Consistency Evaluation of Pantoprazole Sodium for Injection (NCPC) Approved

An "Approval Notice on Drug Supplementary Application” was issued by the National Medical Products Administration (NMPA) to Pantoprazole Sodium for Injection (40 mg) manufactured by North China Pharmaceutical Co., Ltd. (NCPC), which means the generic drugs consistency evaluation of the quality and efficacy of the product was approved.

Pantoprazole Sodium for Injection is indicated for treatment of duodenal ulcers, gastric ulcers, acute gastric mucosal lesions, compound gastric ulcers and other acute upper gastrointestinal bleeding. It is a proton pump inhibitor that inhibits gastric acid production by covalently binding to two sites of the H-K-ATPase system in gastric parietal cells. It inhibits gastric acid secretion in both basal and stimulated states and the inhibitory effect is dose-dependent.

Pantoprazole Sodium for Injection is a key digestive and metabolic product of NCPC. Two sets of freeze-drying systems, GEA and IMA, as well as various advanced equipment such as Morimatsu Liquid Preparation, BREVETTI fully automatic light inspection, IWK automatic packaging, and GEA fully sealed automatic feeding and discharging system are equipped for its manufacturing system and the impact of manual operation on sterility has completely solved. It was demonstrated that the self-developed formulation is consistent with the reference product in quality and efficacy through 2 years and 9 months of joint cooperation between all departments and the production unit in NCPC and overcoming various difficulties such as epidemic prevention and control of COVID-19.  Pantoprazole Sodium for Injection has been reviewed and approved. Adhering to strict quality control, NCPC will pursue higher product quality, ensure product supply and strive to provide high-quality and affordable drug products for the people.