Zydus gets EIR for formulations facility in Ahmedabad

PSM News /

Sep 21,2023

 

An EIR means closure of inspection. This means Zydus Lifesciences will soon get approvals for its filed Abbreviated New Drug Applications (ANDAs), enhancing its prospects to export existing and new products to the US market. The group now has 380 approvals and has so far filed at least 444 ANDAs since the commencement of the filing process in FY 2003-04 till June 30, this year.

 

Ahmedabad: Homegrown pharma major, Zydus Lifesciences Limited, announced that it has received Establishment Inspection Report.

 

An EIR means closure of inspection. This means Zydus Lifesciences will soon get approvals for its filed Abbreviated New Drug Applications (ANDAs), enhancing its prospects to export existing and new products to the US market. The group now has 380 approvals and has so far filed at least 444 ANDAs since the commencement of the filing process in FY 2003-04 till June 30, this year.

 

The pre-approval inspection (PAI) had concluded with NIL observations, according to the company’s stock exchange filing. The Ahmedabad-headquartered pharma major manufactures and markets a broad range of formulations as well as active pharmaceutical ingredients (API).

 

The company has research and development facilities in Gujarat, Sikkim, Goa, Maharashtra, and Himachal Pradesh in addition to manufacturing and R&D units in the US.

 

Source: Economic Times