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

Sunday, 12 February 2012

SAFC continues to grow sales

Full year sales at Sigma Aldrich rose 10% to $2.5bn, with the SAFC business growing 9% during the year. The company said it expected the SAFC business to show low to mid single digit growth in the first half of the year and low double digit growth in the second half of the year as additional capacity comes on line in China and Taiwan.
Seeking Alpha

Revenues rise for AMPAC

AMPAC reported a 55% increase in fine chemicals segment revenues to $21.5m in its Q1 2012. Dana Kelley, AMPAC vice-president, CFO and treasurer, said that revenues from antiviral products were the primary contributor to the rise as the 2012 first quarter included no antiviral product revenue. Joe Carleone, AMPAC president and CEO, said the company had recently agreed to produce controlled substances for a large pharmaceutical customer and will soon be conducting a full scale validation of a chemical product in this area.
Seeking Alpha

Lonza's new factory concept

Lonza is establishing a new manufacturing concept at its Vis, Switzerland site. The company said that continuous flow and microreactor technologies will allow it to offer increased flexibility and capacity for the development and manufacture of APIs. Lonza added that the facility will be ready for full operation in June 2012.
Manufacturing Chemist

Contract manufacturing sales up for AMRI

Contract manufacturing sales at AMRI rose in 2011. The company reported a rise of 4% to $36m for its development and small scale manufacturing and 20% to $95.6m for large scale manufacturing.
AMRI

Sales rise at Cambrex; looks to acquire

Cambrex reported a sales rise of almost 6% to $67.1m in Q4 2011, which the company attributed to increased demand for an API manufactured under a long-term supply agreement, a recently approved innovator product, higher sales of generic APIs, and higher volumes of controlled substances and products utilising its drug delivery technology. Cambrex CEO, Steven Klosk, said the company is looking to add further capabilities in generic finished products.
In-pharma Technologist

Saturday, 11 February 2012

Hikal's Jigani, Bengaluru, API manufacturing facility has successfully completed its third US FDA audit


Pharmabiz

Codexis looks to future

Codexis' full year 2011 product revenue rose 49% to $49.0m as a result of increased sales to both generic and innovator pharmaceutical customers. Codexis President and CEO, Alan Shaw, said that in 2012 the Codexis' customers received FDA and EMA approvals for three new on-patent drugs using the company's technology. Shaw said he expects to see improved sales growth in 2012. Additionally he said Codexis is expecting the FDA to approve the manufacturing process for blockbuster pharmaceutical product, which has approaching $4bn in sales. He sees additional growth from increased volumes of generic atorvostatin using the company's technology and more companies using their products in their process development.
Codexis

Wednesday, 8 February 2012

New contract for Angel

Angel biotechnology has signed three new manufacturing contracts with Materia Medica Holding, worth £4.5m. Angel will start the projects at its Edinburgh facility before transferring later this year to its refurbished, larger site at Cramlington, UK.
The Herald

Aesica to expand HPAPI capabilities

Aesica is to upgrade its API manufacturing capabilities to enable the company to manufacture high potency APIs at commercial scale. Following the upgrade, Aesica will be able to manufacture SafeBridge Category 3 API and formulated products from pilot to commercial scale at two of its sites in Europe.
Aesica

Wednesday, 1 February 2012

Q3 sales rise at Johnson Matthey

Johnson Matthey's fine chemicals division reported sales up 15% to £62m in its Q3 ended 31 December 2011. The company said its API manufacturing business performed well aided by sales of a new API for the treatment of drug addiction. Looking forward Matthey said the underlying performance of the division is more predictable and it continues in line with expectations.
Johnson Matthey

SAFC gets BioReliance

Sigma-Aldrich has completed its acquisition of BioReliance from Avista Capital Partners for $350m. BioReliance's services will be folded into Sigma-Aldrich's SAFC custom manufacturing and services business unit.
Maryland Daily Record

Tuesday, 31 January 2012

Indian manufacturing pact for DSM

Mumbai, India-based Indoco Remedies will manufacture eight APIs for DSM's pharmaceutical products business unit. DSM said the alliance will leverage Indoco's product development and cGMP manufacturing capabilities and DSM's market access. Additionally DSM said the deal fits with its global expansion plans.
Hindu Business Line

Cambrex will begin supplying commercial quantities of sufentanil and sufentanil citrate in February


