Laurus Labs gets 2 USFDA observations for its API facilities in Visakhapatnam

"This is a regular surveillance audit by USFDA, and no data integrity issues were observed in the inspection," Laurus Labs added.

New Delhi: Drugmaker Laurus Labs Limited, recently said that the US health regulator has made two observations after inspection of its API facilities in Units 1 and 3 at Parawada, Visakhapatnam, Andhra Pradesh.

The company has completed the United States Food and Drug Administration (USFDA) inspection of its active pharmaceutical ingredient (API) facilities in Units 1 and 3 at Parawada, Visakhapatnam, Andhra Pradesh, with two observations, Laurus Labs said in a filing to the BSE.

The observations are procedural in nature, it added.

"This is a regular surveillance audit by USFDA, and no data integrity issues were observed in the inspection," it further added.

The company, however, did not share any details about the observations made by the regulator.

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The company is a manufacturer of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. The company also manufactures APIs in Oncology and other therapeutic areas.

APIs with a current capacity of 5 billion units per year, expandable up to 8 billion units per year. The company is also driving growth opportunities in the Synthesis and Ingredients businesses.

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