called on he US Congress to authorise an additional $275m for the FDA, Senator Arlen Specter has criticised the timing in the Administration Request. Specter believes the FDA needs the money asap, but the Administration request would deliver the money in March or April 2009. Specter is highly critical in his letter to Secretary Leavitt.
Wall Street Journal

BASF has developed a new class of enzymes for producing chemically sophisticated chiral molecules

BASF

Avecia has added formulation studies to its portfolio

Avecia

Angel Biotechnology will manufacture GMP clinical trial GMP material for Novolytics

InvestEgate

Arch buys into Benzochem

Arch Pharmalabs has acquired 70% of Benzochem Lifesciences for around $23m. Benzochem specialises in manufacturing oncology products.
In-Pharma Technologist

Administration asks for more cash for FDA

US Health and Human Services Secretary Michael Leavitt has asked Congress to give the FDA an additional $275 million in next year’s budget to enhance the safety of food and medical products.
New York Times

Cobra Biomanufacturing will produce ViroMed’s Master Cell Bank and GMP-grade VM206RY plasmid DNA treatment for clinical trials

Cobra

Cambridge Major has broken ground on its expansion project

WISbusiness
Previously on FINE

Matthey takes stake in Dr Reddy's subsidiary

Johnson Matthey is to buy a 49% stake in Macred India, the subsidiary of Dr Reddy's dedicated to the manufacture of narcotic drugs from opium.
Economic Times

Thursday, 5 June 2008

Johnson Matthey's Fine Chemicals and Catalysts business saw sales increase 13% to £303m

InvestEgate

Central Glass acquires Girindus business

Girindus has sold its Halle-Kuensebeck, Germany, process development, upscaling, cGMP production of active pharmaceutical ingredients as well as the fine chemical business and all related analytical activities to Central Glass Germany.
Girindus

CVC wins Evonik race, IPO planned

CVC Capital Partners has won the race to acquire a stake in Evonik. The private equity house has acquired a 25.01% stake in the German industrial Group for €2.4bn. Wilhelm Bonse-Geuking, CEO of Evonik's parent company, the RAG Foundation, said that RAG plans to IPO Evonik after mid-2010 and before 2013.
CVC
Bloomberg
Hemscott

Tuesday, 3 June 2008

Dow Chemical has settled its litigation against former executives

Reuters

CVC expected to win Evonik race

As the Evonik decision day draws closer, it has been revealed that RAG now plans to sell a 25.01% stake in Evonik, giving the buyer a veto vote. Reports suggest that CVC Capital Partners is the winning bidder. CVC is set to pay €2.4bn for the stake, beating bids from Bain Capital, Blackstone Group and Kohlberg Kravis Roberts.
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Reuters

Sunday, 1 June 2008

Evonik decision due 11 June

Evonik's parent company RAG will decide on 11 June which of the four interested financial buyers will get the 25% stake in the company. Sources suggest the workers union liked the presentations from KKR.
Forbes

Wednesday, 28 May 2008

Jubilant Organosys has completed its acquisition of Draxis Health

Draxis

Safety concerns slow FDA approvals

Janet Woodcock, director of the US FDA's Center for Drug Evaluation and Research, has said that a new focus on drug safety is delaying the approval of some medicines. She said the Agency's hiring programme would help offset the delays.
Reuters

Tuesday, 27 May 2008

Cytovance Biologics will manufacture an antibody for ImmunoGen

Business Wire

FDA awaits China approval

The US FDA is awaiting approval from the Chinese Ministry of Foreign Affairs before it can establish offices in China. The FDA plans to open offices in Beijing, Shanghai and Guangzhou.
Associated Press

Chemtura for sale?

