HQ Team
October 27, 2022: Glenmark Pharmaceuticals, an Indian biopharmaceutical company, has received an “import alert” from USFDA for its Baddi facility in Himachal Pradesh.
The USFDA inspection happened on June 2022, according to a BSE filing.
“We now wish to inform you that the USFDA has placed the Baddi (India) facility under import alert 66-40. “The Baddi unit produces oral solids and liquid doses.
According to the USFDA, the 66-40 alert means “detention without physical examination of drugs from firms which have not met drug good manufacturing practices.
It also means foreign inspections of pharmaceutical manufacturers. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices.
Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or additional agreement.
The understanding or agreement must conclude that the FDA reveals conditions or practices warranting the detention of either particular products or all products manufactured by a firm.
Glenmark cannot sell any of its products from the facility to the US market, and the USFDA needs corrective actions from this facility.
The US revenues from products supplied by this facility contributed to 1-2% of the fiscal 2022 total revenues for the company.
“The company will engage with the agency to resolve the import alert at the earliest. The company is committed to maintaining the highest quality and compliant manufacturing standards at all of its facilities across the globe. “
Glenmark Pharmaceuticals focuses on therapeutic areas of respiratory, dermatology and oncology. The company has ten manufacturing facilities spread across four continents and operations in over 80 countries.
