USFDA flags Sun Pharmas Halol facility

The United States Food and Drug Administration (USFDA) concluded its Good Manufacturing Practices (GMP) inspection at Sun Pharmaceutical Industries’ facility, located in Halol, Gujarat, with eight observations.

The inspection was held from December 3 to 13, 2019. As the agency issued a Form 483 with eight observations, the company stated in a press release that it has been preparing for the response, which will be submitted to the USFDA in a time period of 15 business working days. To enhance its GMP compliance, the company strives to address these observations with great importance.

Sun Pharmaceutical Industries Limited manufactures and sells pharmaceutical formulations and Active Pharmaceutical Ingredients (APIs) mainly in India and the United States. The company offers formulations for various therapeutic areas including cardiology, psychiatry, neurology, gastroenterology, and diabetology.

On Monday, the stock of the company opened at Rs 430.30, down by 1.90 per cent or Rs 8.35 per share. The 52-week high is Rs 484.10 and 52-week low is Rs 350.40 on BSE.