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US FDA places Glenmark Pharma's Baddi facility under import alert

US FDA places Glenmark Pharma's Baddi facility under import alert

Glenmark Pharmaceuticals has announced that the US FDA is placing the Baddi (India) facility under import alert 66-40. 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.

 

 

More news about: quality / gmp | Published by Sudeep Soparkar | January - 27 - 2023 | 492

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