Pharmaceutical manufacturing: news in brief
pharmafile | July 22, 2009 | News story | Manufacturing and Production |Â Â GWÂ
Pharmafocus presents a round-up of developments in manufacturing, including facility updates from GW and Viva Biopharm, GMP problems at an Apotex plant and a string of product recalls in the US.
GW Pharmaceuticals will now be able to manufacture its Sativex product for multiple sclerosis-related spasticity in-house, having passed an inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its production plant. Up to now GW has sub-contracted the final step in the bulk manufacture of Sativex to a contract manufacturer. The approval sets the firm up for the anticipated European commercial launch of Sativex, expected sometime next year.
Canadian generic pharmaceutical firm Apotex is the latest company to fall foul of the US Food and Drug Administration's inspectors and is facing an import ban on its products. A warning letter sent to the firm last month details a number of problems at Apotex' facility in Ontario, including a lack of process controls which raise concerns about its ability to "consistently manufacture drug products meeting predetermined specifications".
Wyeth has been forced to recall one lot of its pneumococcal vaccine Prevnar in the US, after it was discovered that bulk pre-filled syringes that were not intended for commercial use got mixed in with commercial product. The company said it had investigated the case and there is no health or safety risk to patients, and no need to revaccinate.
Teva Pharmaceuticals of Israel has said that the vial of the anaesthetic propofol found at the home of singer Michael Jackson does not belong to either of two batches recalled in the US because of bacterial contamination. Teva issued the recall for more than 57,000 10mg vials of the anaesthetic on July 16 after receiving reports of adverse health effects suggesting exposure to bacterial endotoxin among 41 users of the product.
Ranbaxy has withdrawn a batch of its acne drug Sotret (isotretinoin) from the US market after samples failed dissolution testing that was carried out by FDA. The product is one of 30 Ranbaxy's products that are under an import ban because of manufacturing problems at facilities operated by the company in India. Ranbaxy, a subsidiary of Japan's Daiichi Sankyo, was permitted to sell goods already in the US supply chain at the time the ban was implemented.
Construction of a new manufacturing facility for US drugmaker Viva Biopharm USA has started in Blaine, Washington state. The 200,000 sq. ft. unit will cost around $30 million to build and should come online in 2011, according to the firm, which is a subsidiary of Canadian generic and over-the- counter medicines manufacturer Viva Pharmaceutical.
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