Granules India Wins FDA Nod For Pediatric Drooling Treatment

Granules India offers pharmaceutical companies across the globe an extensive array of superior products. They are able to satisfy the various needs of their clients and guarantee that they can provide patients with safe and efficient medications because they are experts in APIs, PFIs, and FDs. Granules India is also able to maintain its leadership position in the pharmaceutical industry thanks to this specialization, as they are continuously creating new products and refining their current line to better serve their clientele. Overall, Granules India has become a dependable partner for pharmaceutical companies searching for high-quality and dependable products because of their commitment to these core areas.

Granules India has received approval for Glycopyrrolate Oral Solution:

Granules India announced today that Granules Pharmaceuticals, Inc. (GPI), the company’s wholly owned foreign subsidiary, filed the Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1 mg/5 mL and that the FDA had approved it. Granules Pharmaceuticals, Inc. (GPI), the company’s fully owned foreign subsidiary, has filed the ANDA.

Cuvposa Oral Solution (Mercz Pharmaceuticals, LLC) is a reference-listed medication with the same therapeutic and bioequivalency. Pediatric patients with neurological conditions linked to excessive drooling between the ages of three and sixteen are recommended to use Glycopyrrolate Oral Solution, an anticholinergic medication.

The chairman and managing director of Granules India, Krishna Prasad Chigurupati, stated, “This approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards as we strengthen our footprint in the U.S. market.”

Granules India Performance:

The pharmaceutical company recorded a sharply higher consolidated net profit of Rs 134.65 crore in Q1 FY25 compared to Rs 47.89 crore in Q1 FY24. The first quarter of FY25 saw a 19.72% increase in revenue from operations, amounting to Rs 1,179.87 crore, compared to Rs 985.52 crore recorded during the same period in 2024.

Granules India stock is 2% up:

Granules India Ltd. is trading at Rs. 687.50 per share today, marking a 2% increase in the intraday segment following the approval from the USFDA for the oral drug Glycopyrrolate.

Conclusion: Granules India is one of the best pharmaceutical companies, and due to their hard work and dedication, they have received approval from the USFDA for the Glycopyrrolate Oral Solution.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.