Cambrex

Pharmaceutics International has started construction of its 2,400m2 cGMP aseptic fill/finish manufacturing facility in Hunt Valley, MD


PII

Ampac Fine Chemicals Rancho Cordova, CA, facility has been granted registration to manufacture Schedule II controlled substances


Pharmaceutical Business Review

Wednesday, 25 January 2012

Lonza results miss estimates, fires CEO

Lonza has reported its full year 2011 revenues before the Arch acquisition of CHF2.5m, up 5% in constant exchange rates, missing analyst estimates. The company also announced that its CEO, Stefan Borgas, would be leaving the company with immediate effect. Lonza's share price fell 13% on the day the results were announced. Lonza said its custom manufacturing continued to benefit from demand for outsourcing from pharmaceutical and biotech companies. The company said its capacity utilisation rate for small molecules was 78% and for biological molecules was 87% excluding the recently opened Singapore facility and it had increased the number of contracts it had signed.
Outsourcing Pharma

Strong year for Albemarle

Albemare reported a strong Q4 and full year 2011 for its fine chemistry business unit. Sales in Q4 rose 36% to $209m and income 62% to $43m. For the full year the unit reported record sales of$750m up 32% and income doubles to $140m. The company said that the unit is set for another strong year in 2012.
Seeking Alpha

Thursday, 19 January 2012

Dishman is planning to sell its Chinese API manufacturing facility in Shanghai


Wall Street Journal

Avecia Biotechnology plans acquisition

Avecia Biotechnology has identified a possible acquisition target that would expand its capabilities. Company President Detlef Rethage said it has chosen a company in the fill and finish business. Avecia has not indicated when the acquisition would be completed.
Mass High Tech

AMRI UK site receives GMP certificate

AMRI’s Holywell, UK, manufacturing facility has received a GMP certificate following an inspection in October 2011. The site also passes a US FDA audit in June 2011. AMRI said the former Excelsyn facility can now produce registered intermediates and active ingredients for use in humans and expands the range of projects that it can now conduct at this facility.
AMRI

Tuesday, 17 January 2012

Scil Proteins will manufacture Actavis's recombinant protein, Reteplase


Pharmaceutical Business Review

Almac will manufacture MGB Biopharma's gram positive antibacterial compound, MGB-BP3


Manufacturing Chemist

Molecular Profiles to expand cGMP capacity

Molecular Profiles is adding a new £9m manufacturing facility at its Nottingham, UK, site. The new facility, which is due to open later this year, will add 3000m2 of space and provide six new GMP suites, new laboratories and a clinical packing suite. It is designed to enable flexibility of use and the manufacture of highly potent compounds up to OEB 4 level.
InPharm

Carbogen Amcis acquires Creapharm

Dishman Pharmaceuticals subsidiary Carbogen Amcis has acquired Creapharm Parenterals for an undisclosed sum. The business, which will be renamed Carbogen Amcis SAS, adds complimentary formulation and lyophilisation services as well as sterile GMP-standard capabilities for the rapid supply of medicines, including highly potent compounds for preclinical and clinical trials to Carbogen Amcis.
Pharma Times

Tuesday, 10 January 2012

Pfenex will develop production strains and fermentation process conditions and supply bulk protein to ProZyme for use in research and diagnostics


Pfenex

Future of AMRI's Hungary facility in doubt

AMRI is considering options for its custom research and manufacturing facility in Budapest, Hungary. The company said the site had been losing money over the last two years and the company is considering transferring the activities to other sites.
Outsourcing Pharma

Angel Biotechnology's revenue for the year ended 31 December 2011 was £3.06m


Business7

Wednesday, 28 December 2011

AMRI restructures for 2012

AMRI is to take additional actions to streamline its operations in 2012. During Q4 2011 AMRI has reduced its workforce, reduced capacity and reduced operating costs. The company hopes these actions "will better align the business to current and expected market conditions and are expected to improve the company’s overall cost competitiveness and increase cash flow generation". AMRI said the reduction will primarily affect its US operations and will terminate the lease of one of its US facilities. AMRI expects that these cost-reduction initiatives will result save $10-11m per year.
Times Union

Angel Biotechnology has raised £1.15m through a placing of new shares


The Scotsman

Sunday, 18 December 2011

Cambrex's manufacturing site in Charles City, Iowa, has received a GMP certificate from the UK's Medicines and Healthcare products Regulatory Agency


