Granules India confirms US FDA audit at Gagillapur facility: Report

Granules India | CMP: Rs XX | The share price declined sharply amid reports of a surprise inspection currently underway at a key facility of the company. The inspection has been underway at Granules' facility at Gagilapur in Hyderabad since Monday, reported CNBC TV18 citing sources.

Granules India has confirmed CNBC-TV18's report regarding an ongoing US FDA investigation at its Gagillapur facility in Hyderabad. The company stated that the audit is currently in progress and will update the exchange upon its completion.

A surprise inspection was reported at Granules India's facility in Gagilapur, Hyderabad, according to CNBC-TV18. The inspection, which began on Monday, is focused on the facility responsible for the company's Pharmaceutical Formulations Intermediates (PFI) and formulation businesses. This facility contributes over 70 percent of Granules India's revenue for the June quarter.

Out of the 16 Abbreviated New Drug Applications (ANDAs) pending for the US markets, 11 are associated with this facility. To date, 36 ANDAs from this location have been approved.

Granules India's management has been contacted for comment by CNBC-TV18, but a response has yet to be received. Moneycontrol could not independently verify the details of the inspection. The news of the inspection has led to a sharp decline in Granules India Ltd.'s share price.

For the June quarter, Granules India reported a 19.7 percent increase in revenue, totaling Rs 1,179.8 crore. The company's margin expanded by 800 basis points year-over-year, reaching 22 percent from the previous 14 percent.