Aarti Drugs Tarapur Facility Gets US FDA Clearance

26 Dec 2024 , 11:48 PM

Aarti Drugs received an Establishment Inspection Report from the United States Food and Drug Administration. EIR is in respect of API manufacturing facility at Tarapur, Maharashtra.

The same inspection conducted earlier this year has been classified as ‘voluntary action indicated'(VAI), which ascertains that the said facility is in compliance with CGMP. No violation or contravention was observed in inspection, and there is no financial or operational impact for the company due to closing the inspection.

On December 26, 2024, shares of Aarti Drugs closed at ₹452,80 which is a 4.85% dip than the previous close. Aarti Drugs shares has witnessed a 8% dip in the last one year, and 10% dip in the last six months.

The plant will be cleared to ship vital APIs such as Ciprofloxacin HCl, Zolpidem Tartrate, Raloxifene HCl, Celecoxib, and Niacin for US. Aarti Drugs had communicated to the stakeholders prior to inspection. The firm had issued the updates of 20 September and 25 September 2024.

The clearance of inspection as per guidelines of 21 CFR 20.64(d)(3) and thus restates its commitment towards upholding high manufacturing standards of the company.