Cambrex

Angel Biotechnology has signed a Framework Agreement to develop, scale up and manufacture a recombinant protein product for TransGenRx


RTT News

GE and M+W to build biopharma manufacturing plants

GE Healthcare and M+W Group have formed a partnership to offer an integrated, "turn-key" approach for the construction of biopharmaceutical manufacturing plants, to help meet the rapidly increasing worldwide demand for these potentially life-saving treatments. The alliance is targeted at emerging countries.
Bloomberg BusinessWeek

Lonza expands early phase manufacturing in China

Lonza has completed the expansion of it snarly phase manufacturing capacity in Nansha, China. Lonza has added a new cGMP kilo-lab and an additional small scale train to meet the growing demands of its global small molecule customers.
Manufacturing Chemist

Tuesday, 13 December 2011

DSM Pharmaceutical Products will manufacture and supply QRxPharma's MoxDuo morphine and oxycodone capsules for the US market through 2015


PR Newswire

EMA and FDA to collaborate on GMP inspections

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are to share work on inspections of manufacturing sites in each other's territories, starting in January 2012. The initiative builds on a pilot programme which ran earlier this year. Initially the programme will focus on inspections of manufacturing sites in the EU or US that are already known to the two authorities and have a history of compliance with GMP following previous inspections.
InPharm

Australian biologics facility moves closer

DSM Biologics and the University of Queensland’s Australian Institute for Bioengineering and Nanotechnology (AIBN) have signed a memorandum of understanding to construct and run Australia’s largest biologics scale-up facility in Brisbane. The Aus$65m facility, which is currently under construction, will be owned by Biopharmaceuticals Australia and will be run by DSM Biologics. The AIBN will collaborate on early stage biologics development.
Australian Life Scientist

Lonza is one of a number of companies receiving a share of £8.5m to address challenges in the development of cell based medicines


PM Live

IMCD has acquired Organotec


In-pharma Technologist

Wednesday, 7 December 2011

Novasep restructures balance sheet

Novasep has completed a restructuring of its balance sheet with its creditors. Additionally the French Fonds Stratégigue d’Investissement (French Strategic Investment Fund) has become a new investor in the company, which as abandoned its plans to merge with Minakem.
Speciality Chemicals

A UK court has found for Albemarle in a case against AstraZeneca regarding a clause in a supply agreement


Supply Management

Tuesday, 6 December 2011

Shasun aims for growth

Shasun Pharmaceuticals Managing Director S Abhaya Kumar has said the company aims to double its annual revenues to $389m, within four years, by increasing exports. The company is currently adding new API manufacturing capacity in Vizag, India, and expanding capacity in Newcastle, UK.
Economic Times

Thursday, 1 December 2011

Vivimed acquires Uquifa

Vivimed Labs has acquired Yule Catto's Uquifa pharmaceutical ingredients business for £35m. Uquifa operates three manufacturing sites, two in Spain and one in Mexico. Mark Robbins will remain CEO of Uquifa. Vivimed said the acquisition would strengthen its current position in pharma APIs and intermediates while significantly improving the cost competitiveness of Uquifa.
Economic Times

Lonza will manufacture the API for Elan's ELND005


Pharmaceutical Business Review

Wednesday, 30 November 2011

Sales fall at Dottikon

Dottikon reported H1 sales fell by 14% year-on-year to CHF30.8m and a net loss of CHF2.7m. The company said it had reached its "prospective bottom" and had ended short hours working.
Dottikon

Thursday, 24 November 2011

Strong sales for Johnson Matthey

Johnson Matthey's Fine Chemicals division reported sales 16% higher at £142m in the six months ended 30 September. The company said its return on sales fell slightly as a result of the impact of a restructuring programme at Macfarlan Smith. Johnson Matthey is planning to use its Conshohocken, US, facility to manufacture intermediates and final products at lower cost and higher efficiency, enabling the company to rationalise global production and secure new business which could not have been targeted previously.
Johnson Matthey

Tuesday, 22 November 2011

OctoPlus will manufacture an additional drug product for an existing customer


OctoPlus

SAFC has commenced conformity testing for the manufacturing process for Oncolytics Biotech's Reolysin


