The shares of Lupin Ltd fell 2.7 percent on Thursday after the company's Tarapur Plant received a warning letter from the US Food and Drug Administration (US FDA). The US FDA inspected the company's Tarapur plant from March 22 to April 4.
The shares of the pharmaceutical company were trading 1.4 percent down at Rs 661 on BSE at 10:51 am.
The company does not believe that the warning letter will have an impact on supplies and the existing revenue from facility. The company has said it will work with the US FDA to resolve issues.
The Tarapur facility had received an OAI Status in January 2020.
Earlier the company's plant in Goa had received a warning letter which was later lifted in December 2021. The company's Somerset Facility in New Jersey had received an Establishment Inspection Report from the USFDA in July 2022. The EIR indicates Voluntary Action Indicated Status and 13 observations were issued in March 2022. Five of these observations were repeat observations by USFDA. The facility was issued a warning letter by USFDA in June 2021.
The company had hired former food and drug administration officer Diana Amador-Toro as the Senior Vice President of Global Compliance.
Apart from the Official Action Indicated (OAI) status on Tarapur plant, the Pithampur Unit 2 of the company had also received a warning letter in November 2017 and six observations in January 2019, after reinspection. The Mandideep Unit 1 formulation was also issued a warning letter in September 2019.
First Published: Sept 29, 2022 11:28 AM IST