Lupin gets EIR on FDA inspection related to NDMA in Valsartan

Pharma major Lupin said the US Food & Drug Administration has given it an Establishment Inspection Report for its Tarapur facility.

The company had two months ago pointed out that the inspection, carried out in August, had been completed with one observation related to what it called a “procedural deficiency”.

The receipt of an EIR is usually considered good news.

The inspection was carried out in the context of worldwide alarm about the possibility of certain pharmaceutical ingredients containing carcinogenic impurities.

The inspectors focused on the safety of Lupin’s Valsartan, Losartan and Irbesartan active pharmaceutical ingredients in light of the safety alert issued by Regulatory Authorities on the NDMA (classified as a probable human carcinogen) impurity in Valsartan API supplied by some companies.

During the inspection, the US FDA concluded that the manufacturing processes of Lupin ‘Sartans’ are safe with no chance of presence of the NDMA impurity in the APIs.

Founded in 1992, the Tarapur facility is a state-of-the-art unit for manufacturing Active Pharmaceuticals Ingredients (API), both fermentation-based and synthetic.

Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “For Lupin, meeting and exceeding global quality and procedural standards has always been paramount. We are committed to upholding the highest levels of quality and compliance standards across all our facilities .”

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