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Granules Pharma’s ANDA for Glycopyrrolate Oral Solution Accepted by USFDA

Granules Pharma’s ANDA for Glycopyrrolate Oral Solution 1mg/5mL accepted by USFDA.

Mrudula Kulkarni
By Mrudula Kulkarni
Managing Editor - Pharma Now
Aug 21, 2024Updated Jun 26, 2025 · 2 min read
Granules Pharma’s ANDA for Glycopyrrolate Oral Solution Accepted by USFDA
https://granulesindia.com/about-us/
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Reviewed by Mrudula Kulkarni, Managing Editor - Pharma Now

Granules India said that its fully owned overseas subsidiary, Granules Pharmaceuticals, filed an Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL, which was accepted by the US Food and Drug Administration (FDA).It is therapeutically and bioequivalent to Merz Pharmaceuticals' Cuvposa Oral Solution, 1 mg/5 mL, the reference medication.
Paediatric patients with neurological problems linked to excessive drooling between the ages of three and sixteen are recommended to use Glycopyrrolate Oral Solution, an anticholinergic drug.

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Mrudula Kulkarni
Written by
Mrudula Kulkarni
Managing Editor - Pharma Now

My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.



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