Glenmark gets one USFDA observation for Aurangabad facility

Written by Ruchika Sharma Published On 2022-07-02T16:29:45+05:30 | Updated On 2 July 2022 4:29 PM IST

Glenmark gets one USFDA observation for Aurangabad facility

New Delhi: Glenmark Pharmaceuticals Limited has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with one observation after an inspection at the Company's formulation manufacturing facility based out of Aurangabad, India.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The inspection was held between June 27, 2022 and July 1, 2022.

"The company is committed to undertake all necessary steps required to address their observation at the earliest. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," the company said in a BSE filing.

Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

glenmarkglenmark newsUSFDAUSFDA inspectionAurangabad facility

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