Gland Pharma receives tentative approval for sugammadex injection

Gland Pharma on Friday announced that it received tentative approval from the United States Food and Drug Administration (USFDA) for sugammadex injection.

Sugammadex injection is a single-dose vial, bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Bridion Injection of Merck Sharp & Dohme Corp. The injection is used to reverse the effects of the muscle relaxants Rocuronium Bromide and Vecuronium Bromide given to patients during surgery.

According to IQVIA, sugammadex injection had US sales of approximately $615 million for twelve months ending in April 2021. Gland Pharma said it will launch the product through its marketing partner on receipt of final approval.

Shares of Gland Pharma fell 0.82% to close at Rs 3,851.55 on Friday.

Hyderabad-based Gland Pharma is one of the largest and fastest growing injectable-focused companies. It operates primarily under a business to business (B2B) model and it engaged in development, manufacturing and marketing of complex injectables. The company's net profit jumped 11.81% to Rs 350.65 crore on 30.50% increase in revenue from operations to Rs 1,153.90 crore in Q1 FY22 over Q1 FY21.

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