Caplin Steriles Secures USFDA Nod for Generic DEPO-MEDROL Injection
Chennai: Caplin Steriles Limited, a wholly owned subsidiary of Caplin Point Laboratories Limited, has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL and 80 mg/mL, in single-dose vials.
The approved product is a generic therapeutic equivalent of the Reference Listed Drug (RLD) DEPO-MEDROL by Pfizer Inc., USA.
Methylprednisolone Acetate Injectable Suspension is a corticosteroid primarily used as an anti-inflammatory treatment across a wide range of conditions, including allergic states, dermatologic disorders, endocrine and gastrointestinal diseases, hematologic and ophthalmic conditions, respiratory illnesses, and rheumatic disorders.
According to IQVIA (IMS Health) data, the US market for Methylprednisolone Acetate Injectable Suspension USP 40 mg/mL and 80 mg/mL recorded sales of approximately USD 57.4 million for the 12-month period ending November 2025.
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With this approval, Caplin Steriles continues to strengthen its regulated-market portfolio. The company has filed 53 ANDAs in the United States, either independently or with partners, and has received 50 approvals so far, including acquired ANDAs. It is also working on a pipeline of over 55 simple and complex injectable and ophthalmic products planned for filing over the next four years.
Caplin Steriles’ facilities are approved by multiple regulatory authorities including the USFDA, EU-GMP, ANVISA, and INVIMA. Its parent company, Caplin Point Laboratories, focuses primarily on emerging markets in Latin America and Africa and has maintained consistent growth in revenues and profitability over the past 15 years.
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