Boon For Lupin As FDA Upgrades Somerset Site Status

Stricken US Facility Handed Voluntary Action Indicated Status By FDA

Looking to provide evidence of its extended measures to improve quality, compliance and oversight, Lupin has received positive news from the FDA for its US-based manufacturing facility in Somerset, New Jersey.

manufacturing facility
Lupin must return its facilities to FDA compliance • Source: Shutterstock

Lupin is celebrating a “significant milestone for our Somerset site, and an important step in our journey to build back our reputation as best in class in quality and compliance,” following a catalogue of reprimands for its US-based and US-exporting facilities.

The Indian firm has received the establishment inspection report for its US-based manufacturing facility in Somerset, New Jersey, from the...

Generics Bulletin Podcast

Stay ahead of every shift in generics and biosimilars.

Generics Bulletin brings you the latest updates that matter for the off-patent industry.

More from Manufacturing

More from Business