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Bharat Parenterals arm Innoxel gets 5 observations after USFDA inspection

21-Apr-26   15:30 Hrs IST
The inspection of the General Injectables Block was carried out from 13 April to 17 April 2026 and concluded on 20 April 2026.

At the conclusion of the inspection, the USFDA issued five observations under a Voluntary Action Indicated (VAI) classification. The company said its subsidiary will respond within the prescribed timeline, while the final Establishment Inspection Report (EIR) is awaited.

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

Commenting on the development, the company's management said, 'A surprise USFDA inspection of a sterile injectables block, concluding with a few procedural observations under a VAI classification, reflects the consistency of quality and compliance systems at Innoxel. The company continues to focus on strengthening its manufacturing and regulatory capabilities.'

Bharat Parenterals as a pharmaceutical company. The Company develops anti-retroviral drugs in the form of tablets, capsules, oral liquids, eye drops, lotion, creams, and injections for the treatment of various diseases. Bharat Parenterals serves clients in India.

The company reported consolidated net loss of Rs 4.39 crore in Q3 FY26 as against net loss of Rs 1.67 crore in the same quarter last year. Revenue from operations fell 9.8% YoY to Rs 65.19 crore in the quarter ended 31 December 2026.

The counter added 1.31% to Rs 1,201.25 on the BSE.

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