Chennai, Feb 05, 2025 – Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited (BSE: 524742, NSE: CAPLIPOINT), has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Procainamide Hydrochloride Injection USP in 1g/10mL and 1g/2mL Vials. This product is a generic therapeutic equivalent to the Reference Listed Drug (RLD) PRONESTYL, originally from Apothecon Inc.
Key Highlights
- Drug Approved: Procainamide Hydrochloride Injection USP.
- Dosage Forms: 1g/10mL and 1g/2mL Vials.
- Market Equivalent: Generic version of PRONESTYL (Apothecon Inc.).
- Therapeutic Use: Treatment for arrhythmia (abnormal heart rhythm).
- Market Data: According to industry estimates, the drug had U.S. sales of approximately $20 million in the 12-month period ending December 2024.
About Caplin Steriles Limited
Caplin Steriles is an emerging leader in sterile product manufacturing, with regulatory approvals from US FDA, EU-GMP, ANVISA, and INVIMA. The company has:- Developed and filed 46 ANDAs in the U.S., with 33 approvals so far.
- Plans to file over 40 additional injectable and ophthalmic products within the next four years.
- Multiple product filings and approvals across Mexico, Australia, Canada, and South Africa.
Caplin Point Laboratories: A Growth-Oriented Pharma Player
Caplin Point Laboratories is a high-growth pharmaceutical company focused on Latin America and Africa. Key achievements include:- Strong cash flow, profitability, and revenue growth over the last 15 years.
- Featured seven times in the last ten years on Forbes’ Asia’s 200 Best Under a Billion list.
- Recognized with the Emerging Company of 2018 and Business Excellence Award for 2019 by Economic Times.
