Hebei Aoxing is a joint venture between China-based Aoxing and Macfarlan Smith, a subsidiary of Johnson Matthey. Production of the new active pharmaceutical ingredient (API), which will meet European and Chinese standards, was made possible by technology from Macfarlan Smith.
President of Johnson Matthey, John Fowler, and managing director Roger Kilburn visited the manufacturing facility in Xinlei City, China, earlier this month. The pair said securing good manufacturing practice (GMP) certification remained a priority.
“We are highly encouraged by and satisfied with the joint venture’s progress following our recent visit to the facility and meeting with the technical personnel involved,” they said in a joint statement.
“We look forward to seeing the joint venture apply for GMP certification and approval of the process change to Macfarlan Smith’s technology by the SFDA [China’s food and drug administration]. With the success to date of the first product, naloxone hydrochloride, we are excited to see the joint venture partners work closely on other API’s moving forward.”
Naloxone hydrochloride represents the first commercial opportunity for the joint venture, which is initially focusing on eight API products. The company claims the next step is to apply for GMP certification of its workshops and approval of the process change.
Zhenjiang Yue, chairman and CEO of Aoxing, said all parties had worked hard to ensure the transfer of new equipment went smoothly, adding that it had already been put to use.
“Under the guidance of Macfarlan Smith technologists, the joint venture has completed the synthesis of three batches of naloxone hydrochloride. This was accomplished at low cost with a quality meeting both European and Chinese pharmacopeia reference standards,” he said.
Yue went on to suggest that the two companies had achieved a great deal in the short time they had been collaborating.
“Since we signed the agreement with Macfarlan Smith, the joint venture has received its foreign investment authorisation certificate, manufacturing license, and business license and met all legal requirements,” he said.