| Details | Specifications |
|---|---|
Therapeutic Category |
Antiviral, specifically a nucleoside reverse transcriptase inhibitor (NRTI) used to treat HIV infection |
CAT No. |
A400000 |
CAS No. |
188062-50-2 |
Mol. Weight |
670.75 g/mol. |
Dosage Form |
Oral tablets, Oral solution and Tablets for oral suspension |
Appearance |
White to almost white or off-white powder |
Synonyms |
Bis[[(1S,4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-enyl]methanol] sulfate;2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1S,4R)-, sulfate;Abacavir hemisulfate;Abacavir sulfate;2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1S,4R)-, sulfate |
Storage |
In a closed, light-resistant container at Control Room Temperature |
Disclaimer:
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Shilpa Pharma proudly offers high-quality Abacavir Sulfate, CAS 188062-50-2, a crucial active pharmaceutical ingredient (API) essential in the global fight against Human Immunodeficiency Virus (HIV) infection. As a synthetic carbocyclic nucleoside analog, Abacavir Sulfate belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs). Its chemical structure, specifically the carbocyclic guanosine analog, allows it to be phosphorylated intracellularly to its active triphosphate form, carbovir triphosphate. This active metabolite then competitively inhibits HIV-1 reverse transcriptase, an enzyme vital for the replication cycle of the virus, by incorporating itself into the nascent viral DNA chain. This incorporation results in premature chain termination, thereby impeding viral DNA synthesis and replication.
Our Abacavir Sulfate API is manufactured under stringent cGMP conditions, ensuring compliance with major pharmacopoeial standards including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). This adherence to global quality benchmarks makes our product suitable for pharmaceutical manufacturers worldwide seeking a reliable and compliant source. The strategic importance of Abacavir Sulfate cannot be overstated, as it forms a cornerstone of highly active antiretroviral therapy (HAART) regimens, often used in combination with other antiretroviral agents to achieve sustained viral suppression and improve patient outcomes. Shilpa Pharma, as one of the leading Abacavir Sulfate manufacturers in India, understands the critical demand for this API and is committed to ensuring its consistent availability.
The molecular architecture of Abacavir Sulfate is carefully designed to mimic natural deoxyguanosine, allowing it to act as a false substrate for HIV-1 reverse transcriptase. This mechanism is crucial for its therapeutic efficacy, targeting the viral replication machinery without significantly impacting host cellular DNA polymerases at therapeutic concentrations. The sulfate salt form enhances its bioavailability and formulation stability, making it a preferred choice for pharmaceutical development. Our commitment to purity and precise chemical synthesis ensures that the Abacavir Sulfate we supply meets the exact specifications required for effective drug product manufacturing.
Shilpa Pharma’s expertise in complex API synthesis positions us as a preferred partner for pharmaceutical companies globally. Our comprehensive range of pharmaceutical APIs includes critical compounds like Abacavir Sulfate, backed by robust quality systems and regulatory documentation. We recognize the evolving landscape of HIV treatment and the continuous need for high-quality, accessible APIs. Our manufacturing processes are designed for scalability and reproducibility, ensuring that our Abacavir Sulfate consistently meets the stringent quality and purity profiles demanded by regulatory authorities and ultimately, by patients.
Abacavir Sulfate is primarily utilized in the formulation of oral solid dosage forms, including tablets and capsules, for the treatment of HIV infection. Its inherent physicochemical properties, such as solubility and compressibility, are carefully considered during drug product development. Abacavir Sulfate exhibits good aqueous solubility, which is advantageous for achieving consistent bioavailability in oral preparations. However, careful selection of excipients is still paramount to ensure optimal dissolution profiles and stability across varying storage conditions. Common excipients compatible with Abacavir Sulfate include microcrystalline cellulose, lactose, croscarmellose sodium, and magnesium stearate, selected for their binding, disintegrant, and lubricating properties.
Formulation scientists must account for the API’s potential for polymorphism and its impact on manufacturing processes and final product performance. Shilpa Pharma provides comprehensive technical data and support to assist clients in selecting the appropriate crystalline form and optimizing their formulation strategies. Our expertise extends to supporting clients through formulation development, process scale-up, and technology transfer, ensuring a smooth transition from laboratory to commercial production. As a dedicated Abacavir Sulfate supplier from India, we understand the nuances of API behavior in various matrices and offer insights to overcome potential challenges.
Special formulation considerations for Abacavir Sulfate include ensuring content uniformity, particularly in combination products where it is co-formulated with other antiretroviral agents such as Lamivudine or Dolutegravir. The API’s flow properties and compaction characteristics are critical for efficient tableting operations, requiring precise control over particle size distribution and morphology. Our analytical capabilities include particle size analysis, ensuring that the physical attributes of our Abacavir Sulfate are optimized for downstream processing by our clients.
Shilpa Pharma’s CDMO services are specifically tailored to support pharmaceutical manufacturers at every stage of their drug development lifecycle. From custom synthesis of specialized intermediates to contract manufacturing of the final API, we provide integrated solutions. Our team of experienced chemists and engineers collaborates closely with clients to address specific formulation challenges, offering expertise in solid-state characterization, pre-formulation studies, and process optimization to achieve desired product specifications and regulatory compliance. This collaborative approach minimizes development risks and accelerates time-to-market for essential medicines.
The safe handling and storage of Abacavir Sulfate in industrial settings are paramount to maintaining product quality and ensuring personnel safety. Shilpa Pharma recommends storing Abacavir Sulfate in its original, tightly sealed containers at controlled room temperature, typically between 20°C to 25°C, with excursions permitted to 15°C to 30°C, protected from light and excessive humidity. The API should be stored in a dry, well-ventilated area. Our standard packaging includes double-polyethylene bags sealed inside HDPE drums, designed to preserve the API’s purity and stability throughout its specified shelf life and retest period, which is typically 24-36 months when stored under recommended conditions.
