Mumbai: Unichem Labs has announced that the United States Food and Drug Administration (USFDA) has issued three observations after the inspection at the Company’s Roha API facility.
The inspection was concucted from 16th June 2025 to 20th June 2025.
“The inspection closed with three observations which were more of procedural changes
with none of these related to data integrity.
The Company will provide the necessary response to USFDA within stipulated 15 days,” Unichem stated in a BSE filing.
with none of these related to data integrity.
The Company will provide the necessary response to USFDA within stipulated 15 days,” Unichem stated in a BSE filing.
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: Sandip Ghume to resign as Unichem Labs Deputy CFO, Key Managerial Personnel
