Pharma manufacturing news in brief
pharmafile | December 7, 2010 | News story | Manufacturing and Production | A5 Laboratories, Adamis Pharmaceuticals, Beximco Pharmaceuticals, Caraco Pharmaceutical, Genethon BioProd, Jiangsu Yanshen Biological Technology, Viva Pharmaceuticals, contract manufacturing, gene therapy
Our round-up of manufacturing updates includes the world’s first dedicated gene therapy facility, hefty fines for a Chinese drugmaker plus a new facility for Viva Pharma, amongst other news.
Chinese company Jiangsu Yanshen Biological Technology has been fined by a court in Changzhou City for producing and selling substandard products, including human-use rabies vaccines. The fine of RMB 4.6 million (around $700,000) comes after an RMB 25.6 million penalty imposed earlier this year by the Changzhou Food and Drug Administration. The company is 52.5%-owned by generic manufacturer Simcere Pharmaceutical.
Canada’s A5 Laboratories has said its European partner has begun the production of its VI-1718 natural-source interferon product. The unidentified Institute of Microbiology will make use of A5 Labs’ production technology to make around 2,000 doses of VI-1718 with certificates of analysis in the next four weeks. The products manufactured at the institute will be sent for in-vitro and in-vivo testing to establish proof-of-concept potency according to US Pharmacopeia guidelines.
Canadian contract manufacturing organisation Viva Pharmaceuticals is planning to construct a $40 million manufacturing facility in the USA. The first phase of the development in Blaine, Washington, is for 34,000 sq.ft. of production space, 10,000 sq.ft. of storage space and 9,000 sq.ft. of office space. Viva has filed for planning permission for the development says that construction could start within weeks if approved, according to a report in local newspaper The Northern Light.
Adamis Pharmaceuticals of the USA has signed a strategic agreement with Bangladesh company Beximco Pharmaceuticals for the manufacturing, supply, and development of four allergy and asthma drugs, planned for launch in the US within the next three years. The companies will also co-develop certain other drugs for the US, some of which Beximco currently produce for European market. Adamis will be responsible for state-side regulatory approval and sales.
Sun Pharmaceutical of India is planning to delist its troubled subsidiary Caraco Pharmaceutical from the US stock exchange. The company says it plans to acquire all the outstanding Caraco shares in order to claim 100% ownership of the unit, in which it currently holds a 76% stake. The transaction is expected to cost around $49 million. Last year, US Marshals seized active pharmaceutical ingredients (APIs) and finished products with an estimated value of around $20 million from Caraco after a series of manufacturing quality violations.
A facility claimed to be the first in the world dedicated to manufacturing gene therapies is scheduled to start production next year in Evry, France. The Genethon BioProd laboratory will specialise in making medicines based on viral vectors which deliver a genetic payload into patient cells designed to correct a gene defect. The objective is to produce 20 batches a year for use in clinical trials.
Phil Taylor
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