Private equity firms Blackstone Group and Apollo Management LP are said to be in talks to acquire Chemtura. Chemtura is currently reviewing strategic alternatives that could include divestitures, acquisitions or a sale.
Forbes

Lonza has acquired Amaxa AG to enhance its Cell Discovery business

Hemscott

Thursday, 22 May 2008

Unipex Group has acquired the active ingredients and specialty chemicals division of Atrium Innovations for $166m

PR Newswire

Dr Reddy's reveals Dowpharma and BASF costs

Dr Reddy's spent $38m on BASF's Shreveport manufacturing plant and $34m on Dowpharma's UK assets in Mirfield and Cambridge. The figures were revealed as the company revealed that its full year 2007-2008 profit fell almost 50% to $117m.
The Hindu

Wednesday, 21 May 2008

SOCMA certifies facilities

SOCMA has certified the first five facilities to complete the required steps of its Chemstewards programme review cycle. The five facilities, which completed the requirements a year ahead of schedule are: Synthetech in Albany, Oregon; Noramco in Athens, Georgia; Noramco in Wilmington, Delaware; Siegfried USA in New Jersey and ESCO Company in Muskegon, Michigan.
SOCMA

Cobra Biomanufacuring wins vaccine manufacturing award

Cobra Biomanufacturing

Tuesday, 20 May 2008

FDA to get subpoena powers?

Congressman Bart Stupak hopes that FDA chief Andrew von Eschenbach will seek subpoena power as part of the impending drug importation bill. The power will allow the FDA to demand certain documents from regulated companies.
Wall Street Journal

FMC to buy ISP alginates business

CNN

Sill four for Evonik

Four potential buyers are still lined up for the acquisition of a 25% stake in Evonik. KKR, Blackstone Group, Bain Capital and CVC Capital Partners are awaiting a decision by Evonik owner RAg on which two will go forward to the negotiation stage.
Forbes

Nicholas Piramal wants further custom manufacturing investments in the US and western Europe

Money Control

Saturday, 17 May 2008

Evonik to invest €2.5bn in chemicals unit

Hemscott

FDA confirms China plans, will ban exporters

On a trip to China the head of the US Health Secretary, Michael Leavitt, conformed that the FDA will open offices in China. The FDA will station 10 staff at three offices across the country. Leavitt also said the FDA plans similar offices in India. In addition, Leavitt said the US plans to ban Chinese companies that don't meet certification requirements form exporting goods to the US.
China Daily
Wall Street Journal

Chemie Uetikon launches biotech division

BioUetikon, the biotech custom manufacturing division of Chemie Uetikon, has been launched in Ireland. BioUetikon, a spin-out from Dublin City University funded by Chemie + Papier Holding, Chemie Uetikon's parent company, will offer manufacturing services to the biopharmaceutical, medical device and related industries.
Pharmaceutical Technology

Anu's Laboratories sees IPO subscribed eight times

Economic Times

FDA approves BASF excipient

BASF

Thursday, 15 May 2008

FDA NME approvals at all time low rate

Although the US FDA has approved 29 new drug applications in the first four months of 2008 - the highest level since 2000 - it has only approved three NMEs, equalling the record low level.
Pharmalot

Wednesday, 14 May 2008

SynCo Bio Partners has completed the manufacture of ActoGeniX’ AG011 for a Phase II clinical trial

SynCo Bio

Major expansion

Cambridge Major Laboratories plans to build North America's most advanced API facility at its Germantown, WI, headquarters. The 12,000m2 facility will include multiple GMP manufacturing suites capable of producing multi-tonne quantities of API. The company said the facility, which is scheduled for August 2009, is required to meet its large and growing pipeline of late developmental and commercial API’s.
The initial build will house six manufacturing suites with reactors up to 7500L with complete isolation and containment and vessels for hydrogenation and cryogenic reactions. Additional manufacturing suites up to 15 000L can be accommodated in the facility if needs arise.
Small Business Times
Image from Business Wire

FDA asks for cash

Andrew von Eschenbach, the US FDA Commissioner, has asked Congress for an additional $275m above the previously proposed budget. von Eschenbach's request includes a detailed spending plan which includes opening new foreign offices, increasing inspections and constructing new databases to track drug hazards.
New York Times

