Pharma Giant Zydus Gets EIR for Formulations Facility in Ahmedabad

Months after inspection, the pharma company received the EIR from the USFDA which is a go-ahead nod that indicated the inspection is complete. Now, the company awaits another approval for its filed Abbreviated New Drug Applications (ANDAs), allowing the pharma company to export its existing and new products to the US market.

Ahmedabad's Zydus Lifesciences Limited has received an Establishment Inspection Report (EIR) approval from the US Food and Drug Administration (FDA) for its manufacturing facility near Ahmedabad.

Months back, in July this year, the United States Food and Drug Administration (USFDA) inspected Zydus Lifesciences' SEZ-II manufacturing facility in Ahmedabad.

The pharma company has now received the EIR from the USFDA which is a go-ahead nod that indicates the inspection is complete.

However, the company awaits another approval for its filed Abbreviated New Drug Applications (ANDAs), regulatory submission to the FDA for generic drugs, allowing the pharma company to export its existing and new products to the US market.

By far, the company has received 380 approvals and has filed at least 444 ANDAs since the commencement of the filing process in FY 2003-04 till June 30, this year.

For an Indian pharmaceutical that aims to export its products to the US market, getting an EIR approval is essential. Which requires filing for USFDA approval and submitting an ANDA application to the US Food and Drug Administration (FDA).

Following a rigorous procedure that involves filing review, substantive review, and facility inspection where the FDA inspects the facilities involved in manufacturing the drug and tests its samples, thereby getting the final approval when it satisfies certain standards and measures.

Although approval from the USFDA opens up opportunities for Indian pharmaceutical companies in the US market. However, it also means that these companies must adhere to stringent quality standards and regulations set by the USFDA. Failure to meet these may lead to serious consequences, including warning letters, import alerts, and even forced shutdowns

The United States generic drugs market is turning into a sweet spot for drug manufacturers in India as many Indian pharmaceuticals have successfully received the EIR this year. Apart from Zyrus, the names include Granules India Ltd, Lupin, Biocon, Strides Pharma Science and Dr Reddy's Laboratories.