King-Friend subsidiary gains FDA approval for vecuronium bromide production site

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. announced that its subsidiary, Meitheal Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for an additional production site for vecuronium bromide for injection. This approval, under ANDA No. 074688, allows for the manufacture of the 10 mg/vial and 20 mg/vial dosages at Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.'s facility. This new approval enables the product to be sold in the United States, which is expected to positively impact the company's operating performance.

Vecuronium bromide for injection is indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. The company invested approximately 2,423,800 yuan in the research and development of this product.

Currently, eight other companies, including EUGIA PHARMA, GLAND, HIKMA, and HOSPIRA, have received approval for vecuronium bromide for injection in the US. While the new approval is promising, the company emphasizes careful risk management, as product sales and production can be influenced by national policies and market conditions.