USFDA5 Nov 2026, 02:41 pm
Innoxel Lifesciences Receives USFDA EIR for Injectable Facility
AI Summary
Bharat Parenterals Limited announced that its subsidiary, Innoxel Lifesciences Private Limited, has received the Establishment Inspection Report (EIR) from the USFDA for its Vadodara facility. The inspection, conducted from April 13-20, 2026, focused on a general injectable product. The USFDA has closed the inspection, deeming the facility ready to support commercial operations. This follows an EU-GMP certification in March 2026 and the commencement of commercial supply to the US in October 2026. This EIR is a significant validation of Innoxel's quality systems, strengthening its position as a CDMO for regulated markets.
Key Highlights
- Subsidiary Innoxel Lifesciences received USFDA Establishment Inspection Report (EIR).
- Facility deemed ready to support commercial operations for injectable products.
- Inspection conducted April 13-20, 2026, for a general injectable product.
- EIR follows EU-GMP certification and recent US commercial launch.
- Strengthens company's position in regulated markets as a CDMO.
Price Impact
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