CAS No: 136470-78-5) Nucleoside Reverse Transcriptase Inhibitor
Nucleoside Reverse Transcriptase Inhibitor (NRTI) for HIV-1 Antiretroviral Therapy
Abacavir (CAS 136470-78-5) 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 Abacavir API require stringent genotoxic impurity control, particularly for carbovir-related process impurities. Abacavir'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 Abacavir 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.
Key Features
HPLC purity ≥98.0% with full pharmacopeial identification (IR, HPLC, mass spec)
Strict genotoxic impurity profiling per ICH M7 guidelines
Available as base, hydrochloride, and sulfate salt forms
WHO-GMP facility with validated manufacturing process for HAART applications
Applications
Combination antiretroviral therapy (HAART) for HIV-1 in adults and paediatrics
Fixed-dose combination (FDC) tablets with lamivudine and dolutegravir
Oral solution formulation for paediatric HIV treatment programs
Generic ARV manufacturing for WHO prequalification programs
Why Choose Swapnroop for Abacavir?
WHO-GMP certified Aurangabad facility with audited manufacturing documentation
DMF filing support for USFDA, EMA, and CDSCO regulated markets
Fresh monthly batch supply with validated 36-month stability data
Dedicated account management for ARV procurement programs
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