Lupin said there are no new drug master files (DMF) and abbreviated new drug applications (ANDA) applications pending review or approval from the Mandideep (Unit 1) facility
In a blow to India's third largest drug maker -- Lupin, the US Food & Drug Administration (USFDA) has classified inspection at the company's Mandideep Unit 1 in Madhya Pradesh as official action indicated (OAI), blocking product approvals from the site on concerns over manufacturing practices.
"USFDA stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed," the company said in an exchange filing.
The management said there are no new drug master files (DMF) and abbreviated new drug applications (ANDA) applications pending review or approval from the Mandideep (Unit 1) facility.
"The company does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility," the statement added.
The plant contributes less than 10 percent of US revenues and the OAI doesn't impact sales of products already approved and sold in the US market.
Lupin said it is in the process of sending further updates of its corrective actions to the USFDA and remains hopeful of a positive outcome.
USFDA made 22 observations to Lupin’s Mandideep plant after an inspection conducted in December 2018. The unit manufactures cephalosporin API and formulations.
This is Lupin’s third plant to face regulatory issues. The company is still in the process of resolving warning letters on Goa and Indore plants received in November 2017.According to USFDA data, of the 174 inspections in 2018 only four percent inspections have been classified as OAI, attracting agency’s regulatory and administrative action such as withholding new approvals, warning letters and import alerts in a worse case.