Gland Pharma receives Tentative Approval for Sugammadex Injection

Gland Pharma Limited, a generic injectable focused pharmaceutical company, received tentative approval from the United States Food and Drug Administration (US FDA) for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial, bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Bridion® Injection, 100 mg/mL, of Merck Sharp & Dohme Corp. (Merck Sharp & Dohme).

Sugammadex Injection is used to reverse the effects of the muscle relaxants Rocuronium Bromide and Vecuronium Bromide given to patients during surgery.

Gland Pharma will launch the product through its marketing partner on receipt of final approval.

The Sugammadex Injection, 200 mg/2 mL and 500 mg/5 mL Single-Dose Vial (RLD: Bridion®) has US sales of approximately USD 615 million for twelve months ending in April 2021, according to IQVIA.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 3851.55 as compared to the previous close of Rs. 3883.45. The total number of shares traded during the day was 5559 in over 1774 trades.

The stock hit an intraday high of Rs. 3902.35 and intraday low of 3825.00. The net turnover during the day was Rs. 21433095.00.

Shares of Gland Pharma Limited was last trading in NSE at Rs. 3850.00 as compared to the previous close of Rs. 3882.60. The total number of shares traded during the day was 80001 in over 17317 trades.

The stock hit an intraday high of Rs. 3905.60 and intraday low of 3823.60. The total traded value during the day was Rs. 308344145.50.

Source : Equity Bulls

Keywords

GlandPharma INE068V01023 GLAND Pharmaceuticals USFDA TentativeApproval SugammadexInjection