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Lupin's US FDA compliance woes suggest the problem runs deeper
Tuesday, January 14, 2020, 7:45 PM
There is no end in sight for India's third largest drug maker Lupin's regulatory woes. The company on January 13 said its Tarapur active pharmaceutical ingredient(API) manufacturing site in Maharashtra has been classified as official action indicated (OAI) by US FDA. The site was inspected by US FDA between September 16 and 20 last year, and issued three observations at the end of inspection.
Regulatory Compliance
USFDA
Warning Letter
Lupin
Goa Plant
OAI
Api
Somerset
Tarapur Site
Indore Unit2
Mandideep Unit1
Remediation
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