Anglo-Chinese joint venture makes first API batches
pharmafile | April 26, 2011 | News story | Manufacturing and Production |Â Â China, Hebei Aoxing Pharmaceutical, Macfarlan Smith, manufacturing and productionÂ
China’s Hebei Aoxing Pharmaceutical has passed a major milestone in its joint venture with process technology specialist Macfarlan Smith to make active pharmaceutical ingredients (APIs).
The JV, called Hebei Aoxing API Pharmaceutical, was set up in 2010 and eventually plans to develop a portfolio of eight APIs at its facility in Xinle City, China, using process technology supplied by Macfarlan Smith, a subsidiary of UK chemical firm Johnson Matthey.
The two partners said three batches of their first API – naloxone hydrochloride – had been produced using the new process, at low cost, and had met both European and Chinese pharmacopoeia specifications. Naloxone is used to counter the effects of overdosing with opiate drugs such as heroin or morphine overdose.
Hebei Aoxing is a subsidiary of Aoxing Pharmaceutical Co, a specialty drugmaker focusing on narcotics and pain management products. Given the parent company’s expertise the initial plan is to sell naloxone hydrochloride and seven other opioid APIs in the Chinese market, although in time the product portfolio could be diversified with more than 30 APIs.
The Chinese partner has contributed capital, fixed assets and API manufacturing licenses to the partnership, while Macfarlan Smith is bringing its technology expertise as well as capital funding. The investment by both parties has been estimated at around $15 million over five years, and the JV is 51%-owened by Hebei Aoxing and 49% by Macfarlan Smith.
During a visit to the Xinle City facility last month, John Fowler, president of Johnson Matthey Pharmaceutical Materials & Services, and Roger Kilburn, managing director of Johnson Matthey Pharmaceuticals, said they were pleased with the progress made.
The next step would be to get the plant GMP-certified and the adoption of Macfarlan Smith’s process technology approved by China’s State Food and Drug Administration.
“With the success to date of the first product, naloxone hydrochloride, we are excited to see the JV partners work closely on other API’s moving forward”, Fowler and Kilburn commented.
Phil Taylor
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