Lupin's Pithampur Unit-3 Secures US FDA EIR Approval

Lupin Limited, a global pharmaceutical company, has received the Establishment Inspection Report (EIR) of the Lupin Pithampur Unit-3 plant in Madhya Pradesh.

This report is a follow-up to a successful inspection conducted between July 7 and July 17, 2025, and is a milestone regulatory requirement to the company.

Pithampur Unit-3 plant plays a central role in the global supply chain of Lupin since it produces metered dose inhalers, dry powder inhalers, topical formulations and nasal solutions to several different markets.

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Commenting on the development, Nilesh Gupta, Managing Director of Lupin, said, “We are pleased to have received the EIR from the US FDA for our Pithampur Unit-3 facility. This demonstrates our commitment to maintaining the highest standards of compliance and quality, as we aim to deliver high-quality, affordable medicines from world-class factories for patients worldwide.”

The EIR confirms that the facility has been able to achieve the necessary quality and compliance standards required by the FDA, which would make Lupin a reputable global supplier. Headquartered in Mumbai, India, Lupin Limited is one of the most reputable pharmaceutical firms in the world and its products are sold in over 100 markets.

The portfolio of the company consists of branded and generic formulae, complex generics, biotechnology products and active pharmaceutical ingredients (APIs). The US FDA EIR enhances US FDA Lupin; concentration on regulatory excellence combined with its operational integrity that are two important pillars behind the Lupin expansion program in a competitive international pharmaceuticals environment.