- 15 Dec 2021
- ICICIdirect Research
Establishment Inspection Report from USFDA for Goa facilityLUPIN - 659 Change: 18.75 (2.93 %)
News: Lupin has received the Establishment Inspection Report (EIR) from USFDA for its Goa manufacturing facility, post the inspection of this facility in September 2021 (received 7 form 483 observations). USFDA has changed the inspection classification of the facility to Voluntary Action Indicated (VAI).
Views: EIR for the Goa facility (with voluntary action initiated or VAI status) could provide a significant respite in Lupin’s intense drive to address pending compliance issues (four facilities with warning letter or OAI). The US contributed 38% of total revenues in FY21 and to add to Lupin’s woes, for the last four years the USFDA compliance track record has been inconsistent. Going forward, issues such as progress on the margins front, pricing pressure and competition in key US products besides pending resolution at other key plants still continue to weigh.