Pharma manufacturing news in brief
pharmafile | September 21, 2010 | News story | Manufacturing and Production |Â Â AAIPharma, Actavis, Japan, KV Pharmaceutical, Purac, Takeda, contract manufacturingÂ
This week’s round-up of pharmaceutical manufacturing news includes updates from Takeda, KV Pharmaceutical, Actavis, AAIPharma and Purac, while Japan’s CMOs form a trade association.
Takeda Pharmaceutical is planning to build a new manufacturing facility in Japan to serve as the flagship of its entire manufacturing network. The plant – which will be built in Hikari City in Yamaguchi prefecture – will conduct high-volume manufacturing of a wide range of Takeda’s oral dosage form products. Construction is due to start next month and the facility should be operational by April 2012.
KV Pharmaceutical has been granted approval by the FDA for a potassium chloride product in a sign that the firm’s manufacturing compliance issues may be on the way to being resolved. The US regulator placed a block on new product approvals last year after finding a number of violations in the firm’s manufacturing operations, but issued the green light after an inspection of a KV plant found significant improvements. KV’s Ethex subsidiary was fined almost $28 million last month for its role in the manufacturing problems and is to be shut down.
Some of Japan’s leading contract manufacturing organisations (CMOs) including Bushu Pharmaceuticals are setting up a trade organisation which should be officially launched in November. The Japan CMO Association is planning to develop a range of guidelines and other documents such as standardised contracts for use by CMOs and pharmaceutical manufacturers.
Generic drugmaker Actavis is investing around 12 million euros in a new warehousing unit adjacent to its manufacturing site in Bulebel, Malta. The company has invested around 50 million euros in the facility in the past six years, and it now employs more than 600 people, reports the Malta Independent.
Contract manufacturing and drug development services company AAIPharma has appointed Patrick Walsh as its new chief executive. Walsh has 30 years of pharmaceutical manufacturing experience and joins the company after stints at Kadmus Pharmaceuticals and Gensia Sicor. Lee Karras, the firm’s president who led the firm during the search for a new CEO, will remain in that role and also becomes chief operating officer.
Purac is building a 15 million-euro manufacturing facility for biomedical polymers in the US to complement its existing production capacity in the Netherlands. Construction of the facility will start in 2011 and is expected to be completed before the end of the year. Purac’s biomedical polymers are used in drug delivery and medical device applications.
Phil Taylor
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