Caplin Steriles Secures USFDA Approval for Generic Methylprednisolone Injection
New Delhi: Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, 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, 40 mg/mL and 80 mg/mL, in single-dose vials.
The approved product is a generic version of Pfizer Inc.’s reference listed drug Depo-Medrol. Methylprednisolone Acetate Injectable Suspension is a corticosteroid indicated for its anti-inflammatory effects and is used in the management of various conditions, including allergic disorders, dermatological diseases, endocrine and gastrointestinal disorders, hematologic conditions, ophthalmic diseases, respiratory illnesses, and rheumatic disorders.
According to IQVIA™ (IMS Health) data, the reference product recorded US sales of approximately USD 57.4 million for the 12-month period ending November 2025.
Caplin Steriles is a sterile manufacturing arm of Caplin Point Laboratories and holds regulatory approvals from multiple global authorities, including the USFDA, EU-GMP, ANVISA, and INVIMA. The company has filed 53 ANDAs in the United States independently and through partnerships, with 50 approvals received to date, including acquired ANDAs.
Caplin Point Laboratories Limited operates primarily in emerging markets across Latin America and Africa, with manufacturing facilities covering a wide range of finished dosage forms. Its subsidiary, Caplin One Labs Limited, is engaged in oncology-focused injectable and ophthalmic products, with several projects at different stages of development.
