GLAND : RECEIVES USFDA APPROVAL FOR METHYLPREDNISOLONE ACETATE INJECTION

• USFDA approval for ANDA of Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL and 80 mg/mL single-dose vials • Also covers multiple-dose vials of 200 mg/5 mL, 400 mg/10 mL (40 mg/mL) and 400 mg/5 mL (80 mg/mL) • Product is bioequivalent and therapeutically equivalent to Pfizer's Depo-Medrol Injectable Suspension • Indicated across allergic, dermatologic, endocrine, gastrointestinal, hematologic, neoplastic, nervous system, ophthalmic, renal, respiratory and rheumatic disorders • IQVIA pegs US sales of methylprednisolone injection at ~USD 214 million for 12 months ending August 2026

Gland Pharma Limited

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