Lupin gets EIR from US FDA for its Ankleshwar Manufacturing Facility

The company develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

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The drug will be available in one strength with a fixed dose to be taken once daily. (File)

Lupin Limited on Saturday announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Ankleshwar manufacturing facility, located in Gujarat, India. The facility was inspected from August 16-19, 2022.

“We are very happy to have received the EIR for our Ankleshwar facility from US FDA. We remain committed to enhancing compliance and quality standards across all our manufacturing sites,” Nilesh Gupta, Managing Director, Lupin said in a statement on Saturday.

Lupin, a transnational pharmaceutical company, is headquartered in Mumbai, Maharashtra. The company develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

According to the company, Lupin has a leading position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas.

ALSO READ | USFDA approves Lupin’s extended release tablets for overactive bladder

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This article was first uploaded on October three, twenty twenty-two, at ten minutes past nine in the morning.
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