Gland Pharma Gets USFDA Nod for Methylprednisolone Injectable

Gland Pharma Limited has received 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 covers 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). This product is bioequivalent to Pfizer Inc.'s Depo-Medrol Injectable Suspension and is indicated for a wide range of medical conditions including allergic states, dermatologic diseases, and rheumatic disorders. The US market for Methylprednisolone injection was approximately USD 214 million for the twelve months ending August 2026, according to IQVIA.