Lupin Strengthen Its Operations: Received EIR From US-FDA

Leading global pharmaceutical company Lupin Limited (Lupin) recently announced positive news regarding their Aurangabad manufacturing facility in India. The company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) following an inspection conducted from March 6th to March 15th, 2024.

The US FDA classification of “Voluntary Action Indicated” (VAI) for the Aurangabad facility signifies a successful outcome. This classification generally indicates that the US FDA did not observe any critical violations during the inspection. However, it’s important to note that the full details of the EIR are not publicly available.

Lupin expressed their satisfaction with the VAI classification. The company upholds quality and compliance as core values and is committed to meeting Current Good Manufacturing Practice (CGMP) standards across all its facilities. This positive outcome from the US FDA inspection strengthens Lupin’s position as a reliable supplier of high-quality pharmaceuticals to the US market. It also paves the way for continued collaboration with the US FDA to ensure ongoing compliance and patient safety.

“We are pleased to receive the EIR with VAI status from the US FDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide,” said Nilesh Gupta, Managing Director, Lupin.

A few days back, the global pharma company Lupin announced the launch of Mirabegron Extended-Release Tablets, 25 mg, in the United States after having received approval from the United States Food and Drug Administration. Mirabegron Extended-Release Tablets, 25 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 25 mg of Astellas Pharma Global Development, Inc. Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of USD 1,019 million in the US.

About Lupin Ltd

Lupin Limited is a transnational pharmaceutical company headquartered in Mumbai, India. The company is engaged in the development and commercialisation of a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets. The company has 15 manufacturing sites, 7 research centres, and more than 20,000 professionals working globally.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.