We are pleased to announce a significant regulatory achievement for one of our pivotal clinical programs, the Phase III endpoint bioequivalence (BE) study on Nitazoxanide drug which has been successfully inspected by the USFDA and approved for commercialization by the sponsor.
Study Overview
The Nitazoxanide drug BE study was designed to establish bioequivalence for a new formulation under rigorous regulatory scrutiny. Conducted across 15 clinical sites in India, the study enrolled 390 patients, ensuring a large sample size and data set for regulatory evaluation.
- Drug Name: Nitazoxanide drug
- Study Type: Phase III Endpoint Bioequivalence
- Total Patients Enrolled: 390
- Clinical Sites Involved: 15
- USFDA Inspection Conducted At: Goa and Kolhapur
- Outcome: Successful USFDA inspection and product approval granted to the sponsor in May 2025
Two of the participating sites, Goa and Kolhapur, were selected for official inspection by the United States Food & Drug Administration (USFDA). The inspections were conducted with stringent evaluation parameters and concluded without major observations, validating the quality systems, adherence to GCP (Good Clinical Practice), and overall operational integrity maintained throughout the study.
Approval Secured
As a direct result of the successful execution and data quality delivered, the sponsor has received final product approval from the USFDA, which is now listed in the FDA’s Orange Book under Application No. 218701.
You can view the official listing here: USFDA Database – Application No. 218701
This milestone is a testament to our continued focus on quality, compliance, and science-driven outcomes across all clinical phases.
What This Means
- Regulatory Confidence: The successful inspection reinforces the confidence of global regulators in the Indian clinical research ecosystem.
- Accelerated Access: The approval paves the way for faster patient access to Nitazoxanide drug, an important in treating parasitic and viral infections.
- Operational Excellence: Conducting a large-scale study across 15 sites with consistent protocol adherence and centralized data management showcases our execution capabilities.
- Global Readiness: Demonstrates our ability to manage end-to-end regulatory expectations and international sponsor collaborations.
Our Commitment to Quality
This achievement wouldn’t have been possible without the dedication and cross-functional collaboration of our clinical operations, quality assurance, regulatory affairs, site management, and biostatistics teams. We remain committed to upholding the highest standards of clinical research, ensuring patient safety, scientific accuracy, and regulatory compliance at every step.
We thank our sponsors, clinical partners, investigators, and most importantly, the patients who make research possible.
If you’re looking for a CRO partner that delivers global-standard studies with proven regulatory success, we’re ready to collaborate.
