Gland Pharma Limited, the Hyderabad-based generic injectables maker, said on 3 November 2026 that the US Food and Drug Administration (USFDA) has approved its Abbreviated New Drug Application (ANDA) for Methylprednisolone Acetate Injectable Suspension USP. The corticosteroid injection is a generic equivalent of Pfizer’s Depo-Medrol and addresses a US market worth about USD 214 million a year.

The approval adds another sterile product to a portfolio that already includes the company’s earlier USFDA approval for latanoprost ophthalmic solution, and it underlines how Indian manufacturers keep building share in complex US hospital injectables.

What the USFDA approval covers

According to the company’s stock exchange filing, the approval spans both single-dose and multiple-dose vial presentations:

• Single-dose vials in 40 mg/mL and 80 mg/mL strengths.
• Multiple-dose vials of 200 mg/5 mL (40 mg/mL), 400 mg/10 mL (40 mg/mL) and 400 mg/5 mL (80 mg/mL).
• Bioequivalent and therapeutically equivalent to the reference listed drug, Depo-Medrol Injectable Suspension from Pfizer Inc.

Methylprednisolone acetate is a long-acting corticosteroid. The approved label covers allergic states, dermatologic, endocrine, gastrointestinal, hematologic, neoplastic, nervous system, ophthalmic, renal, respiratory and rheumatic disorders, which makes it a routine product in hospital and clinic formularies.

How big is the US methylprednisolone injection market?

Citing IQVIA data, Gland Pharma said methylprednisolone injection recorded US sales of approximately USD 214 million in the twelve months ending August 2026. The company did not disclose a launch date. Injectable suspensions also call for tight control of particle size and uniformity across every vial during sterile manufacturing.

Why it matters for India’s sterile injectables industry

Founded in 1978 in Hyderabad, Gland Pharma began as a contract manufacturer of small-volume liquid parenterals and now sells vials, ampoules, pre-filled syringes, lyophilised products, infusions and oncology and ophthalmic solutions in about 60 countries, mainly through a business-to-business model. It also pioneered heparin technology in India.

The approval comes as Indian sterile manufacturing sites face closer regulatory scrutiny and also win clean outcomes, such as OneSource’s Bengaluru sterile plant receiving USFDA VAI status this week. Peers are expanding too, from Biophore’s sterile injectable expansion in Indore to Glenmark’s generic sugammadex injection launch in the US.

Key takeaways

• Gland Pharma won USFDA ANDA approval for generic Methylprednisolone Acetate Injectable Suspension USP on 3 November 2026.
• The product is equivalent to Pfizer’s Depo-Medrol and covers five single-dose and multiple-dose vial presentations.
• The US market for the injection is about USD 214 million a year, according to IQVIA.

FAQ

What did Gland Pharma get approved?

The USFDA approved Gland Pharma’s ANDA for Methylprednisolone Acetate Injectable Suspension USP in 40 mg/mL and 80 mg/mL single-dose and multiple-dose vials.

Which branded drug is it a generic of?

It is bioequivalent and therapeutically equivalent to Depo-Medrol Injectable Suspension, marketed by Pfizer Inc.

Featured image: Sterile manufacturing line at a Gland Pharma facility. Photo: Gland Pharma (company website)

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