USFDA conducts pre-approval inspection at Indoco Remedies' Goa facility; Stock slips 4%

Indoco Remedies has informed to the exchanges that a pre-approval inspection (“PAI”) was conducted by the United States Food and Drug Administration (“USFDA”) at the at the Company’s Goa facility.

According to the exchange filing, the inspection was conducted at Solid Oral Formulation facility (Plant I) located at Goa from October 12, 2023 to October 18, 2023.

Further, the pre-approval inspection was conducted for two drug product applications (ANDAs) filed from this facility. 

The USFDA has issued ‘four observations’ in Form 483 at the end of the pre-approval inspection, the company said on Thursday.

At around 10:17 AM, shares of Indoco Remedies plunged around 4% at Rs 337.25 per share on the BSE.