- 30 Sep 2022
- ICICIdirect Research
LUPIN GETS WARNING LETTER FOR TARAPUR FACILITY
LUPIN - 2082 Change: 12.10 (0.58 %)News:
Lupin has received a warning letter from USFDA for the Tarapur facility post its inspection from March 22, 2022 to April 4, 2022. Lupin indicated that the warning letter will not have an impact on disruption of supplies or existing revenues from operations of this facility.
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The Tarapur facility was placed under USFDA OAI status from January, 2020 after it received three observations during USFDA inspection in September, 2019. Tarapur is a fermentation and chemical synthesis based multi-product API manufacturing facility but the company is currently procuring newer APIs from Nagpur and Vizag facility while older ones are from the Tarapur and Dabhasa facility. We believe the warning letter post Lupin's remediation measures reflect poorly and extended USFDA compliance issues would continue to affect Lupin's utilisation of assets for the US.
Impact:
Negative.