Express Pharma

Aurobindo Pharma gets warning letter from US FDA for API facility

The action follows the recent inspection of the facility by the US Food and Drug Administration (FDA) in August 2021, the drugmaker said in a regulatory filing

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Aurobindo Pharma yesterday said it has received a warning letter from the US health regulator for its Hyderabad-based Unit I, an Active Pharmaceutical Ingredient (API) manufacturing facility.

The action follows the recent inspection of the facility by the US Food and Drug Administration (FDA) in August 2021, the drugmaker said in a regulatory filing. “The company believes that this will not impact the existing business from this facility,” it noted.

The drugmaker stated that it will be engaging with the regulator and is fully committed to resolve the issue at the earliest. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, it noted.

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