Shares of Granules India Ltd crashed 4% on 9 September after the company announced receiving six observations from the US Food and Drug Administration (USFDA). 

The US regulator conducted an inspection at the company’s Gagillapur facility in Hyderabad, Telangana, between 26 August and 6 September. The inspection covered both Pre-Approval Inspection (PAI) and Current Good Manufacturing Practices (cGMP). 

After conducting the inspection, the USFDA issued a Form 483 with six observations. 

The company said that they will address these observations promptly and will submit their responses to the US health regulator within the stipulated timeline. 

Earlier in August, the company’s wholly-owned subsidiary, Granules Pharmaceuticals Inc. received approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL.

The Glycopyrrolate Oral Solution 1mg/5mL is a bioequivalent and therapeutically equivalent to Merz Pharmaceuticals’ Cuvposa Oral Solutions 1 mg/5 ml. 

At 3:30 pm, the shares of Granules India closed 2.22% lower at Rs 672.85 on NSE.

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