Laurus Labs Hyderabad facility successfully completes USFDA audit

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-09-16 06:00 GMT   |   Update On 2024-09-16 06:00 GMT

Hyderabad: Laurus Labs Ltd., a research and development driven pharmaceutical and biotech company in India has announced the successful completion of the US Food and Drug Administration (US FDA) audit of its API manufacturing facility at Hyderabad.

The audit concluded with zero Form 483 observations.
The US FDA inspection, conducted from 9th to 13th September, focused on evaluating the facility's adherence to global regulatory requirements and best practices.
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Laurus Labs' API manufacturing facility, located at DS-1, IKP Knowledge Park, Genome Valley, Shameerpet, Telangana is instrumental in developing Active Pharmaceutical Ingredients.

Laurus Labs is an Indian pharmaceutical company headquartered in Hyderabad. The Company's major focus areas include anti-retroviral, Hepatitis C, and Oncology drugs.

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Most of the Laurus Labs manufacturing facilities are approved by major regulatory authorities USFDA, WHO-Geneva, UK-MHRA, etc. 

Read also: USFDA inspection: Laurus Labs arm gets 5 observations for AP facility


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