AUROPHARMA Limited has announced that its subsidiary, Apitoria Pharma Private Limited, has received an Establishment Inspection Report (EIR) from the US FDA for its Apitoria Unit-II facility. The API manufacturing facility has been classified as “Voluntary Action Indicated” (VAI). This classification indicates that while the inspection has concluded, certain observations require attention. The company has been informed that the inspection is now closed under relevant FDA regulations.
US FDA Inspects AUROPHARMA Subsidiary Facility
AUROPHARMA Limited has disclosed the outcome of a recent inspection conducted by the United States Food and Drug Administration (US FDA) at its subsidiary’s facility. The inspection covered Apitoria Unit-II, an Active Pharmaceutical Ingredient (API) manufacturing plant operated by Apitoria Pharma Private Limited, a wholly owned subsidiary. The facility is located at Gaddapotharam, Industrial Development Area, Kazipally Industrial Area, Jinnaram Mandal, Sangareddy District, Telangana.
Inspection Details and Classification
The US FDA inspection took place from September 7th to September 15th, 2026. Following the inspection, Apitoria Pharma has received an Establishment Inspection Report (EIR). The classification assigned to the facility is “Voluntary Action Indicated” (VAI). This designation suggests that the inspection identified some observations that the company needs to address. The FDA has formally concluded that this inspection is now closed, in accordance with 21 CFR 20.64(d)(3).
AUROPHARMA has informed the stock exchanges about this development, as per the requirements of SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015. The company has requested that this information be taken on record.
Source: BSE
