Wednesday, 28 May 2008

Jubilant Organosys has completed its acquisition of Draxis Health


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.

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.

Lonza has acquired Amaxa AG to enhance its Cell Discovery business


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.

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


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.

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


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


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.

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.

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


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.

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%


Albemarle to move HQ to Baton Rouge


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