Aarti Drugs shares jump 11% after USFDA’s clearance for its Tarapur facility

Shares of Aarti Drugs shot up to 11% on Tuesday after it announced that the company received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its active pharmaceutical ingredient (API) manufacturing facility located in Tarapur, Maharashtra.

As at 15:26 IST on Tuesday, December 24, 2024, the drugmaker’s share price were trading over 12% higher at ₹474.65.

The inspection, conducted earlier this year, has been concluded as “closed,” with the inspection classification designated as “voluntary action indicated” (VAI).

“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),” the company said in a statement.

No violations or contraventions were identified during the inspection, and no financial or material impact has been reported.

The EIR indicates that Aarti Drugs’ facility is now cleared to continue exporting products such as Ciprofloxacin HCl, Zolpidem Tartrate, Raloxifene HCl, Celecoxib, and Niacin APIs to the U.S. market.

Aarti Drugs had previously intimated the market on the inspection carried out by the US FDA, with updates shared on September 20 and 25, 2024. The company assured stakeholders that the inspection’s closure would not affect its operations or financial standing.

The full Establishment Inspection Report has been filed under the 21 CFR 20.64(d)(3) guideline.