U.S. FDA Flags Two Lapses At Lupin’s Oral Solid Dosage Facility In Nagpur

The US FDA had inspected the Nagpur facility from July 3 to July 11.

The FDA issued a form 483 after the inspection. (Source: Unsplash)

The U.S. Food and Drug Administration flagged two procedural lapses related to laboratory controls at Lupin Ltd.’s oral solid dosage facility in Nagpur, Maharashtra.

Queries sent to Lupin via email have note received a response till now. The company is also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.

Shares of Lupin closed 1.43% higher on Thursday, compared to a 0.71% rise in the benchmark Sensex.

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Monal Sanghvi
Monal Sanghvi is a Senior Correspondent at NDTV Profit. She is a Chartered ... more
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