Granules India Limited receives ANDA approval for Glycopyrrolate Oral Solution

Granules India announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company.

It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution, 1 mg/5 mL of Merz Pharmaceuticals, LLC.

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients aged three to 16 years who have neurological conditions associated with problem drooling.

"As we strengthen Granules' footprint in the U.S. market, this approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards," said Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited.

Shares of Granules India Limited was last trading in BSE at Rs. 675.35 as compared to the previous close of Rs. 662.20. The total number of shares traded during the day was 19523 in over 1205 trades.

The stock hit an intraday high of Rs. 679.15 and intraday low of 667.70. The net turnover during the day was Rs. 13168783.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 USFDA ANDAApproval GlycopyrrolateOralSolution GranulesPharmaceuticals