Sun Pharma receives OAI status from USFDA for Dadra facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-04-12 06:12 GMT   |   Update On 2024-04-12 06:12 GMT

Mumbai: Sun Pharma has informed in a BSE filing that the US Food and Drug Administration (USFDA) has determined the inspection classification status of the Company's Dadra facility as Official Action Indicated (OAI).US FDA conducted an inspection at Company’s facility from December 4, 2023 to December 15, 2023. According to USFDA, OAI means regulatory and/or administrative actions...

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Mumbai: Sun Pharma has informed in a BSE filing that the US Food and Drug Administration (USFDA) has determined the inspection classification status of the Company's Dadra facility as Official Action Indicated (OAI).

US FDA conducted an inspection at Company’s facility from December 4, 2023 to December 15, 2023.

According to USFDA, OAI means regulatory and/or administrative actions are recommended.

"We will work with the regulator to achieve fully compliant status," the Company added.

Read also: Sun Pharma Advanced Research Company halts Parkinson's disease drug trial

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.

Read also: Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study FDC of Relugolix, Estradiol, Norethindrone Acetate

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