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USFDA classifies Glenmark's Monroe plant as Official Action Indicated (OAI)

The business said in a statement to stock markets late Tuesday night that "the OAI designation means, among other things, that the USFDA may suspend clearance of any ongoing product applications or supplements filed from this facility until the outstanding observations are resolved."

August 25, 2022 8:22 IST | India Infoline News Service

The USFDA has designated the pharmaceutical manufacturer Glenmark's Monroe, North Carolina plant as Official Action Indicated (OAI), which could potentially prevent the facility from submitting new applications for approval.

The business said in a statement to stock markets late Tuesday night that "the OAI designation means, among other things, that the USFDA may suspend clearance of any ongoing product applications or supplements filed from this facility until the outstanding observations are resolved."

"Glenmark is dedicated to taking all necessary actions to resolve the US FDA's observations as soon as possible and is committed to continuing its cooperation with them. The business is dedicated to upholding the highest production standards of compliance and quality at all of its locations across the world "the sentence included.

In August 2021, Glenmark voluntarily recalled all of its items from this site, and since then, it has not commercialized any products from this site, according to Glenmark.

Although the Monroe plant's contribution to the P&L is now insignificant, Glenmark had anticipated that the location will play a significant role in the introduction of distinctive products into the American market. In its annual report, Glenmark stated that it intended to submit at least five product registrations from the location.


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