Lupin's Goa unit comes under USFDA scanner

MUMBAI: The list of woes of Indian drug companies with quality compliance continues. This time it is India's fifth-largest drug maker Lupin, which has come under US regulatory probe for deviations from good manufacturing practices, some of which may include serious deviations like cross contamination between separate production blocks.

"Lupin's Goa manufacturing site underwent an extensive inspection, by the FDA (Food and Drug Administration of the US) last week. The regulator is believed to have found manufacturing-related deficiencies on at least nine counts," said a source who is directly in the know of this development, but cannot be named due to the sensitivity of the issue. Lupin did not respond to an email sent by ET seeking comment.

According to the source, FDA's observations included issues related to mismatch in production logs, out-of-specification products and a couple others that may require a longer remediation plan.

Lupin's Goa unit mostly handles non-antibiotic oral drugs and is used for supplies to the US market.