Key Event Details
Innoxel Lifesciences Private Limited, a subsidiary of Bharat Parenterals Limited, received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) via letter dated November 4, 2026. The report pertains to an unannounced Pre-Approval Inspection (PAI) of injectable products at Innoxel's finished dosage manufacturing facility located in Vadodara, Gujarat.
Inspection Timeline and Scope
The inspection was conducted from April 13, 2026 to April 20, 2026. The inspection included product-specific coverage of a general injectable product.
Regulatory Outcome
The USFDA completed its assessment of the EIR and Innoxel's written responses, closed the inspection, and considers the facility ready to support commercial operations of the subject product with no further questions.
Facility History
This is the second EIR received by the Vadodara facility, following an EIR issued in July 2025. The site also received an EU-GMP certificate covering all four manufacturing lines in March 2026 from Belgium's Federal Agency for Medicines and Health Products (FAMHP), with zero critical and zero major observations.
Commercial Operations
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.
Management Commentary
Mr. Bhahim Desai, Director – Strategy & Investor Relations, stated that the closure of the unannounced USFDA inspection validates the quality systems at Innoxel and strengthens the company's position as it scales complex injectables portfolio and partnerships for US and European markets.
Company Background
Bharat Parenterals Limited is a Gujarat-based pharmaceutical company exporting to over 40 countries. Innoxel Lifesciences is a contract development and manufacturing organization (CDMO) focused on complex and specialty generic injectables for regulated markets.