Tuesday, 13 May 2008

Albemarle plans fine chems acquisitions

Albemarle's fine chemicals business unit will focus on targeting the pharmaceutical market, said Ron Gardner, vice-president fine chemicals, speaking at the company's Vision 2010 investor meeting. Gardner said the company plans to develop its API and pharmaceutical intermediates businesses. The company also plans to build its capabilities first in Europe and then in India to be nearer to some of its customers and potential customers. The business is already expanding its R&D capabilities in Asia with teams in India and China.
The company is also building its brand image in the sector by working with its customer to publicise the relationships it develops. Albemarle's current pharma pipeline has 38 projects in preclinical development, 51 in phase I, 14 in phase II and 20 in phase III - the most it has ever had in pIII. Gardner said its pipeline was worth more than $100m in sales.
Acquisition will form part of the company's plan to grow the business, said Gardner. The company plans to acquire businesses that deliver $250m in sales to take the fine chemical business unit sales to $1bn by 2010.
As for competition in the arena from China, Gardner said the company was seeing customers that were hesitant to take business to China. In addition he sees the economic environment changing such that Western manufacturers are seen as relatively more attractive as china becomes relatively less competitive.
Albemarle presentation

Biopharma CMO market grows

The global biopharmaceutical CMO market grew 14% to $2.4bn in 2007, according to a report from HighTech Business Decision. For 2008, the market is expected to grow a similar amount.
Contract Pharma

Thursday, 8 May 2008

Jubilant Organosys has acquired pyridine derivatives manufacturer Specialty Molecules Pvt Ltd for $4.8m

Business Standard

Agilent expands nucleic acid capacity, buys Dow technology

Agilent Technologies is expanding nucleic acid API manufacturing capacity at its Boulder, Colorado, facility. Additionally, Agilent has purchased the assets of Dowpharma's Nucleic Acid Medicines business, the second disposal by Dowpharma in the same number of weeks. In Boulder Agilent is adding large-scale nucleic acid synthesis, purification and drying capacity. The new capacity is due on stream by the end of 2008.
Agilent

Dishman expands API capacity

Dishman Pharmaceuticals and Chemicals has commissioned three API facilities for contract manufacturing. The $37.5m facilities are in Bavla, India. Dishman plans to commission a fourth facility dedicated to the production of cytotoxic compounds by the end the year.
India PR Wire

Wednesday, 7 May 2008

Dr Reddy's plans more acquisitions

GV Prasad, executive vice-chairman and CEO of Dr Reddy’s Laboratories, said the company plans to acquire more small companies globally rather than one large deal to push sales in overseas markets. It is looking at acquisitions including custom pharma services in the US and other markets.
Economic Times

Cobra Biomanufacturing raises £1m to upgrade its Oxford facility to meet FDA requirements for commercial virus production

Cobra Biomanufacturing

Anu's to invest in plants

Anu's Laboratories plans to use the proceeds of its forthcoming IPO to build an API manufacturing plant and a pilot plant for contract research and manufacturing in Vishakhapatnam, India.
Economic Times

Tuesday, 6 May 2008

Reaxa launches second generation encapsulated catalyst for use in flow processes

Reaxa

AMRI sees sales rise, completes high potency facility

Revenue for Q1 rose 11% to $53.6m for AMRI. Discovery, development and small-scale manufacturing saw strong growth, but large-scale manufacturing saw a sales decline. In addition, AMRI has completes its new state-of-the-art 150m2 non-GMP High Potency development laboratory suite at its Albany, NY, facility.
AMRI

