Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Procainamide Hydrochloride Injection USP (1g/10mL and 1g/2mL Vials). This product is a generic equivalent of PRONESTYL by Apothecon Inc.
Procainamide Hydrochloride Injection is a key antiarrhythmic medication used to treat irregular heart rhythms by blocking abnormal electrical signals in the heart. According to IQVIA™ (IMS Health), the drug recorded US sales of approximately $20 million in the 12 months ending December 2024.
About Caplin Steriles Limited
Caplin Steriles is a rapidly growing sterile product manufacturer, approved by major regulatory agencies including USFDA, EU-GMP, ANVISA, and INVIMA. The company has developed and filed 46 ANDAs in the US, with 33 approvals to date. It is also expanding into injectable and ophthalmic products across multiple global markets, including Mexico, Canada, Australia, and South Africa.
About Caplin Point Laboratories Limited
Caplin Point Laboratories is a leading pharmaceutical company focused on emerging markets in Latin America and Africa. With state-of-the-art manufacturing facilities, the company has consistently delivered strong cash flow, profitability, and revenue growth over the last 15 years.
With this latest USFDA approval, Caplin Steriles continues to strengthen its position in the global pharmaceutical industry.