Glenmark gets OAI classification from USFDA for Monroe site

Drug maker Glenmark said the USFDA has classified its formulations manufacturing site in Monroe, North Carolina as Official Action Indicated (OAI) which may potentially block new approvals filed from the 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," the company said in a statement to stock exchanges in the late evening Tuesday.

"Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps

required to address their observations at the earliest. The Company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe," the statement added.

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

Glenmak said it 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.

Currently Monroe plant contribution is negligible to the P&L, but Glenmark has expected the site to be one of the key contributors to launching differentiated products in the U.S. market. Glenmark said in its annual report that it was planning at least five product filings from the site.