Sun Pharma Halol facility gets OAI from USFDA

Written by Ruchika Sharma Published On 2022-08-18T16:00:37+05:30 | Updated On 18 Aug 2022 4:00 PM IST

New Delhi: Sun Pharmaceutical Industries Limited has announced that the Company has received a communication from the USFDA indicating the inspection classification of Halol at Gujarat facility as "Official Action Indicated" (OAI).

The OAI classification implies inter-alia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.

"The Company continues to manufacture and distribute existing products for the US market, thereby not likely to have any material adverse impact on current business from the Halol facility. Sun Pharma continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the Company's remedial action," the company stated.

"Sun Pharma remains committed to being GMP compliant and in supplying high-quality products to its customers and patients globally," the company added.

Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufacture and market 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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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