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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
Por Mrudula Kulkarni
Editor Gerente - Pharma Now
21 ago 2024Updated Jun 26, 2025 · 2 min de lectura
Granules Pharma’s ANDA for Glycopyrrolate Oral Solution Accepted by USFDA
https://granulesindia.com/about-us/
Reportaje con ayuda de IA
Reviewed by Mrudula Kulkarni, Editor Gerente - 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.

Mrudula Kulkarni
Written by
Mrudula Kulkarni
Editor Gerente - 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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