Gland Pharma Receives USFDA Approval for Sugammadex Injection Vials
Hyderabad, July 29, 2026 — Gland Pharma Limited, a generic injectable and ophthalmic focused pharmaceutical company, has secured approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) pertaining to Sugammadex Injection. The product is available in 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vials.The approval allows the company to market the injectable drug, which serves as a bioequivalent and therapeutically equivalent alternative to Merck Sharp & Dohme LLC's reference listed drug (RLD), BRIDION® Injection.
Product Details and Indication
Sugammadex Injection is indicated for reversing neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in both adult and pediatric patients undergoing surgery.
Gland Pharma operates under a business-to-business (B2B) model, focusing on the development, manufacturing, and marketing of sterile injectables. The company maintains a global footprint across 60 countries, including Europe, Canada, Australia, India, and the United States, having been established in Hyderabad since 1978.
Market Performance
The product has seen strong initial market traction, with Gland Pharma successfully launching Sugammadex on Day 1 through its marketing partner.
According to data from IQVIA, US sales of the drug reached approximately USD 1.6 billion for the twelve months ending April 2026.
GLAND Stock Price Movement
Shares of Gland Pharma Limited are ascending at 11:47 AM, trading at ₹2491.6 after gaining 2.61%. The equity sustains high momentum today, having traded a volume of 391,475 shares and reaching an intraday high of ₹2499.8 from its opening low of ₹2428.7.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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