The facility, which has been cleared by the State Food and Drug Administration (SFDA) for five years, will produce solid dose versions of narcotic painkillers like oxycodone and buprenorphine for the Chinese market.
The plant will also make the powerful narcotic pain management product tilidine, which Aoxing became one of the few manufacturers licensed to manufacture for the Chinese market in 2007.
Aoxing CEO Juan Yue Han said that the accreditation provides the foundation for the further development and strengthens the firm’s manufacturing base, positioning it for growth in China’s expanding drug market.
Since the SFDA began tightening up rules on drug production in 2006 the number of Chinese drugmakers that have gained good manufacturing practice (GMP) accreditation has increased considerably.
However, Aoxing claims that its facility is one of very few in China to have been cleared for the production of narcotic drugs, which necessarily require stricter control than other medications.
The company went on to say that the lack of manufacturing capacity, coupled with increasing demand for western pain medicines, means that the Chinese narcotic painkiller market is both “very under-served and fast-growing.”
Aoxing said it is working closely with the government and SFDA to ensure the strictly regulated availability to medical professionals of its narcotic drugs and pain medicines throughout China.
In addition, while Aoxing did not reveal any plans to make drugs for the export market, gaining GMP accreditation from the SFDA will certainly make it easier for the firm to gain similar approval from regulators outside the country in the future.