USFDA30 Jul 2025, 01:19 pm
Bharat Parenterals' Subsidiary Innoxel Lifesciences Receives EIR from U.S. FDA
AI Summary
Bharat Parenterals Limited announced that its subsidiary, Innoxel Lifesciences Pvt. Ltd., has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its finished dosage manufacturing facility in Vadodara, Gujarat. The successful completion of the U.S. FDA inspection from April 28 to May 2, 2025 has led to the acceptance of the site for commercial operations for the product(s) under inspection. This achievement highlights Innoxel's commitment to global quality standards and its enhanced capability to supply high-quality pharmaceutical products to regulated markets, such as the United States and the European Union.
Key Highlights
- Bharat Parenterals Limited's subsidiary, Innoxel Lifesciences Pvt. Ltd., has received the Establishment Inspection Report (EIR) from the U.S. FDA.
- The U.S. FDA inspection conducted from April 28 to May 2, 2025 at Innoxel's manufacturing facility in Vadodara, Gujarat, has been successfully completed.
- Innoxel Lifesciences' finished dosage manufacturing facility in Vadodara, Gujarat, is now accepted for commercial operations for the product(s) under inspection.
- This milestone reinforces Innoxel's commitment to global quality benchmarks and enhances its capability to supply high-quality pharmaceutical products to regulated markets.
- Bharat Parenterals Limited is a leading pharmaceutical company engaged in the manufacturing and marketing of quality pharmaceutical formulations across domestic and international markets.