Aurobindo Pharma has announced that APL Healthcare's Unit-IV manufacturing facility has received Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration following a comprehensive inspection of the facility. The company has now received the official Establishment Inspection Report (EIR) confirming the VAI classification, and the inspection is officially closed.

FDA Inspection Details

The US FDA conducted a detailed inspection of APL Healthcare's Unit-IV facility over a ten-day period from December 8 to December 17, 2025. During this regulatory review, the inspection team identified and documented five specific issues at the manufacturing site. The facility is located at Palchur village and part of Palepalem Village Naidupeta Mandal, SPSR Nellore District, Andhra Pradesh.

VAI Classification Significance

The VAI classification indicates that while the FDA identified certain observations during the inspection, these issues do not warrant immediate regulatory action that would halt manufacturing operations. This classification allows the facility to continue its operations while the company addresses the noted concerns. The facility received a Form 483 with the five observations at the end of the inspection.

Official Confirmation and Current Status

Aurobindo Pharma has officially notified the stock exchanges about receiving the Establishment Inspection Report (EIR) classifying the facility as VAI. The inspection is now officially closed, representing a significant milestone for the facility's ongoing compliance with US FDA standards and regulations. APL Healthcare Limited is a wholly owned subsidiary of Aurobindo Pharma Limited.

Regulatory Compliance

The company has fulfilled its disclosure obligations under Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, by informing both the National Stock Exchange of India Limited and BSE Limited about the FDA classification outcome.

Aurobindo Pharma 's wholly owned subsidiary Eugia Pharma Specialities Limited has announced the commercial launch of pomalidomide capsules in the United States market. The company has launched the product in multiple strengths of 1 mg, 2 mg, 3 mg and 4 mg, marking a significant entry into the oncology segment.

Product Launch Details

The newly launched pomalidomide capsules serve as a generic equivalent of Pomalyst® Capsules of BMS Pharmaceuticals Corp. Eugia Pharma Specialities Limited was one of the First-to-File (FTF) ANDA applicants for this product, providing a competitive advantage in the market entry. The product will be manufactured at Eugia Unit-I facility.

Market Opportunity and Therapeutic Use

According to IQVIA MAT data for the twelve months ending January 2026, pomalidomide capsules have an estimated market size of approximately US$ 3.3 billion in the United States. This substantial market opportunity underscores the commercial potential for generic manufacturers entering this therapeutic space.

Pomalidomide is a third-generation immunomodulatory drug (IMiD) used in combination with dexamethasone and sometimes bortezomib to treat relapsed or refractory multiple myeloma and AIDS-related Kaposi sarcoma. The availability of generic versions enhances treatment accessibility and provides cost-effective options for patients requiring this critical oncology medication.

Strategic Significance

This product launch strengthens Aurobindo Pharma's presence in the US pharmaceutical market through its subsidiary Eugia Pharma Specialities Limited. The First-to-File status provides competitive positioning in this high-value oncology segment. The introduction of pomalidomide capsules adds to the company's oncology portfolio, demonstrating continued commitment to developing and commercializing complex generic formulations in major global markets.