Indoco Remedies' Goa plant classified as OAI by US FDA

Indoco Remedies said that the U.S. Food and Drug Administration, post an inspection conducted in the July 2024, has classified the company's Goa-based facility as 'official action indicated' (OAI).

In a regulatory filing made after market hours on Friday, the pharmaceutical company informed that it has received the regulatory status from American drug regulatory for its facilities located at Goa Plant-II & III. This action from the US FDA follows the inspection conducted by USFDA in July 2024.

The USFDA has determined that the inspection classification of this facility remains as Official Action Indicated (OAI).

The facility had been inspected by the USFDA in February 2023 and had received an OAI status in May 2023.

 

"Indoco is comprehensively working on the remedial action plan at the Facility which will be completed by Q3 2024, the company said in a statement.

Indoco had planned to inform USFDA for the inspection readiness post completion of the remedial action. However, USFDA had visited the Facility in July 2024, while the remedial action was still in progress. Hence, the compliance status of the Facility received as OAI dated 10th October 2024, remains the same.

Aditi Panandikar, managing director, said, We are working holistically towards meeting the expectations of the regulators and are committed to remain focussed on compliance to deliver products of high-quality standards."

Indoco is a fully integrated, research-oriented pharmaceutical company. The company has 11 manufacturing facilities, 7 for FDFs and 4 for APIs, supported by an R&D Centre and a CRO facility.

The company's consolidated revenue grew by 1.8% YoY to Rs 424.29 crore while the profit after tax declined by 89.3% YoY to Rs 2.62 crore in Q1 FY25 over Q1 FY24.

The scrip shed 0.50% to currently trade at Rs 334.95 on the BSE.

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