Granules India share price fell 4 percent intraday on September 9 after the company received six observations from the US Food and Drug Administration (USFDA).
At 09:41 am, Granules India was quoting at Rs 660.95, down Rs 26.90, or 3.91 percent, on the BSE.
USFDA concluded its inspection at the company's Gagillapur facility in Hyderabad, Telangana, conducted between August 26 to September 6, 2024.
The inspection covered both Current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) processes, the company said.
The company to address the observations promptly and will submit its response to the USFDA within the stipulated timeframe, it added.
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Earlier in August, Granules Pharmaceuticals, Inc., a wholly-owned subsidiary of Granules India, received USFDA approval for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL.
This product is bioequivalent and therapeutically equivalent to Merz Pharmaceuticals’ Cuvposa Oral Solution 1 mg/5 mL.
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