Aarti Drugs gets USFDA EIR for Tarapur facility
Mumbai: Aarti Drugs Limited has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) at the end of the inspection at API manufacturing facility of the Company at Plot No. E-22, MIDC, Tarapur, Maharashtra.
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).
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
"There are no financial or material impacts as on date. 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," the Company stated in a BSE filing.
Earlier, on September 25, the company received 7 inspectional observations in Form 483, where none of the observations were related to Data Integrity.
Read also: Aarti Drugs gets 7 inspectional USFDA observations for Tarapur facility
Aarti Drugs Ltd. was established in the year 1984 and forms part of $900 Million Aarti Group of Industries with R&D Division at Tarapur, Maharashtra Industrial Development Corporation (MIDC) in close vicinity to manufacturing locations.
The Company is engaged in the manufacturing of Active Pharmaceutical Ingredients (APIs), Pharma Intermediates, Specialty Chemicals and also produces Formulations with its wholly-owned subsidiary – Pinnacle Life Science Private Limited. Products under APIs includes Ciprofloxacin Hydrochloride, Metronidazole, Metformin HCL, Ketoconazole, Ofloxacin etc. whereas Specialty Chemicals includes Benzene Sulphonyl Chloride, Methyl Nicotinate etc.
Read also: USFDA inspection: Aurobindo Pharma arm Telangana facility gets 2 observations
