Aurobindo Pharma’s Hyderabad unit receives warning letter from USFDA

Hyderabad: Aurobindo Pharma has received a warning letter from the US Health Regulator for its Hyderabad based Unit I, which is an Active Pharmaceutical Ingredient (API) manufacturing facility.

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The warning letter was issued following a recent inspection of the facility by the US Food and Drug Administration (USFDA) during August last year.

Aurobindo Pharma in a regulatory filing informed that this will not impact the existing business from this facility. The company further said that it will engage with the regulator and is fully committed to resolving the issue at the earliest.  

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The Company said that it is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.

A warning letter is issued when the US health regulator finds that the manufacturer has violated its regulations significantly which includes poor manufacturing practices, problems with claims for what a product can do or incorrect directions for use besides others.

The letter also makes clear that the company must correct the problem and provides directions and a timeframe of its plans for corrections. Following this FDA checks to ensure that the company’s corrections are adequate.

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