On August 5th, Gelunhui reported that Humanwell Healthcare (600079.SH) announced that its holding subsidiary, Yichang Humanwell, recently received the GMP certificate with the number "UKGMP48442InspGMP48442/33381169-0003" from the UK Drug and Health Product Management Bureau (MHRA). The production line involved in this certification is the final sterilization small-volume injection production line at Yichang Humanwell's global headquarters base at 517 Donglin Road, Yichang City. The annual designed production capacity is 0.5 billion small-volume injections. It passed the MHRA's GMP (Good Manufacturing Practice) compliance inspection in October 2023, with a total investment of about CNY 0.5 billion. The main products currently produced on this production line are fentanyl citrate injection and sufentanil citrate injection. Yichang Humanwell's fentanyl citrate injection achieved sales revenue of approximately CNY 65 million in 2023, while the sufentanil citrate injection achieved sales revenue of approximately CNY 1.8 billion in 2023.
As of now, Yichang Humanwell's overseas business accounts for no more than 10% of its total revenue, and the products related to the final sterilization small-volume injection production line have not yet been sold in the UK. This certification of Yichang Humanwell's final sterilization small-volume injection production line complying with the UK GMP standards marks the recognition and affirmation of the UK regulatory market for Yichang Humanwell's production system, and will have a positive impact on its expansion into the UK generic drug market.