Laurus Labs gets 3 USFDA observations for Visakhapatnam facility

The inspection of Visakhapatnam facility in Andhra Pradesh was completed with three observations, 'which are procedural in nature'. No data integrity issues were observed in the inspection, Laurus Labs said.

New Delhi: Drug firm Laurus Labs on Thursday said US health regulator has made three observations after completing the inspection of its Visakhapatnam facility in Andhra Pradesh.

The company has completed the pre approval inspection (PAI) for an active pharmaceutical ingredient (API) manufactured at its Units 1&3, located at Visakhapatnam by the United States Food and Drug Administration, Laurus Labs said in a filing to the BSE.

The inspection was completed with three observations, 'which are procedural in nature'. No data integrity issues were observed in the inspection, it added.

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The company, however, did not provide any details about the observations.

The inspection was carried out from November 18 - 21, 2019, it added.

Laurus Labs is a research & development driven and fully integrated pharmaceutical company in India. The Company is a manufacturer of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus also manufactures APIs in Oncology and other therapeutic areas.

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