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 in 40mg/mL and 80mg/mL strengths. The approval covers single-dose vials and marks a key regulatory clearance for the company in the regulated US injectable market.
The approved product is a generic therapeutic equivalent of the reference listed drug DEPO-MEDROL, originally developed by Pfizer Inc.. Methylprednisolone Acetate Injectable Suspension is widely prescribed as an anti-inflammatory therapy and is used across a broad range of medical conditions, including allergic reactions, dermatological disorders, endocrine disorders, gastrointestinal diseases, hematologic conditions, ophthalmic issues, respiratory diseases, and rheumatic disorders.
The US market opportunity for this formulation remains meaningful. As per IQVIA™ (IMS Health) data, Methylprednisolone Acetate Injectable Suspension USP in 40mg/mL and 80mg/mL single-dose vials recorded sales of approximately $57.4 million in the United States during the 12-month period ended November 2025. This provides a reasonable addressable market size for approved generic players, subject to competition and pricing dynamics.
