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. This approval covers both single-dose and multiple-dose vials. The product is indicated for various therapeutic areas and is bioequivalent to Pfizer’s Depo-Medrol Injectable Suspension.
Gland Pharma Secures USFDA Approval for Key Injectable
Gland Pharma Limited announced today, November 3, 2026, that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA). The approval is for Methylprednisolone Acetate Injectable Suspension USP, available in both single-dose and multiple-dose vials.
Product Details and Indications
The approved product includes 40 mg/mL and 80 mg/mL Single-Dose Vials, as well as 200 mg/5 mL (40 mg/mL), 400 mg/10 mL (40 mg/mL), and 400 mg/5 mL (80 mg/mL) Multiple-Dose Vials. This injectable suspension is indicated for the treatment of a wide range of conditions, including Allergic States, Dermatologic Diseases, Endocrine Disorders, Gastrointestinal Diseases, Hematologic Disorders, Neoplastic Diseases, Nervous System disorders, Ophthalmic Diseases, Renal Diseases, Respiratory Diseases, Rheumatic Disorders, and Miscellaneous conditions.
Market Potential and Bioequivalence
The Methylprednisolone injection had US sales of approximately USD 214 million for the twelve months ending August 2026, according to IQVIA data. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Medrol Injectable Suspension, 40 mg/mL and 80 mg/mL, manufactured by Pfizer Inc. This approval represents a significant step for Gland Pharma in expanding its portfolio of injectable products in the key US market.
About Gland Pharma Limited
Established in 1978, Gland Pharma is a leading injectable-focused pharmaceutical company with a global presence across 60 countries. It operates primarily on a business-to-business (B2B) model and has a strong track record in developing, manufacturing, and marketing sterile injectables, including vials, ampoules, pre-filled syringes, and lyophilized vials. The company has also pioneered Heparin technology in India.
Source: BSE
