This is further to the intimation given by Aarti Drugs Limited dated September 20, 2024, September 25, 2024 on inspection at API manufacturing facility of the Company at Plot No-E-22, MIDC, Tarapur, Maharashtra by United States Food and Drug Administration (US FDA) and intimation dated December 24, 2024 on receipt of EIR (Establishment Inspection Report) for the aforesaid facility. The Company is in receipt of the letter from the US FDA informing that Aarti Drugs Limited is no longer subject to refusal of admission and has been removed from Import Alert 66-40. Name of the Authority: United States Food and Drug Administration (US FDA).Nature and details of the action(s) taken, initiated or order(s) passed: United States Food and Drug Administration (US FDA) has reviewed the Form FDA 483 and establishment inspection report (EIR) and Company's response to the Form FDA 483 pertaining to the inspection conducted at API manufacturing facility of the Company located at Plot No.
E-22, MIDC, Tarapur, Maharashtra from September 12 to September 20, 2024. US FDA have determined from their review that Aarti Drugs Limited is no longer subject to refusal of admission and has been removed from Import Alert 66-40. Date of receipt of direction or order, including any ad-interim or interim orders, or any other communication from the authority February 14, 2025 Details of the violation(s) /contravention(s) committed or alleged to be committed: There is no violation(s) /contravention(s) committed or alleged to be committed Impact on financial, operation or other activities of the listed entity, quantifiable in monetary terms to the extent possible There are no financial or material impacts as on date.
US FDA has lifted the Import Alert 66-40. 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.
Aarti Drugs Limited is an India-based company, which is engaged in manufacturing of active pharmaceutical ingredients (APIs), pharma intermediates, specialty chemicals and formulations. The Company operates through pharmaceuticals segment. The Company's APIs products include iprofloxacin hydrochloride, metronidazole, metformin HCL, ketoconazole, ofloxacin, and others. Its specialty chemicals includes benzene sulphonyl chloride, methyl nicotinate, among others. Its pharma intermediates products include tinidazole, celecoxib, ciprofloxacin, clopidogrel, diclofenac, ketoconazole, raloxifene and zolpidem. Its products under development include alpha lipoic acid, itraconazole, ticagrelor, and sitagliptin. The Company's subsidiaries include Pinnacle Life Science Private Limited, Aarti Speciality Chemicals Limited, and Pinnacle Chile SPA.
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