Latest News | Lupin Gets EIR from USFDA for Pithampur Unit

New Delhi. Jul 11 (PTI) Drug firm Lupin on Tuesday said it has received Establishment Inspection Report (EIR) from the US health regulator for its Pithampur Unit-2 facility which manufactures oral solids and ophthalmic dosage forms.

The EIR was issued post the last inspection of the facility in Madhya Pradesh from March 21-29, 2023, the Mumbai-based company said in a statement.

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The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

“This is a significant milestone as we build back our reputation of being best-in-class in quality and compliance. We look forward to new product approvals and launches, especially ophthalmic products from this facility now,” Lupin Managing Director Nilesh Gupta stated.

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The US Food and Drug Administration issues an EIR on closure of an inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny.

As per the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)