USFDA issues warning letter to Sun Pharma Halol facility

Written by Ruchika Sharma Published On 2022-12-17T12:30:03+05:30 | Updated On 17 Dec 2022 12:55 PM IST

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The Warning Letter issued by USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

New Delhi: Drug major Sun Pharma has announced that the company has received a warning letter from the US Food and Drug Administration (USFDA) for its Halol facility which is already under an import alert. The warning letter summarises violations with respect to Current Good Manufacturing Practice (cGMP) regulations, the Mumbai-based company said in a regulatory filing.

The US Food and Drug Administration shall make public the contents of the Warning Letter in due course, it added.

On December 8, Sun Pharma had announced that its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market.

The Warning Letter issued by USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.

The US FDA then checks to ensure that the company's corrections are adequate.

Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.

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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751