Aarti Drugs receives EIR from USFDA for Tarapur API facility
Drug Approval

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP

  • By IPP Bureau | December 26, 2024

United States Food and Drug Administration (USFDA) had conducted an inspection at API manufacturing facility of Aarti Drugs at Plot No. E-22, MIDC, Tarapur, Maharashtra. Now, Aarti Drugs is in receipt of the Establishment Inspection Report (EIR). EIR is a report which includes details of audit done.

FDA has determined that the inspection classification of this facility is "voluntary action indicated" (VAI). Based on this inspection, this facility is considered to be in a minimally acceptable state of compliance with regard to current good manufacturing practice (CGMP).

There are no financial or material impacts as on date. The company is in receipt of the Establishment Inspection Report (EIR) from US FDA concluding the inspection as closed under 21 CFR 20.64(d)(3). Due to this Company can export the products such as Ciprofloxacin HCl API, Zolpidem Tartrate API, Raloxifene HCl API, Celecoxib API and Niacin API in US Market.

Upcoming E-conference

Other Related stories

Startup

Digitization