Bharat Parenterals announced that its subsidiary, Innoxel Lifesciences, 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.
This follows the successful completion of the U.S. FDA inspection conducted from April 28 to May 2, 2025. The facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms – Liquid Injectables and Oral Liquids.
With the receipt of the EIR, Innoxel Lifesciences has also received acceptance of the site 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, such as United States and the European Union.