Laurus Labs gets no USFDA observations for Vizag unit

The maiden United States Food and Drug Administration (USFDA) audit for the unit was successfully completed without any observations and no Form 483 was issued, said Laurus Labs.

New Delhi: Drug firm Laurus Labs Friday said audit of its unit 4 at Visakhapatnam in Andhra Pradesh by the US health regulator has been completed without any observations.

Read Also: USFDA approves Glenmark Pharma anti-anginal drug Ranolazine ER Tablets

"The inspection of unit 4 was carried out from July 8 - 12, 2019," Laurus Labs said in a filing to BSE.

The maiden United States Food and Drug Administration (USFDA) audit for the unit was successfully completed without any observations and no Form 483 was issued, it added.

Read Also: Sun Pharma Research Arm- SPARC gets USFDA orphan drug designation for novel kinase inhibitor

As per the USFDA, Form 483 notifies the company's management of objectionable conditions.

Laurus Labs is one of the Indian manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. The company also manufactures APIs in Oncology and other therapeutic areas.

The company has also ventured into develop a Finished Dosages Forms on the back of existing strengths in 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.

Read Also: Solara Cuddalore facility successfully completes USFDA inspection