Aarti Drugs gets 7 inspectional USFDA observations for Tarapur facility
Maharashtra: Aarti Drugs Limited has announced that the United States Food and Drug Administration (US FDA) has issued 7 inspectional observations in Form 483 for the API manufacturing facility of the Company at Plot No. E-22, MIDC, Tarapur, Maharashtra.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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.
