Glenmark Pharmaceuticals Limited has announced that the company has received Official Action Indicated (OAI) status from the US Food and Drug Administration (USFDA) for the Monroe, North Carolina (USA) facility.
The OAI classification implies the inter-alia that the US FDA might withhold the approval of any pending product applications, and the supplements filed from the facility till the outstanding observations are resolved. The Monroe facility was inspected from April 4, 2022 to May 19, 2022, and has received form-483 with the 17 observations.
Glenmark Pharmaceuticals had done a voluntary of all its products from this site in August 2021, and since then has not been commercializing any product from the North Carolina site. The company continues to cooperate with the US FDA and is also committed to undertake all the necessary steps required to address their observations at the earliest.
The company added that it is committed to maintain the highest quality, and complaint manufacturing standards at all of its facilities across the globe. Glenmark Pharmaceuticals Limited is a global pharmaceutical company with presence across specialty, generics, and OTC businesses and with the operations in more than 50 countries. The key therapy of Glenmark Pharmaceutical’s focus areas globally are dermatology, oncology, and respiratory.