Laurus Labs has successfully completed the US Food and Drug Administration (US FDA) audit of its API manufacturing facility at Hyderabad. The audit concluded with zero Form 483 observations, reaffirming Laurus Labs commitment to maintaining the highest standards of quality, safety, and compliance.
The USFDA inspection, conducted from September 9, 2024 to September 13, 2024 focused on evaluating the facility's adherence to global regulatory requirements and best practices. Laurus Labs' API manufacturing facility, located at DS-1, IKP Knowledge Park, Genome Valley, Shameerpet, Telangana is instrumental in developing Active Pharmaceutical Ingredients, bolstering the company’s ability to deliver high-quality, innovative pharmaceutical solutions to its global customers.
Laurus Labs is a leading research and development driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of APIs for anti-retroviral (ARV) and Hepatitis C. It also manufactures APIs in oncology and other therapeutic areas.
| Company Name | CMP |
|---|---|
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| Dr. Reddys Lab | 1215.55 |
| Cipla | 1228.55 |
| Zydus Lifesciences | 926.50 |
| Lupin | 2307.25 |
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