Friday, 2 May 2008

QSV Biologics will manufacture a recombinant protein under development by Pfizer

Earth Times

Dr Reddy's completes Dowpharma and BASF acquisitions

Centre Daily Times

Cambrex Q1 sales drop 5%

Cambrex

Albemarle to move HQ to Baton Rouge

Albemarle

Pfizer, finally, confirms biologics facility in Ireland

Irish Times

FDA Director back-tracks

The director of the US FDA's Center for Drug Evaluation and Research, Janet Woodcock, refused to support Democrat proposals for tougher regulations on imported drugs and new fees on drug makers. Despite earlier comments that the FDA needs an additional $225m to inspect all foreign manufacturing facilities Woodcock refused to specify how much the agency needs.
Wall Street Journal

Wednesday, 30 April 2008

Goodwin Biotechnology has completed expansion of its biologics custom manufacturing facility

Goodwin biotechnology

FDA asks for cash

The director of the US FDA’s Center for Drug Evaluation and Research, Janet Woodcock, has told the House Energy and Commerce subcommittee on oversight and investigations that the FDA would need $225m - 20 times more than its current foreign inspection budget - in additional funding to inspect the 3300 foreign drug-making plants as frequently as it reviews plants in the US.
Los Angeles Times

Dr Reddy's buys US facility

Continuing the moves of Indian companies acquiring western manufacturing facilities, Dr Reddy's has acquired the Shreveport, Louisiana, custom manufacturing plant from BASF. GV Prasad, Dr Reddy's Vice Chairman and CEO, said the purchase was "an infrastructure play to support our North American generics business".
Money Control

SOCMA criticises call for US-REACH

Jim DeLisi, president of Fanwood Chemical, representing SOCMA told a US Senate Environment and Public Works Committee hearing that "an American REACH would not only hamper innovation but would reverse progress made over many years by federal regulators and the chemical industry to appropriately manage risk”. The committee chair, Senator Barbara Boxer has called for US chemical producers to be responsible for proving their products are safe before entering the market.
ICIS

ProBioGen has begun a biologics manufacturing technology integration deal with Boehringer Ingelheim

ProBioGen

Tuesday, 29 April 2008

Angel's Estonian deal

Angel Biotechnology will provide biomanufacturing services for EPhaG AS. Angel will support the production of four products over the next three years, for which it will get royalty payments for five years on the sale of the first three products. EPhaG will make a £1m investment in Angel.
Hemscott

DSM expects its Pharmaceutical Products business to recover from a weak first quarter

In-Pharma Technologist

Sunday, 27 April 2008

FDA calls on pharma to oversee quality

Janet Woodcock, director of the US FDA’s Center for Drug Evaluation and Research, told the Senate Education, Labor, Health and Pensions Committee that the increasing number of ingredients sourced from overseas makes it almost impossible for the agency to ensure the safety of all drugs sold in the US. Woodcock said responsibility also lay with the pharma companies ensuring their ingredients reached quality standards.
PharmaLot

Friday, 25 April 2008

Archimica sells plant, completes turnaround

Archimica has sold its Puerto Rico 5-fluorouracil plant to Teva. The sale completes the company's turnaround to multi-purpose facilities for manufacturing intermediates and APIs.
Archimica

Wednesday, 23 April 2008

Record quarter for SAFC

SAFC saw record quarterly sales of $157.5m in Q1 2008 a growth of 18.2%. The company reported continued strong demand from pharmaceutical customers in the US and improved demand from biotech customers worldwide. Booked orders are at an all time high for SAFC.
PR Newswire

Jubilant sees 38% sales increase in year to end March 08

Business Wire

Tuesday, 22 April 2008

FDA weak on foreign inspections

The US Government Accountability Office has criticised the FDA for not conducting enough inspections of manufacturing facilities outside the country. in 2007 the FDA inspected 30 inspections this year it plans to conduct 50. However there are 3200 foreign drug firms listed by the FDA.
Associated Press

Pfizer to cut more manufacturing

Pfizer will close or sell 13 more manufacturing facilities as it cuts its number of production plants to 44 by the end of 2009. CFO Frank D'Amelio, was implementing an outsourcing programme.
In-Pharma Technologist

