IPCA Labs shares fall as USFDA issues Form 483 to API unit with 11 observations

Shares of IPCA Laboratories (IPCA Labs) fell 3 per cent in Wednesday's trade after the US drug regulator issued a Form 483 with 11 (eleven) observations to its active pharmaceutical ingredient unit in Madhya Pradesh.

The US FDA had inspected the API facility at Ratlam of Madhya Pradesh for over a week. IPCA Labs said it intends to submit its comprehensive response on the observations to the US FDA soon, adding it would work closely with the agency to resolve these issues at the earliest.

Following the development, IPCA Labs shares fell 2.99 per cent to hit a low of Rs 712.85 on BSE. The stock is down 14 per cent year-to-date against a 6.37 per cent rise in the BSE Pharma index during the same period. Ahead of the USFDA action, IPCA Labs had an average price target of Rs 845, as per publicly available data with Trendlyne. The target suggested a 17 per cent potential upside on the counter.

In a filing to BSE, IPCA Labs said: "This is to inform you that the US FDA conducted the inspection of the Company’s APIs manufacturing facility situated at Ratlam, Madhya Pradesh from 5th June, 2023 to 13th June, 2023. At the conclusion of the inspection, the US FDA issued a Form 483 with 11 (eleven) observations."

IPCA said it takes the quality and compliance issues with utmost importance and remains committed to maintain the highest standards of quality and compliance across all its manufacturing facilities.

"The company will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest," it said.

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