The United States Food and Drug Administration (USFDA) has closed its current inspection at Indian drugmaker Lupin's Mandideep Unit-1 facility. The inspection at this facility was initiated after issuing a form 483 with 16 observations.
The drug regulator issued eight observations each on a drug formulation facility and an API (active pharma ingredient) facility at the site.
Lupin's Mandideep Unit-1 was inspected between November 14-23, 2022. The company mentioned that it is committed to addressing the observations and will work with the USFDA to resolve the issues.
Pharma stocks have been in the news on Thursday with Glenmark's Goa unit getting a warning letter from the USFDA. Cipla's manufacturing unit in Goa also came under the classification of Official Action Indicated (OAI) status by the regulator.
CNBC-TV18 had reported exclusively on November 15 that the USFDA had begun inspecting the Mumbai-based Lupin's Mandideep manufacturing unit citing sources with knowledge of the matter. Mandideep Unit-1 had received a warning letter in 2019. Unit II at the Mandideep site of the company had also received an Establishment Inspection Report (EIR) from the regulator in April 2020.
The company, which received a USFDA warning letter on its active pharmaceutical ingredient (API) facility at Tarapur, and also certain negative observations on its biotech plant in Pune (both in Maharashtra) early November, did not offer a comment to CNBC-TV18's queries regarding the Mandideep plant inspection back then.
Shares of Lupin ended 0.15 percent lower at Rs 718.
First Published: Nov 24, 2022 5:00 PM IST
