Aoxing Pharmaceutical, a specialty pharmaceutical company engaged in researching, developing, manufacturing and distributing narcotic and pain-management products, today announced that Hebei Aoxing API Pharmaceutical Company, Ltd., the joint venture between Aoxing Pharma and Macfarlan Smith Ltd., has successfully adopted advanced process technology from Macfarlan Smith. This technology transfer will allow the joint venture to produce naloxone hydrochloride API (active pharmaceutical ingredient) at both European and Chinese pharmacopoeia specifications.
Last week, John Fowler, President at Johnson Matthey Pharmaceutical Materials & Services, and Roger Kiburn, Managing Director at Johnson Matthey Pharmaceuticals, visited the facility located in Xinle City, Hebei Province. “We are highly encouraged by and satisfied with the JV’s progress following our recent visit to the facility and meeting with the technical personnel involved. We look forward to seeing the JV apply for GMP certification and approval of the process change to Macfarlan Smith’s technology by the SFDA. 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,” they commented.
Mr. Zhenjiang Yue, Chairman and CEO of Aoxing Pharma, stated, “Since we signed the JV agreement with Macfalan Smith Ltd, the JV has received its foreign investment authorization certificate, manufacturing license, and business license and met all legal requirements. We have worked hard to ensure the successful construction of workshops and related facilities. Under the guidance of Macfarlan Smith technologists, the JV has just adopted advanced process technology from Macfarlan Smith and completed the synthesis of three batches of naloxone hydrochloride API. This was accomplished at low cost with a quality meeting both European and Chinese pharmacopeia reference standards.”
Yue continued, “We look forward to applying for GMP certification of the workshops, approval of the process change, and the development of other API products through the JV. I would particularly like to thank the technologists from Macfarlan Smith who have been so closely involved in the technology transfer and ensuring it a smooth success.”
Naloxone Hydrochloride API represents the first commercial opportunity for the joint venture, which is initially focusing on eight API products. The joint venture now has its sights set on applying for GMP certification of the workshops and approval of the process change.