Hyderabad: Granules India Ltd on Monday said the US Food and Drug Administration (FDA) has completed inspections of two of its manufacturing sites in Vizag, Andhra Pradesh, and Jeedimetla, Telangana, and raised three observations for one of its Jeedimetla facility.
“There are no observations for Vizag facility and three observations (were raised) for Jeedimetla facility (by US FDA),” the company said.
The Hyderabad-based company didn’t specify the nature of the observations raised by the US drug regulator.
Granules said it will respond to the observations in 15 business days.
FDA form 483 or observations is handed over to the company’s management at the conclusion of an inspection, if an investigator observes any conditions that, in the investigator’s judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts of US.
After receiving observations, companies have to respond to the FDA in writing with their corrective action plan and then implement that corrective action plan expeditiously.
The observation doesn’t constitute the regulatory agency’s final action.
Both Vizag and Jeedimetla are active pharmaceutical ingredient (API) or bulk drugs manufacturing sites of Granules.
Jeedimetla facility located in Hyderabad manufactures APIs of anti-diabetic drug metformin, expectorant drug guaifenesin and anti-pain methocarbamol.
Granules, which is into the production of API, intermediates and finished dosages, is among the world’s leading API producers of paracetamol, metformin, guaifenesin and ibuprofen.
Shares of Granules rise 2.4% and were trading at ₹ 158 at 11.30am on BSE, while the benchmark Sensex gained 0.52% to 25,652.50 points.
