Also known as: Fludara (brand)
Fludarabine is a purine analogue antimetabolite used in the treatment of B-cell chronic lymphocytic leukemia (CLL) and other hematological malignancies. It inhibits DNA synthesis by competing with adenosine and interfering with DNA polymerase and ribonucleotide reductase.
Mediocon Inc supplies Fludarabine IP/BP/USP as a certified active pharmaceutical ingredient for oncology pharmaceutical manufacturers. Manufactured under GMP-certified conditions with comprehensive quality controls and complete regulatory documentation for global compliance.
Key Features
Applications
Why Choose Mediocon
| Parameter | Specification |
|---|---|
| Assay | NLT 98.0% & NMT 102.0% |
| Loss on Drying | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| Residual Solvents | Complies ICH Q3C |
| Microbial Limits | Complies |
| Identification | HPLC / UV Compliant |
| pH (1% solution) | 3.0 – 4.5 |
| Packing | 25 kg HDPE drums / as per requirement |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Fludarabine (CAS 21679-14-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Fludarabine is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.
Export Markets
Quality & Compliance