Evonik confirms bidders

Evonik ceo Werner Mueller has confirmed the four parties interested in acquiring the 25% stake the company is selling. They are Blackstone Group, Kohlberg Kravis Roberts, Bain Capital and CVC Capital Partners. Binding offers are expected by June.
Bloomberg
Previously on FINE

Albemarle sees 4% drop in Q1 fine chemicals sales

Houston Chronicle

Indian companies shopping for CMOs

Indian life sciences companies are seeking acquisitions in the US and Europe in the chemistry and custom synthesis space.
Financial Express

Friday, 18 April 2008

Origin labels for drugs proposed

Democrats on the US House Energy and Commerce Committee have proposed county of origin labels for drugs. The labels would have to identify the source of the active ingredient and its place of manufacture.
Associated Press

Wednesday, 16 April 2008

DSM Biologics will optimise Upfront Chromatography’s fully disposable chromatography system for its biopharmaceutical production

Business Wire

Senators: FDA underfunded

Following a US Senate Appropriations Committee hearing, Senators from both parties said the FDA needed more funding than proposed by President George Bush.
New York Times

Analysts suggest Clariant and Ciba are takeover targets

Bloomberg

AZ to outsource all manufacturing

AstraZeneca chief executive David Brennan said the company plans to outsource all API manufacturing within a decade. AZ has piloted the outsourcing of API for Seroquel and is will extend outsourcing to low-cost third-party manufacturers, especially in India and China.
Financial Times

Tuesday, 15 April 2008

FDA to open China office in May

The US FDA is to open three offices in China by October, the first beginning operations next month. Agency Commissioner Andrew von Eschenbach said it eventually hopes to open offices in India, Europe, the Middle East and South America.
Wall Street Journal

Monday, 14 April 2008

Sumitomo will be the exclusive sales agent for Chiral Quest's chiral products in Japan and selected worldwide accounts

Earth Times

Laureate Pharma to manufacture Alopexx Pharmaceuticals’ mAb F598 antibody

Laureate Pharma

Codexis files for IPO

Codexis hope to raise around $100m in an IPO underwritten by Credit Suisse Securities, Goldman Sachs, Piper Jaffray, RBC Capital Markets and Thomas Weisel Partners. Codexis did not reveal the offer price or number of shares to be sold in its submission to the SEC. Last year Codexis had sales of $25.3m but made an overall loss of $39m. Since it was founded as a spin out from Maxygen, Codexis has accumulated a deficit of $94.2m.
Forbes

Saturday, 12 April 2008

Almac facility under threat from waste plant

Belfast Today

Evonik plans chemicals acquisitions

Klaus Engel head of Evonik's chemicals division said the company is ready to make acquisitions again. The Degussa division has a budget of about €2.5bn for expansion in China, South America and Europe over the next three years.
Hemscott

Thursday, 10 April 2008

Actavis buys in China

Actavis has purchased a 90% of Zhejiang Chiral Medicine Chemicals. The purchase of the Hangzhou-based API manufacturer is designed to help reduce costs.
In-Pharma technologist

Tuesday, 8 April 2008

Laureate Pharma to manufacture Cytheris’ Interleukin-7 (IL-7), a fully glycosylated recombinant human protein

Laureate Pharma

Overhaul coming for FDA

Congressional Quarterly reports that John Dingell, who heads the House Energy and Commerce Committee, is planning a fundamental overhaul plan that is likely to form the model for a Democratic or Republican White House following the US elections later this year. Dingell plans more full time inspectors in the developing world, adding country of origin labeling and levying new user fees on manufacturers to finance spot checks at overseas drug plants and at US points of entry.
PharmaLot

Calls for FDA to label products with origin of ingredients

Wall Street Journal

Monday, 7 April 2008

India faces pharma manufacturing threat from China

Business Standard

FDA to hire

The FDA plans to hire more safety evaluators, epidemiologists, regulatory project managers and experts in risk management and medication errors to enhance its postmarket drug-safety activities.
FDA News

