Unichem Labs gets 5 USFDA observations for Goa facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-07-16 07:00 GMT   |   Update On 2024-07-16 07:00 GMT
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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.
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"The observations do not impact business continuity and the Company’s supplies to the US market," Unichem further stated.

Read also: Sandip Ghume to resign as Unichem Labs Deputy CFO, Key Managerial Personnel

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.

Read also: Unichem Labs bags USFDA nod for hypertension drug Doxazosin

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