Unichem Labs gets 5 USFDA observations for Goa facility

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-07-16 07:00 GMT | Update On 2024-07-16 07:00 GMT

Mumbai: Unichem Labs has received five observations from the United States Food and Drug Administration (USFDA) at the closure of the inspection at the Company's Goa formulation facility.

USFDA conducted an inspection from 8th July 2024 to 15th July 2024.

"The inspection closed with five observations which were more of procedural changes with none of these related to data integrity. The Company will provide the necessary response with in stipulated 15 working days," the Company stated in a BSE filing.

"The observations do not impact business continuity and the Company’s supplies to the US market," Unichem further stated.

Headquartered in Mumbai, Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. The company was founded in 1944 by Padmabhushan Late Mr. Amrut V Mody. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor 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

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Unichem Labs gets 5 USFDA observations for Goa facility

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