WHO Essential Medicine NRTI for HIV-1 Antiretroviral Combination Therapy
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Udenafil (CAS 268203-93-6) is a carbocyclic nucleoside analogue that inhibits HIV-1 reverse transcriptase by competing with the natural substrate deoxyguanosine-5'-triphosphate and incorporating into viral DNA, causing chain termination. It is a cornerstone component of highly active antiretroviral therapy (HAART) and is listed on the WHO Essential Medicines List for HIV treatment in adults and children.
Pharmaceutical companies sourcing Udenafil API require stringent genotoxic impurity control, particularly for carbovir-related process impurities. Udenafil's unique carbocyclic structure demands HPLC purity ≥98% with specific rotation testing and low residual solvent content per ICH Q3C guidelines. Buyers evaluate batch-to-batch consistency in polymorphic form and particle size distribution for tablet compression performance.
Swapnroop Drugs and Pharmaceuticals supplies Udenafil API from our WHO-GMP certified Aurangabad facility with complete IP/BP/USP pharmacopeial compliance. We support ANDA/NDA filing through DMF-referenced documentation, provide fresh monthly batches with 36-month shelf life, and export to 25+ countries with full regulatory dossier support.
Udenafil API is supplied in triple-layer HDPE drums (5 kg, 10 kg, 25 kg) with oxygen absorbers and moisture barrier inner bags to protect the carbocyclic structure during transit. Cold chain logistics (2–8°C) available for export consignments to regulated markets.
Get Bulk QuoteThe CAS number for Udenafil (base form) is 268203-93-6. It is a carbocyclic nucleoside analogue available as base, hydrochloride, and sulfate salt forms from Swapnroop.
Udenafil is a Nucleoside Reverse Transcriptase Inhibitor (NRTI) used as a key component of HAART regimens for HIV-1 treatment in adults and children, listed on the WHO Essential Medicines List.
Udenafil API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, strict genotoxic impurity profiling per ICH M7, and full pharmacopeial identification testing.
Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply available for larger volumes.
Yes, Swapnroop provides full DMF-grade documentation for Udenafil API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Udenafil API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Udenafil API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Udenafil API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Udenafil API pricing, samples, and sourcing support.