New Delhi: Glenmark Pharmaceuticals on Tuesday said it has received four observations from the US health regulator for its Ankleshwar facility after inspection in December 2016.
The company’s Active Pharmaceutical Ingredients (API) plant at Ankleshwar was inspected by the United States Food and Drug Administration (USFDA) in December 2016, Glenmark Pharmaceuticals said in a filing to BSE.
“We received four observations from the FDA via the Form 483. We responded to the observations in January 2017," it added. At this point in time, the company has no outstanding items with the USFDA regarding this plant, it added.
As per FDA “An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts". It notifies the company’s management of objectionable conditions. Shares of Glenmark Pharmaceuticals today closed at Rs946.05 per scrip on BSE, up 0.29% from its previous close.