Recently, the Anhui Provincial Drug Administration issued an announcement stating that Anhui Bocompounds Pharmaceutical Co., Ltd vonoprazan fumarate API has passed the pre-market GMP compliance inspection.

Vonoprazan fumarate is a potassium-competitive acid blocker for the treatment of reflux esophagitis, characterized by its significant and long-lasting acid-suppressing effect. The inspection was conducted from January 21st to 23rd, 2026, covering the API production line in Area A of Workshop 203 in the Dongzhi Economic Development Zone. Based on the "Drug Administration Law of the People's Republic of China" and the "Regulations on the Supervision and Administration of Drug Production," the inspection team, through on-site verification and comprehensive evaluation, confirmed that the production line meets the requirements of Good Manufacturing Practice (GMP). This API received market approval from the National Medical Products Administration in August 2025. Passing this GMP compliance inspection signifies that it has the qualifications for compliant mass production and market supply.