Granules India has received approval from the US Food and Drug Administration (FDA) for the  abbreviated new drug application (ANDA) for glycopyrrolate oral solution filed by its wholly owned foreign subsidiary Granules Pharmaceuticals Inc.

It is bioequivalent and therapeutically equivalent to the reference listed drug Cuvposa Oral Solution of Merz Pharmaceuticals LLC, the Hyderabad-based company said in a release on Tuesday. 

Glycopyrrolate oral solution is an anticholinergic medication indicated for paediatric patients aged 3-16 who have neurological conditions associated with drooling.

“As we strengthen Granules’ footprint in the US market, this approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards,” Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India, said.

Also read

Strides Pharma subsidiary receives FDA approval for Chennai facility 

Glenmark launches OTC eye drops to meet growing demand

The affordability question: New policy may speed up access but must address high costs and local testing concerns

Clinical trial waiver, a step to improve patient access, in need of guardrails

USFDA issues warning letter to Aurobindo arm Eugia Pharma

Related Topics