The successful US FDA inspection helps the company as it plans to make a foray into highly regulated US generics market. Laurus said it has filed 3 Abbreviated New Drug Applications and in addition completed six product validations.
Laurus Labs on Friday said its Vizag unit has cleared the US FDA inspection without any Form 483 observations.
"The API facility of the Unit-2 has completed successful inspection without any 483 and the formulation unit in the same facility received EIR (establishment inspection report) on May 18," the company said in a statement.
The Unit-2 that manufactures active pharmaceutical ingredients and finished dosage formulations is located in APSEZ at Achutapuram, Vizag.
The plant approved by European regulator has a manufacturing capacity of 1 billion tablets per year. The active pharmaceutical ingredient (API) block has 12 reactors with total capacity of 84 KL.
The successful US FDA inspection helps the company as it plans to make a foray into highly regulated US generics market.
Laurus said it has filed 3 Abbreviated New Drug Applications (ANDA) and in addition completed six product validations. The company is working on a pipeline of 20 products for its US entry.
Laurus expects US generic business to contribute to its revenue from FY18 onwards.
The company, a major supplier of active pharmaceutical ingredients for anti-retroviral (used to suppress HIV infection) and hepatitis-C (used to fight liver infections) drugs for nine out of 10 world’s largest generic companies.
The company became publicly listed in December 2016.Shares of Laurus declined 2.34 percent to close at Rs.549.65 on BSE, while the benchmark Sensex gained 0.10 percent to end at 30,464.92 points.