Innoxel Lifesciences successfully completes USFDA inspection of its Vadodara unit
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hindu
3 days ago
- The Hindu
Zydus gets U.S. FDA nod for Diltiazem Hydrochloride tablets
Generic drugmaker Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for Diltiazem Hydrochloride tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg. A generic of Cardizem Tablets, the drug is indicated for management of chronic stable angina and angina due to coronary artery spasm. Diltiazem Hydrochloride tablets had annual sales of $13.9 million in the U.S., Zydus said, citing IQVIA MAT June 2025 numbers. The approved drug will be produced at its plant in Baddi, Himachal Pradesh, the company said. Belonging to a class of drugs called calcium-channel blockers, Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle, it said. Zydus Lifesciences shares closed 2.18% higher at ₹955.90 apiece on the BSE.
Business Standard
3 days ago
- Business Standard
Dr Reddy's Lab receives EIR from USFDA for Telangana API facility
Dr. Reddy's Laboratories announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API manufacturing facility (CTO-5) located in Miryalaguda, Telangana. The USFDA has classified the inspection outcome as "Voluntary Action Indicated" (VAI) and confirmed that the inspection is officially closed. According to an exchange filing dated 24 May 2025, the inspection was conducted between 19 May and 24 May 2025. At the conclusion of the inspection, the USFDA had issued a Form 483 with two observations, which Dr. Reddys stated it would address within the stipulated timeline. Hyderabad-based Dr. Reddys Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. The companys consolidated net profit rose 1.8% to Rs 1,418.10 crore on 11.4% increase in revenue from operations to Rs 8,545.20 crore in Q1 FY26 over Q1 FY25. The scrip rose 0.61% to Rs 1,219 on the BSE.
Business Standard
30-07-2025
- Business Standard
Innoxel Lifesciences successfully completes USFDA inspection of its Vadodara unit
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.