Saturday, 5 April 2008

Jubilant buys Draxis

Jubilant Organosys is to purchase Draxis Health for $225m. Jubilant said the deal gives it "an entry into the attractive, regulated, high growth and high margin radiopharmaceutical business".
Reuters

Friday, 4 April 2008

Atrium Innovations will sell its active ingredients and specialty chemicals division AXA Private Equity for $155m

Reuters

Archimica is expanding capacity for cryogenic production of boronic acids in Germany and France

Archimica

Carbogen adds high potency in India

Carbogen Amcis' Indian subsidiary will open a high potency facility on the Bavla site of its parent company, Dishman Pharmaceuticals & Chemicals Ltd. The 4300m3 facility, which is expected to be operational by Q1 2009, will include four segregated high potency cells with reactor sizes ranging from 630L to 1600L and a number of contained development laboratories.
Carbogen Amcis

Thursday, 3 April 2008

Schering-Plough to cut manufacturing

Playing its part in the wave of cut backs in the pharma sector, Schering-Plough plans to reduce its head count by 10% and its number of manufacturing plants.
Wall Street Journal

Evonik bidders named

Insiders say that Blackstone Group, Kohlberg Kravis Roberts, Bain Capital and CVC are the preferred bidders for a stake in Evonik. They are each believed to have bid €2bn.
Reuters

Lonza to expand nicotinate capacity

Lonza will expand its manufacturing capacity for nicotinates by 40% over the next three years to meet demand. The first phase of the SFr50m investment is due on-stream in 2010 with full operation in 2011.
Forbes

Wednesday, 2 April 2008

PharmAthene has completed its acquisition of Avecia’s biodefense vaccines business

PharmAthene

Evonik field down to four

RAG has ruled out an IPO for part of its Evonik business for the time being. It plans to sell a 25% stake this year, with a further 50% stake sold between 2010 and 2012. Reports suggest there are four potential buyers for the current stake, one of which is Blackstone Group.
The Guardian
CNN

Tuesday, 1 April 2008

Alpharma has completed the sale of its API business to 3i for $395m

Alpharma

Dowpharma sells UK assets

Dowpharma has sold its small molecules facilities in Mirfield and Cambridge, both in the UK, to Dr Reddy's. Although the actual transaction cost was not revealed, G V Prasad, vice-chairman and ceo of Dr Reddy's, said the cost was slightly above the business's $25m revenue. The acquisition will include the relevant business, customer contracts, associated products, process technology, intellectual property, trademarks as well as the transfer of the facilities. Dr Reddy’s will also have a non-exclusive license to Dow’s Pfenex Expression Technology for biocatalysis development.
Bloomberg
Money Control

Thursday, 27 March 2008

FDA may fail

FDA commissioner Andrew von Eschenbach said the agency may fail to protect the health of Americans as funding has not kept pace with responsibilities. He said the FDA's regulatory role has expanded and its workforce has been overextended. He said that in order that the FDA remains the "the world's gold standard as a regulatory agency" it needs to be "stronger, bigger and better".
Bloomberg

Acquisitions for Lonza?

Lonza shareholders are advising ceo Stefan Borgas to look at larger acquisitions to expand in life sciences including drug ingredients and nutritional additives, rather than return cash to investors. Borgas said the company will have a "much tougher" time reaching profit targets this year because of rising raw-material costs and a sliding dollar.
Bloomberg

Wednesday, 26 March 2008

Rhodia to dismantle Organics business

In-Pharma Technologist

WC Heraeus will manufacture picoplatin for Poniard Pharmaceuticals

San Francisco Business Times

FDA plans to reduce drug development costs

Janet Woodcock, the recently reappointed head of the FDA Centre for Drug Evaluation and Research said the FDA would unveil proposals this autumn on reducing drug development costs by standardising the format and content of clinical trial data.
Financial Times