Personnel handling Abacavir Sulfate should adhere to strict occupational health and safety guidelines. This includes wearing appropriate Personal Protective Equipment (PPE) such as chemical-resistant gloves, safety glasses or face shields, and laboratory coats. Adequate local exhaust ventilation or process enclosures are essential to minimize exposure to airborne particles during weighing, dispensing, and processing. A comprehensive Safety Data Sheet (SDS) is provided with every shipment, detailing hazard identification, first-aid measures, fire-fighting procedures, and accidental release measures, ensuring that our clients are fully equipped to handle the material safely.
Shilpa Pharma ensures that every batch of Abacavir Sulfate exporter India receives is accompanied by a complete suite of quality documentation. This includes a detailed Certificate of Analysis (CoA) confirming compliance with pharmacopoeial specifications (USP, BP, EP, IP), a Certificate of Conformance, and a comprehensive SDS. We also provide impurity profiling, including identification and quantification of specified and unspecified impurities, and residual solvent analysis, all performed using validated analytical methods in our state-of-the-art QC laboratories. Our adherence to ICH Q3D guidelines for elemental impurities ensures that our API meets global safety standards, reflecting our commitment to patient safety.
Furthermore, our manufacturing processes for Abacavir Sulfate are designed to comply with international regulatory frameworks, including REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulations where applicable for specific export markets. Shilpa Pharma maintains a robust quality management system, certified to ISO standards and compliant with current Good Manufacturing Practices (cGMP), providing an auditable supply chain and complete traceability for all materials. This meticulous approach to quality and safety underscores our reputation as a trusted supplier of critical pharmaceutical APIs.
The pricing of pharmaceutical APIs like Abacavir Sulfate is influenced by a complex interplay of factors, including the purity specification required, batch size, and the extensive regulatory documentation demanded by global health authorities. The cost of raw materials, which can fluctuate based on global supply and demand dynamics, currency exchange rates, and the complexity of the synthetic route, all contribute significantly to the final API price. Buyers often seek suppliers who can offer competitive pricing without compromising on the stringent quality and regulatory standards essential for pharmaceutical products.
Indian GMP manufacturers, such as Shilpa Pharma, are uniquely positioned to offer highly competitive pricing for Abacavir Sulfate manufacturers in India due to several strategic advantages. These include optimized manufacturing efficiencies, access to a skilled scientific workforce, and well-established supply chains for key intermediates. Our ability to scale production from research quantities to full commercial volumes, coupled with flexible Minimum Order Quantities (MOQs), allows us to accommodate diverse client needs, from small-scale R&D projects to large-volume commercial supply.
Sourcing Abacavir Sulfate from a vertically integrated manufacturer like Shilpa Pharma offers distinct advantages over engaging with trading intermediaries. Vertical integration provides greater control over the entire production process, from key starting materials to the final API, ensuring consistent quality, supply chain transparency, and often, more favorable pricing due to reduced overheads and multiple mark-ups. This direct relationship fosters better communication, allowing for quicker resolution of technical or logistical queries and a more reliable supply.
For long-term supply stability and cost predictability, Shilpa Pharma encourages establishing long-term supply agreements. These agreements provide significant benefits to pharmaceutical manufacturers by locking in pricing, ensuring dedicated production capacity, and safeguarding against supply disruptions. Such partnerships are crucial for strategic planning and maintaining consistent drug product availability in the market. To receive a tailored quotation or discuss supply requirements, buyers are encouraged to contact us directly.
Pharmaceutical manufacturers, generic drug companies, CDMOs, and research organizations across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa consistently choose Shilpa Pharma as their preferred supplier for Abacavir Sulfate due to our unwavering commitment to quality, regulatory excellence, and customer-centric services. Our manufacturing facilities in India are not only ISO-certified but also operate under strict GMP compliance, ensuring that every batch of Abacavir Sulfate meets the highest international standards for purity, potency, and safety. This foundational commitment to quality is what distinguishes us as leading Abacavir Sulfate manufacturers in India.
We provide comprehensive regulatory dossier support, including US-DMF (Drug Master File), CEP/EDMF (Certificate of Suitability to the monographs of the European Pharmacopoeia), and Certificate of Pharmaceutical Product (COPP), facilitating faster drug product approvals for our global clientele. Our state-of-the-art analytical laboratories are equipped with advanced instrumentation, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Karl Fischer titrators for moisture content, and particle size analyzers, ensuring meticulous quality control and detailed impurity profiling for all our APIs.
Shilpa Pharma offers an extensive range of integrated services beyond API supply. Our CDMO services encompass custom synthesis of complex intermediates, contract manufacturing, and process development from initial lab-scale research to full commercial production. We provide dedicated technical support for formulation queries, assisting clients in optimizing their drug product development processes and troubleshooting any API-related challenges. Our vast experience in worldwide export means we understand the logistical and regulatory nuances of shipping pharmaceutical raw materials across continents, ensuring timely and compliant delivery.
Choosing Shilpa Pharma means partnering with a company that prioritizes an auditable supply chain, complete transparency, and a straightforward procurement process from initial inquiry to final delivery. Our reputation for reliability, coupled with our deep expertise in pharmaceutical chemistry and regulatory affairs, makes us an ideal partner for securing a consistent and high-quality supply of Abacavir Sulfate. To learn more about our capabilities and commitment to excellence, please visit our about Shilpa Pharma page.
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