Glenmark Pharma North Carolina facility gets USFDA OAI status

Published On 2022-08-25 06:25 GMT | Update On 2022-08-25 06:25 GMT

Mumbai: Glenmark Pharmaceuticals Limited has recently announced that the company has received Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA) for the company's Monroe, North Carolina (USA) facility.

The OAI classification implies inter‐alia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.

Monroe facility was inspected from April 04 to May 19, 2022, and received Form‐483 with 17 observations.

The Company had done a voluntary recall of all its products from this site in August 2021 and since then has not been commercializing any product from this site.

Glenmark continues to cooperate with the USFDA and is committed to undertake all necessary steps required to address their observations at the earliest," the company stated in a BSE filing.

"The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe," Glenmark further added.

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.

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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

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Glenmark Pharma North Carolina facility gets USFDA OAI status

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