Pharma manufacturing news in brief

pharmafile | January 4, 2011 | News story | Manufacturing and Production Affinity Life Sciences, American Regent, Caraco Pharmaceutical Laboratories, Dr Reddy's Laboratories, Dr Reddy’s Laboratories, Huanggang Chuangxin Biochemicals, Kunming Quanxin Pharmaceutical Company, R-Pharm 

An explosion at a Chinese pharma company causes five deaths, plus a round-up of product recalls, facility updates and other manufacturing news.

An explosion at a pharmaceutical facility in Kunming, China, on 30 December has left five workers dead, according to a report from the Xinhua news agency. The plant, operated by Kunming Quanxin Pharmaceutical Company, is located in a residential area and more than 1,000 people had to be evacuated soon after the blast. The incident comes less than a months after another explosion at a facility operated by Huanggang Chuangxin Biochemicals in Hubei Province resulted in four deaths and several injuries.

American Regent is conducting a US-wide recall of sodium bicarbonate and dexamethasone sodium phosphate injection products because some vials have been found to contain particulate matter. The recall covers unexpired lots of sodium bicarbonate injection in 7.5% and 8.4% 50ml single dose vials, and dexamethasone sodium phosphate injection in 4mg/ml, 30ml multiple dose vials. “This voluntary recall was initiated because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates,” said the FDA.

Caraco Pharmaceutical Laboratories has lost a long-term license to distribute two of Indian drugmaker Sun Pharmaceutical Industries’ pharmaceutical products in the US with combined annual sales of around $210 million in fiscal 2010, accounting for 90% of Sun’s total net sales. From 28 January 2012, these two drugs will be sold by Sun and its wholly owned affiliates. Caraco, which is currently trying to overcome some serious manufacturing violation problems, said the end of the arrangement will have a “material effect” on its operations. The move comes as Caraco is considering a $43 million buyout offer by Sun, which already owns 75% of the US firm.

Indian drugmaker Dr Reddy’s Laboratories has joined the ranks of pharmaceutical companies targeting growth in the fast-growing Russian market via a technology transfer, manufacturing, and marketing agreement with Moscow-based firm R-Pharm. The profit-sharing agreement covers the licensing of manufacturing technology and products by Dr Reddy’s to allow local manufacturing in Russia, as well as the co-development of new products by the two companies. The announcement comes shortly after Novartis unveiled a $500 million investment programme in Russia – including the construction of a manufacturing facility – as well as a number of other investment initiatives in the country by the likes of Novo Nordisk and Sanofi-Aventis.

US contract manufacturing organisation Affinity Life Sciences has completed an expansion of its GMP-compliant facility in Milford, New Hampshire, boosting capacity for R&D, production and testing services as well as adding on-site lyophilisation capabilities. “These improvements enable Affinity to increase services for biomarker assay development and in vitro diagnostic kit production including complementary support services,” said the CMO in a statement.

Phil Taylor

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