Unichem Labs Roha facility gets 3 USFDA observations

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-06-23T12:19:35+05:30 | Updated On 23 Jun 2025 12:19 PM IST

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.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent 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

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751