Unichem Labs Pithampur API facility gets 4 USFDA observations
Mumbai: Unichem Labs has announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with four observations at the Company’s Pithampur API facility.
The inspection was held from 24th February 2025 to 28th February 2025.
The inspection closed with four observations which were more of procedural changes with none of these related to data integrity.
"The Company will provide the necessary response on these observations to USFDA within stipulated 15 days," Unichem informed in a BSE filing.
Read also: Unichem Labs Goa facility gets VAI status from USFDA
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.
