Last Updated on September 30, 2024 by The Health Master
USFDA approval
Hyderabad, India – Granules India, a leading pharmaceutical company, has announced a significant milestone with the US Food and Drug Administration approval (USFDA approval) of its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL.
This groundbreaking development marks a crucial step forward in the treatment of drooling in pediatric patients.
Addressing a Significant Unmet Need
Glycopyrrolate Oral Solution is a vital medication prescribed to children aged 3 to 16 years who grapple with excessive drooling due to neurological conditions.
The USFDA approval of Granules India’s generic version brings much-needed relief and improved treatment options to these young patients.
Generic Equivalent to Cuvposa Oral Solution
Granules Pharmaceuticals, a wholly-owned subsidiary of Granules India, successfully filed the ANDA for Glycopyrrolate Oral Solution.
The approved generic is bioequivalent and therapeutically equivalent to the brand-name drug, Cuvposa Oral Solution, manufactured by Merz Pharmaceuticals.
This equivalence ensures that patients can access an affordable and effective treatment alternative.
Expanding Granules India’s US Market Presence
The USFDA approval of Glycopyrrolate Oral Solution underscores Granules India’s commitment to providing high-quality, affordable generic medications to patients in the United States.
This achievement further solidifies the company’s position as a key player in the US pharmaceutical market.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
USFDA approval granted for blockbuster drug for Cancer treatment
USFDA approval granted for Valbenazine Capsules
USFDA approval granted for Trazodone tablets
USFDA approval granted for Acitretin Capsules USP
USFDA approval granted for drug against Baldness
Deadly Fire Ravages Pharma Company in Andhra Pradesh
USFDA inspection with positive VAI to Strides Pharma at Chennai
Indian Pharma Export 8.4 per cent growth in July
Kerala Discount Pharmacies Under Scrutiny: A Battle for Transparency and Fair Competition
Govt extends tenure of Bulk Drug Parks for one year
ICMR Announces Initiative for Evidence-Based Antibiotic Use Guidelines
Revised Schedule M: Discussion on Quality Risk Management
USFDA approval granted for blockbuster drug for Cancer treatment
Drug recall: B. Braun recalls Saline Solution due to this reason
USFDA issues warning letter to Eugia Pharma subsidiary of Aurobindo
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
