Biocon has received a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA) for its API facility located at Plot No 95, Visakha Pharmacity, SEZ, Jawaharlal Nehru Pharma City, Paravada, Andhra Pradesh. The inspection was conducted between 3rd and 7th November 2025. This acknowledgement reflects adherence to quality standards at Biocon’s manufacturing facility.
US FDA Approval
Biocon has been granted Voluntary Action Indicated (VAI) status from the United States Food and Drug Administration (US FDA). This status applies to Biocon’s API (Active Pharmaceutical Ingredient) manufacturing facility located in Andhra Pradesh.
Facility Details
The facility that received the VAI status is situated at Plot No 95, Visakha Pharmacity, Special Economic Zone (SEZ) in Jawaharlal Nehru Pharma City, Paravada, Andhra Pradesh. The FDA’s decision follows an inspection of the facility conducted between November 3rd and November 7th, 2025.
Inspection Details
The US FDA carried out an inspection at Biocon’s API facility between 3rd and 7th November 2025. Subsequent to this inspection, the VAI status has been conferred upon the facility. The company confirms its commitment to upholding the highest quality standards across all its manufacturing operations.
Source: BSE
