With reference to its letter dated 26th October 2022 informing about the US FDA placing the Baddi (India) facility under import alert 66-40. Glenmark Pharmaceuticals has informed that due to medical necessity and potential drug shortage expectations, the US FDA has provided an exception which enables the Company to supply Atovaquone Oral Suspension USP 750mg/5 to the US market. The exception will be reconsidered if the market conditions change. 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.
The above information is a part of company’s filings submitted to BSE.