Saturday, 22 March 2008

Cambrex customer recalls product

A customer of Cambrex has recalled a product for which Cambrex currently supplies the API. However, Cmabrex said the recall is not linked to its performance as the manufacturer of the API. The recall will affect its finances for 2008, said Cambrex.
Forbes

Friday, 21 March 2008

Avecia sells vaccines

Avecia has sold its vaccines business to PharmAthene for $20m. Avecia will also be eligible for $20m in milestone payments. The business will remain in the UK.
Baltimore Buisiness Journal

Tuesday, 18 March 2008

China's State Food and Drug Administration now governed by the Ministry of Health

Chemistry World

Eleven now interested in Evonik

The German press is reporting that 11 companies are interested in the 25% stake in Evonik that is up for sale. Apollo Management, Bain Capital, BC Partners, Blackstone Group, Carlyle, Cerberus, CVC, Kohlberg Kravis Roberts, One Equity Partners, Permira and TPG are said to have contacted Evonik.
Reuters

Biotech offsets fine chemicals decline for Wacker

Wacker's fine chemicals business matched 2006 sales in 2007. The company said higher sales of biotech products offset its declining business in custom fine chemicals and catalog products.
Wacker

New projects boost Siegfried profits

Siegfried Holding saw full-year net profit rise 54% to SFR49.7m. Siegfried put the rise down to acquiring 20 new API projects and 'increased interest of pharmaceutical research firms'.
Forbes

Monday, 17 March 2008

Goodwin Biotechnology to manufacture antibody for Q Therapeutics

Goodwin Biotechnology

GMP not required for excipients

A European Commission report suggests that introducing GMP for pharmaceutical excipients is unlikely to bring benefits, despite industry warnings of safety issues. The European Fine Chemicals Group (EFCG) has called for mandatory GMP to level the playing field among manufacturers of pharmaceutical excipients and bring the sector into line with other aspects of the pharmaceutical production process.
In-Pharma Technologist

More money proposed for FDA

The US Senate has passed a budget resolution to give the FDA an additional $375m over this year. “Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the FDA,” said Senator Edward Kennedy, Democrat of Massachusetts, who pushed for the new financing.
New York Times

Good 2007 for Evonik, still looking for sale

Evonik saw sales rise 2% to €14.4bn and EBIT rises 14% to €1.3bn. The Chemicals business benefited from higher demand, an improvement in selling prices, lower depreciation and the recent restructuring. The company is still looking either to sell shares in an IPO or for a trade sale of a stake.
Evonik
Reuters

Sunday, 16 March 2008

FDA increases China staff

The FDA plans to strengthen its regulatory presence in China. The agency will establish eight permanent positions at US diplomatic posts and will also hire five Chinese nations.
Chicago Tribune

Thursday, 13 March 2008

CMC ICOS will develop a production cell line for Raven’s RAV18 monoclonal antibody

CMC Biologics

Hikal invests in manufacturing

Hikal is establishing manufacturing units in Bangalore, to supply pharmaceutical products for Pfizer and Alpharma, and a pharmaceutical intermediate manufacturing facility near Mumbai. In addition, it is setting up a pharmaceutical and crop protection R&D centre in Pune and a crop protection active ingredients facility in Navi Mumbai. Total investment is approximately $50m.
Business Standard

RFCL on European shopping spree

RFCL Ltd is close to acquiring a European fine chemicals company. The former Ranbaxy Fine Chemical Ltd has recently closed the acquisition of a European animal healthcare company. RFCL expects the fine chemicals deal to be confirmed in April.
Domain B

Cobra Biomanufacturing has received R&D tax credit approval from the French Ministry for Higher Education and Research

