Pharma manufacturing news in brief

pharmafile | August 3, 2010 | News story | Manufacturing and Production ATMI, CMC Biologics, Cody Laboratories, Colorcon, Farmar, GE Healthcare, ProtAffin 

Excipient specialist Colorcon buys an Indian rival, FDA gets tough on unapproved drugs plus facility updates from Farmar, ATMI and GE Healthcare.

Colorcon has acquired India’s Pharmaceutical Coatings, bringing in a new product portfolio as well as a manufacturing facility in Goa that is currently under construction. The acquisition adds to Colorcon’s existing range of tablet film coatings for pharmaceutical solid oral dose development, including Tabcoat TC, an organic, hydro-alcoholic, or aqueous solvent system that can be adjusted according to the nature of the active ingredient in the formulation.

Cody Laboratories of the USA has failed in a last-ditch legal attempt to stave off an enforcement action by the US Food and Drug Administration (FDA) that could see its injectable morphine product taken off the market. The FDA’s action is part of a crackdown on unapproved drugs. Last year the agency gave manufacturers of unapproved products – including ‘grandfathered’ drugs, i.e. those placed on the market before the FDA was formed in 1938 – a time limit of 180 days to file for approval.

Germany’s Farmar GmbH has said it plans to construct a manufacturing plant for disposable syringes in the Omsk region of Siberia, Russia. The medical device specialist says it wants to build a facility with a capacity of 150 million syringes a year.

ATMI, a US manufacturer of disposable bioreactors and other equipment for manufacturing biologics, has completed a two-year, multi-million dollar expansion of its manufacturing facility in Bloomington, Minnesota. The expansion establishes a North American hub for the production, marketing and development of ATMI’s Integrity range of single-use equipment, to complement its existing production facility in Belgium.

GE Healthcare has officially opened a $15 million manufacturing facility in Cardiff, Wales, to make life sciences products used in the pharmaceutical, food and environmental industries, including separation equipment and reagents and kits used in stem cell therapy and disease diagnosis and treatment.

German biopharmaceutical company ProtAffin AG has signed up CMC Biologics as the contract manufacturer of its lead product PA401 for the treatment of chronic obstructive pulmonary disease (COPD). The contract will cover the manufacture and supply of PA401 for preclinical development and early clinical development in COPD and related respiratory indications. PA401 is a glycan-binding decoy protein based on human chemokine IL-8.

Phil Taylor

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