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Bharat Parenterals’ arm receives EIR from USFDA for Vadodara facility
Nov-05-2026

Bharat Parenterals’ subsidiary -- Innoxel Lifesciences has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for the unannounced PAI (Pre-Approval Inspection) of the Injectable Product at its finished dosage manufacturing facility in Vadodara, Gujarat. The inspection, conducted from April 13 to April 20, 2026, included product-specific coverage of a general injectable product. The USFDA has completed its assessment of the EIR and Innoxel's written responses, closed the inspection, and confirmed that it considers the facility ready to support commercial operations of the subject product, with no further questions.

This is the second EIR received by the Vadodara facility, following the EIR issued in July 2025. The site also received an EU-GMP certificate covering all four of its manufacturing lines in March 2026, following an inspection by Belgium's Federal Agency for Medicines and Health Products (FAMHP) with zero critical and zero major observations. In October 2026, Innoxel commenced commercial supply to the United States with the launch of its first contract manufacturing (CMO) product by its sponsor partner.

Bharat Parenterals is engaged in to the business of the Pharmaceuticals & Drugs.

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