Oncolytics Biotech

Aesica opens potent products plant

Aesica has opened its £3m manufacturing facility for potent products in Queenborough, Kent, UK. Aesica said the new facility will significantly enhance and extend its capabilities in terms of formulated products and the packaging of solid dosage forms. The new facility gives Aesica the capability to manufacture products classified as SafeBridge Category 3 and Schedule II controlled drugs such as opiates.
Kent Online

Thursday, 10 November 2011

UK companies receive government support

Aesica Pharmaceuticals, Piramal Healthcare and Shasun Pharma are to share £2m of funding from the UK government's Regional Growth Fund with two other companies. The companies will use the funding to expand their international activities.
News Post Leader

French fine chemicals companies Groupe Novasep and Minakem have denied rumours in Les Echos that Minakem is to acquire Novasep


Speciality Chemicals

Tuesday, 8 November 2011

Manufacturing revenues up for AMRI

AMRI reported a flat Q3 2011 with sales of $50.2m, however sales for its manufacturing services rose. AMRI's development/small-scale manufacturing revenue was up 8% to $9.2m and large-scale manufacturing revenue increased 17% to $25.7m.
AMRI

Cobra acquires Unitech

Cobra Biologics has acquired Unitech Pharma Group and its bio-production facility in Matfors, Sweden. The company said the acquisition is part of its strategy to expand its service offering. The Matfors facility will which add a 600L clinical and commercial microbial GMP production capacity, commercial aseptic fill/finish and lyophilisation capability to Cobra's portfolio.
Outsourcing Pharma

Strong Q3 sales at Cambrex

Cambrex reported that sales in Q3 2011 rose 18% to $58.2m including a 7% rise due to favourable exchange rates. The company said that higher volumes of an API for a customer who experienced a disruption in its supply chain for most of 2010, higher volumes of controlled substances, products utilising its drug delivery technology and a recently approved innovator product were the main reasons for the rise. These were partially offset by lower pricing across several product categories, lower sales of generic APIs and lower custom development shipments.
Cambrex

Tuesday, 1 November 2011

Chemie Uetikon acquired by Barclays and management

Barclays Private Equity has acquired a majority shareholding in CU Chemie Uetikon from CPH Chemie + Papier Holding AG. Barclays, which has acquired 90% of the Lahr, Germany-based company, said it and the company's management will pursue a consistent growth strategy in pharmaceuticals, cosmetics and nutrition industries.
Uetikon

Capacity utilisation up at Lonza

In its Q3 2011 business update Lonza said its underlying business appears on track to deliver growth through 2011. The company said that capacity utilisation in its pharma-facing custom manufacturing businesses remains high - about 90% for biologics and about 83% for chemicals. The company said it still faces challenges from the strength of the Swiss Franc, raw material headwinds and continued competition in life science intermediates.
Reuters

Monday, 31 October 2011

SAFC's Verona, WI, HPAPI facility has received SafeBridge certification


Contract Pharma

CMC Biologics has signed a three-year deal to provide process development support and manufacture for several clinical-stage antibodies for Daiichi Sankyo


Pharmaceutical Business Review

Fujifilm to manufacture ContraFect biologic

Fujifilm Diosynth Biotechnologies will use its pAVEway advanced protein expression technology at its Billingham, UK, facility to support the process development and cGMP manufacture of CF-301, ContraFect’s Staphylococcal-specific bacteriophage lysine.
Manufacturing Chemist

Prosonix has appointed a scientific board


Prosonix

Lonza to manufacture GenMab's HuMax-TF

Lonza will provide process development and cGMP manufacturing for Genmab’s monoclonal antibody HuMax-TF in its Slough, UK facility. The antibody, which is expressed using Lonza’s GS Gene Expression System, will be conjugated at Lonza's plant in Visp, CH to a cytotoxic drug to form the antibody drug conjugate.
GEN

Panreac has launched Panreac Pharma, to providing GMP compliant excipients and pharmacopoeia grade raw materials


Manufacturing Chemist

Abbott plans to keep its contract manufacturing operations after it spins off its research-based pharma business


Outsourcing Pharma

Monday, 24 October 2011

Almac to increase manufacturing capacity

Almac is expanding manufacturing capacity to over 30m3 at its Craigavon, UK, headquarters. The company said the facility will include reactor vessels with state of the art clean room product isolation and drying equipment to allow HPAPI manufacture up to 600kg batch size. Almac anticipates that the facility will be built, commissioned and validated within the next two years.
Almac

