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 |