Gland Pharma Limited has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Methylprednisolone Acetate Injectable Suspension USP. The approval covers both single-dose vials (40 mg/mL and 80 mg/mL) and multiple-dose vials (200 mg/5 mL, 400 mg/10 mL, and 400 mg/5 mL).

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Medrol Injectable Suspension, 40 mg/mL and 80 mg/mL, of Pfizer.

The product is indicated for the treatment of Allergic States, Dermatologic Diseases, Endocrine Disorders, Gastrointestinal Diseases, Hematologic Disorders, Neoplastic Diseases, Nervous System, Ophthalmic Diseases, Renal Diseases, Respiratory Diseases, Rheumatic Disorders and Miscellaneous.

According to IQVIA, the Methylprednisolone injection had US sales of approximately USD 214 million for the twelve months ending August 2026.