Lupin: Enhanced Efforts Needed To Resolve Regulatory Issues, Says Motilal Oswal
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Motilal Oswal Report
The 13 observations in Form 483 issued by the U.S. Food and Drug Administration post the inspection over September-November 2020 largely pertain to cleanliness and equipment maintenance, out-of-specification samples, the stability program, and the lack of training given to employees.
The Somerset facility currently contributes less than 5% to Lupin Ltd.’s revenues globally.
Ongoing sales from Somerset (currently under official action indicated) are not impacted, but future approvals are likely to get delayed.
We remain positive on Lupin owing to -
- a ramp-up in recent niche launches and
- its outperformance in Domestic Formulations.
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