Aarti Drugs Limited announced that it has successfully been removed from the United States Food and Drug Administration (US FDA) Import Alert 66-40, paving the way for the company to resume exports to the US market. The pharmaceutical firm confirmed receiving an official letter from the US FDA on February 14, 2025, stating that it is no longer subject to refusal of admission into the US.
The development follows a series of inspections at Aarti Drugs’ API manufacturing facility located at Plot No. E-22, MIDC, Tarapur, Maharashtra. The facility underwent scrutiny between September 12 and September 20, 2024, after which the company received a Form FDA 483 citing observations. Following a detailed response from the company and further evaluation by the US FDA, the regulatory body determined that the company had addressed the concerns satisfactorily.
As per Aarti Drugs, there have been no violations or contraventions committed. The removal from the import alert means the company can now export key pharmaceutical products, including Ciprofloxacin HCl API, Zolpidem Tartrate API, Raloxifene HCl API, Celecoxib API, and Niacin API, to the US market without restrictions. The company stated that there are no financial or material impacts from this development as of now.
This clearance provides a significant boost for Aarti Drugs as it re-establishes its presence in the US market. The company remains committed to maintaining compliance with global regulatory standards to ensure uninterrupted business operations.
