USFDA Inspection at Innoxel Lifesciences Private Limited

Bharat Parenterals Limited (BSE: 541096) hereby informs that its subsidiary, Innoxel Lifesciences Private Limited, was subject to a surprise / unannounced inspection by the United States Food and Drug Administration (U.S. FDA) at its finished dosage manufacturing facility in Vadodara, Gujarat.

The inspection of the General Injectables Block was conducted from April 13, 2026 to April 17, 2026 and April 20, 2026.

At the conclusion of the inspection, the U.S. FDA has issued five (5) observations under a Voluntary Action Indicated (VAI) classification. The Company's subsidiary will submit its response within the prescribed timelines. The final Establishment Inspection Report (EIR) is awaited.

The General Injectables Block is a key manufacturing facility supporting the supply of sterile injectable formulations to regulated markets, including the United States and the European Union.

For reference, the regulatory track record of the facility is as follows:

- U.S. FDA inspection (April-May 2025): EIR received on July 30, 2025

- EU GMP inspection by Belgium's Federal Agency for Medicines and Health Products (FAMHP) (November 24-28, 2025): Zero critical and zero major observations. EUGMP Certificate for all 4 lines issued on March 06, 2026.

- U.S. FDA inspection (April 13-17, 20, 2026): Five observations issued under VAI classification

Commenting on the development, the management stated: A surprise U.S. FDA inspection of a sterile injectables block, concluding with few procedural observations under a VAI classification, reflects the consistency of the quality and compliance systems at Innoxel. The Company continues to focus on strengthening its manufacturing and regulatory capabilities.

Bharat Parenterals Limited is a BSE-listed pharmaceutical manufacturer with over three decades of formulation expertise, exporting to 40+ countries. Through its subsidiaries, Innoxel Lifesciences Private Limited (complex dosage forms, U.S. FDA and EU-focused) and Varenyam Healthcare (domestic branded generics), the Group operates an integrated platform across sterile injectables, oral solids, and specialty formulations.

Shares of Bharat Parenterals Ltd was last trading in BSE at Rs. 1213.00 as compared to the previous close of Rs. 1185.70. The total number of shares traded during the day was 2520 in over 31 trades.

The stock hit an intraday high of Rs. 1248.00 and intraday low of 1185.30. The net turnover during the day was Rs. 3039205.00.

Source : Equity Bulls

Keywords

BharatParenterals INE365Y01019 Pharmaceuticals InnoxelLifesciences USFDA Inspection