Cobra Biomanufacturing

Wednesday, 12 March 2008

Nicholas Piramal seeks Euro/US acquisition

Nicholas Piramal India is seeking acquisition opportunities in the US and in Europe to expand the customer base and technology range of its contract manufacturing business. An acquisition in the US is most likely said group chairman Ajay Piramal. Additionally, the company will rebrand its contract manufacturing business as Pharma Solutions.
Economic Times

Asian competition forces Rhodia to close last paracetamol plant in Europe

CNN

Analyst: Fewer NME approvals expected in 2008

Investment analyst, Jim Kumpel of Friedman Billings Ramsey, says NME approvals are “on pace with a miserable 2007". Through the first two months of this year, the FDA has approved only one NME, which is the same rate as 2007.
Pharmalot

Tuesday, 11 March 2008

Lanxess sets criteria for acquisitions

Lanxess ceo Axel Heitman said the company will continue to look for acquisition targets to bolster growth. However, it has outlined three possible scenarios for acquisition targets: the acquisition of individual small or medium-sized operations; the acquisition of chemical businesses to broaden the portfolio; or the acquisition of companies or part of companies with potential that has not yet been fully realised.
Forbes

Woodcock reappointed to head CDER

Wall Street Journal

DSM, Crucell see 15gl-1 yield with PER.C6

Reuters

EMEA expects record year

The European Medicines Agency (EMEA) expects a record number of applications for market approval in 2008, according to its annual report. The Agency expects to surpass the record number of positive opinions issued in 2007.
Pharma Times

Friday, 7 March 2008

SOCMA opposes IST legislation

Joe Acker, president of the Synthetic Organic Chemical Manufacturers Association (SOCMA), said his trade group is “stridently opposed to the merits of mandating inherently safer technology under the guise of site security”. Acker's comments follow the approval by the House Committee on Homeland Security approved the “Chemical Facility Anti-Terrorism Act of 2008" which includes the inherently safer technology (IST) reporting requirement.
ICIS

Thursday, 6 March 2008

Link Technologies opens new kilo-scale facilities

Link Technologies

Evonik acquires in China

Evonik has acquired the remaining 49% of its former joint venture Degussa Lynchem Co. Ltd., Dalian, China, from the Chinese shareholders Yuncai Wang and Jingkun Wang. Degussa Lynchem has become a wholly owned subsidiary of Evonik.
Degussa

10 bidders lined up for Evonik

Reuters

Hovione invests in China

Hovione has purchased 75% of Hisyn Pharmaceutical Co. Limited, based in Zhejiang. Hovione said the acquisition provides it with significant additional drug substance manufacturing production capacity and strengthens its 20 year presence in China. The acquisition includes development labs and a 22,000m2 API) plant, which will now produce Hovione's two largest volume products.
PR Newswire

Merck invests in research centre

Merck KGaA will spend €47m on a new research centre at its Darmstadt headquarters. The centre will bring together the research activities of the liquid crystal and performance and life science chemicals businesses. Construction will begin in June and inauguration is planned for the end of 2009.
CNN

Eden in manufacturing deal with Stealthyx

Eden Biodesign will produce Stealthyx Therapeutics' lead therapeutic candidate. Stealthyx is evaluating for treatment of a range of inflammatory diseases including rheumatoid arthritis.
Eden Biodesign

Tuesday, 4 March 2008

Friday, 29 February 2008

FDA needs more funds

The Leaders of the US Committee on Energy and Commerce have said that the FDA needs an injection of funds seven times that proposed by President Bush in his budget.
Committee on Energy and Commerce

Thursday, 28 February 2008

China says: buyer beware

China's State Food and Drug Administration (SFDA) said that the ultimate responsibility for imported drug ingredients lies with the importing country.
Lab Technologist

Cobra in SARS protein deal

Cobra Biomanufacturing will carry out downstream processing for a protein from the SARS virus for an undisclosed pharmaceutical company. The protein will be manufactured by the pharma partner and will be used in phase I trails.
Cobra

Lonza reclassified as life sciences and biotechnology company

Hemscott