Shares of Lupin Ltd soared 2% on 24 February after the company announced it had received an EIR report from the USFDA. 

In its regulatory filing, the company said that it received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) about its manufacturing facility in Somerset, New Jersey. The US regulator conducted an inspection between 27 January and 31 January 2025.

An Establishment Inspection Report (EIR) is issued by the US FDA following an inspection of a manufacturing facility to confirm compliance with current Good Manufacturing Practices (cGMP). In areas including production processes, quality control, and general safety criteria, the study evaluates the facility’s compliance with FDA laws.

The FDA requires an EIR to confirm that the facility meets regulatory standards before any pharmaceutical business may begin producing drugs for the US market. The report can be necessary to maintain production permission and market access for products marketed in the United States.

Lupin’s Managing Director, Nilesh Gupta, commented, “We are very pleased to have received the EIR for our Somerset facility. This milestone underscores our commitment to upholding the highest standards of quality and compliance, solidifying our position as a leading pharmaceutical manufacturer.”

Global pharmaceutical giant Lupin is well-established in more than 100 markets and specializes in complicated generics, branded and generic formulations, biotechnology products, and active pharmaceutical components.  While maintaining adherence to strict regulatory standards, the company continues to grow its capabilities in the industry by operating 15 manufacturing locations and seven research centres worldwide.

At 12:25 pm, the shares of Lupin were trading 0.91% higher at Rs 1,922.70 on NSE.

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