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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.

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  • Aug 21, 2024

  • Mrudula Kulkarni

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

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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