Layoffs at Corden

Corden Pharma Colorado, the former Roche Colorado facility recently acquired by ICIG, is to lay off 60 of its 260 workers.
Boulder County Business Report

Lonza is considering building a new research centre in Singapore


Today online

Thursday, 20 October 2011

Lonza will begin trading on the Main Board of the Singapore stock exchange on 21 October


Business Times

Almac to expand pharmaceutical development capabilities

Almac will invest £4.5m in the first phase of expanding pharmaceutical development capabilities at its headquarters in Craiavon, Northern Ireland. The new laboratory scale facility, which is due for completion in mid-2012, will provide non-GMP formulation facility for the development and scale-up of solid oral dose drug products using a range of technologies. The second stage of the expansion will add dedicated analytical laboratories before the end of 2012.
Genetic Engineering and Biotechnology News

Lonza has completed its acquisition of Arch Chemicals


Lonza

Carbogen Amcis and Polymun Scientific to team on HPAPI technologies

Carbogen Amcis will collaborate with Polymun Scientific to offer additional services for the development, manufacturing and formulation of HPAPIs. Carbogen Amcis will gain access to Polymun's innovative liposome technology for the formulation of APIs and Polymun will have access to Carbogen Amcis' expertise in the development and manufacture of highly potent APIs.
Carbogen Amcis

Wednesday, 19 October 2011

Hovione collaborates with Bend Research

Hovione and Bend Research will collaborate to offer their clients access to each other's capabilities. Bend Research will offer its clients access to Hovione’s commercial-scale pharmaceutical manufacturing facilities and Hovione clients will have access to Bend Research’s oral drug-delivery, formulation, and engineering expertise.
Bend Research

Monday, 17 October 2011

Lonza has successfully completed its tender offer for Arch Chemicals


Lonza

Angel to establish jv

Angel Biotechnology is to establish a joint venture with Materia Medica Holding (MMH). The jv, which will be 51% owned by MMH and 49% owned by Angel, will commission new product programmes and manage their production in a dedicated GMP unit operated by Angel, on behalf of MMH. To manufacture products for MMH, Angel plans to increase the size of the GMP facility at Cramlington.
Proactive Investors

Profits fall at Aesica

Aesica's pre-tax profit in 2010 fell from £9.7m to £3.4m as sales fell slightly from £84.6m to £83.5m. The company said the closure of its Ponders End facility in London generated exceptional costs of £6.8m, including £3.1m primarily relating to redundancy payments.
Insider Media, Yorkshire

Aesica has entered a long-term strategic partnership with Mitovie Pharma to provide clinical trial and commercial batch supply and formulation development services


Aesica

Saltigo to add HPAPI manufacturing capabilities

Saltigo is adding the capabilities to produce potent and highly potent APIs at its Redmond, WA, facility. Andreas Stolle, head of Saltigo's pharma business line, said the kilogram scale facility, aimed at supplying materials for phase I and II, will be available early in 2012. Additionally, Saltigo's Leverkusen site has been accredited by the Japanese Pharmaceuticals and Medical Devices Agency.
Saltigo

Wednesday, 5 October 2011

Aesica will manufacture codeine for Noramco


Aesica

Carbogen Amcis completes inspection

Carbogen Amcis has successfully completed a US FDA pre-approval inspection for a new high potency drug. for a US multinational. Dishman's managing director JR Vyas said: "Post this approval, we expect business of around $10m per annum from our existing customers."
Money Control

Aesica gets new investor plans expansion

Silverfleet Capital has replaced LDC as the majority investor in Aesica. Silverfleet's investment will enable Aesica to continue its rapid expansion into new markets and achieve its vision of becoming the number one supplier of APIs and formulated products to the global pharmaceutical industry.
Contract Pharma

Cambridge Major's Weert, Netherlands, facility has been approved by Dutch authorities


Outsourcing Pharma

The FDA has informed AMRI that the corrective actions underway at its Burlington, MA, facility, should address its investigator's observations


AMRI

Lonza will provide clinical and long-term commercial production of Mesoblast’s allogeneic adult stem cell products


Lonza

Novasep will manufacture eicosapentaenoic acid for Photonz Corporation


Scoop

CMC Biologics unveiled a $10m addition to its Bothell, WA, manufacturing plant


Everett Daily Herald