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In an exchange filing, the company said its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has been granted approval from the US health regulator for its Abbreviated New Drug Application (ANDA) Glycopyrrolate Oral Solution 1mg/5mL.
The approved ANDA is a therapeutic equivalent as well as a bioequivalent of the reference-listed drug product (RLD) of the German pharma major Merz Pharmaceuticals, LLC’s product.
The Glycopyrrolate Oral Solution is an anticholinergic medication prescribed to pediatric patients aged three to 16 years, suffering from neurological conditions associated with problem drooling, stated the company.
“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 of Granules India.
Shares of the pharma company rose 2.6% to the day’s high at ₹679.15 per piece on the BSE on Tuesday
The stock ended the day’s trade 1.77% higher at ₹673.95 per piece.
The drug maker witnessed a significant expansion in its net profit and margins during the June 2024 quarter, while its operating performance turned out to be on the stronger side too.
For the April-June period, the company’s net profit rose to ₹135 crore. In the same quarter last year, Granules India posted a net profit of ₹48 crore.
Its revenue from operations grew 19.7% on a year-on-year (YoY) basis to ₹1,179.8 crore whereas the earnings before interest, taxes, depreciation, and amortisation (EBITDA) of ₹259.2 crore in Q1 FY25 witnessed a nearly 90% YoY rise.
The EBITDA margin climbed to 22% in the reporting quarter, expanding sharply by 800 basis points (bps) from 14% in the year-ago period.
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