Caplin Steriles Receives USFDA Approval for Methylprednisolone ANDA
Filing Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Ltd, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Methylprednisolone Acetate Injectable Suspension USP. This approval covers 40mg/mL and 80mg/mL single-dose vials, which are generic equivalents of Pfizer Inc.’s DEPO-MEDROL. The product had US sales of approximately $57 million for the year ending November 2025. This development marks a significant milestone for Caplin Steriles in expanding its product offerings in the US market.
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Ltd, has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Methylprednisolone Acetate Injectable Suspension USP. The approval pertains to 40mg/mL and 80mg/mL single-dose vials, which are generic therapeutic equivalents of the Reference Listed Drug (RLD) DEPO-MEDROL from Pfizer Inc., USA.
The US sales for Methylprednisolone Acetate Injectable Suspension USP, 40mg/mL and 80mg/mL single-dose vials, were approximately $57 million for the 12-month period ending November 2025, according to IQVIATM (IMS Health). This financial data highlights the market potential for Caplin Steriles’ newly approved product in the US pharmaceutical market.
The approved product is primarily used as an anti-inflammatory treatment across various medical conditions, including allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic diseases, ophthalmic diseases, respiratory diseases, and rheumatic disorders. The approval allows Caplin Steriles to offer a cost-effective alternative to the existing branded product, expanding its portfolio in the US market.
Caplin Steriles Limited has developed and filed 53 ANDAs in the USA, with 50 approvals to date, including acquired ANDAs. The company is working on a portfolio of over 55 injectable and ophthalmic products for future filings. Caplin Steriles also holds multiple product approvals in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, South Africa, and Saudi Arabia.
The approval from the USFDA represents a significant milestone for Caplin Steriles in its strategic efforts to expand its presence in the US market. The company continues to focus on developing and filing new products to enhance its market offerings and meet regulatory standards.
Caplin Point Laboratories Ltd is a pharmaceutical company with a unique business model targeting emerging markets in Latin America and Africa. The company operates state-of-the-art manufacturing facilities that produce a wide range of finished dosage forms. Caplin Point has consistently demonstrated growth in cash flows, profitability, and revenues over the past 15 years, and has been recognized on Forbes’ “Asia’s 200 Best Under a Billion” list multiple times.