Laurus Labs bags USFDA zero observations
DSIJ Intelligence / 20 May 2017
The recently listed pharma major Laurus Labs’ API facility of its Vizag unit received the USFDA approval without any Form 483 observations, and its formulation unit received the EIR (establishment inspection report) on May 18, 2017.
The recently listed pharma major Laurus Labs’ API facility of its Vizag unit received the USFDA approval without any Form 483 observations, and its formulation unit received the EIR (establishment inspection report) on May 18, 2017.
The unit, also approved by European regulator, manufactures active pharmaceutical ingredients along with finished dosage formulations and has a manufacturing capacity of 1 billion tablets on an annual basis in APSEZ at Achutapuram, Vizag.
The company, which is soon entering the US generics market, had filed three Abbreviated New Drug Applications (ANDA) and also completed six product validations. Laurus Labs has 20 products in pipeline for its launch in the US markets.
The company is also a major supplier of active pharmaceutical ingredients for anti-retroviral drugs, used for suppressing HIV infection, and hepatitis-C drugs which is used for the treatment of liver infections, for most of the world’s largest generic companies.