Roxadustat API

Roxadustat API: Premium Quality Bulk Supply by Ayurvite Wellness Pvt. Ltd.

In the rapidly evolving pharmaceutical landscape, the quality and reliability of Active Pharmaceutical Ingredients (APIs) are paramount to the efficacy and safety of medicinal products. Ayurvite Wellness Pvt. Ltd. stands as a leader in the API export sector, offering high-quality Roxadustat API to pharmaceutical companies worldwide. Our commitment to superior quality, stringent regulatory compliance, and customer-centric services makes us the preferred partner for bulk API procurement. This comprehensive product page delves into every aspect of Roxadustat API, highlighting its chemical properties, mechanism of action, therapeutic uses, manufacturing excellence, and the unparalleled advantages of partnering with Ayurvite Wellness.

What is Roxadustat API?

Roxadustat, also known by its chemical name FG-4592, is an orally active small molecule that functions as a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is primarily used in the treatment of anemia associated with chronic kidney disease (CKD), including patients undergoing dialysis and those not yet requiring dialysis. As an API, Roxadustat serves as the active ingredient in various pharmaceutical formulations, ensuring the therapeutic efficacy of anti-anemic medications.

Chemical Composition

Roxadustat is a well-defined chemical compound with specific properties that contribute to its pharmacological effects.

• IUPAC Name: (2S)-2-[4-(3,4-Dihydroxyphenyl)-3,5-dimethylpyrazol-1-yl]-N,N-dimethylacetamide
• Molecular Formula: C₁₅H₁₈N₄O₃
• Molecular Weight: 290.34 g/mol
• CAS Number: 1442491-99-3

Chemical Specifications

• Appearance: White to off-white crystalline powder
• Purity: ≥ 99.0%
• Solubility: Soluble in DMSO, methanol, and ethanol; sparingly soluble in water
• Melting Point: 200-205°C
• pH: 7.0-7.5 (1% solution)

Mechanism of Action

Roxadustat Dihydrochloride functions primarily as an inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PH). By inhibiting HIF-PH, Roxadustat stabilizes hypoxia-inducible factors (HIFs), particularly HIF-2α, leading to the upregulation of erythropoietin (EPO) and other genes involved in iron metabolism and erythropoiesis. This mechanism effectively stimulates red blood cell production, alleviating anemia in patients with chronic kidney disease.

• HIF Stabilization: Roxadustat inhibits prolyl hydroxylation of HIF-α subunits, preventing their degradation under normoxic conditions.
• Erythropoietin Production: Stabilized HIFs translocate to the nucleus, promoting the transcription of the erythropoietin gene, thereby increasing endogenous EPO levels.
• Iron Metabolism Regulation: Roxadustat influences iron homeostasis by increasing intestinal iron absorption and mobilizing stored iron, enhancing its availability for erythropoiesis.
• Reduction of Inflammatory Cytokines: By modulating HIF pathways, Roxadustat can reduce the levels of inflammatory cytokines that interfere with erythropoiesis.

Indications and Therapeutic Uses

Roxadustat API is utilized in the formulation of medications aimed at treating anemia associated with chronic kidney disease. Its primary therapeutic applications include:

• Anemia in Chronic Kidney Disease (CKD) Patients: Effective in managing anemia in both dialysis-dependent and non-dialysis-dependent CKD patients.
• Iron Metabolism Disorders: Helps in improving iron utilization and availability, reducing the need for intravenous iron supplementation.
• Hypoxia-Related Conditions: Potential use in other hypoxia-related anemic conditions, although primarily approved for CKD-related anemia.

Pharmacokinetics

Understanding the pharmacokinetic profile of Roxadustat is essential for optimizing its therapeutic use and ensuring patient safety.

• Absorption: Roxadustat is well-absorbed from the gastrointestinal tract with peak plasma concentrations reached within 2-4 hours post-administration.
• Distribution: Widely distributed throughout the body, including the central nervous system, due to its lipophilic nature.
• Metabolism: Metabolized in the liver primarily via cytochrome P450 enzymes, particularly CYP2C8 and CYP3A4, leading to the formation of inactive metabolites.
• Excretion: Excreted mainly through renal and fecal pathways, with a minor fraction eliminated unchanged in the urine.
• Half-Life: Approximately 12 hours, allowing for twice-daily dosing regimens to maintain therapeutic plasma levels.

Quality Assurance and Manufacturing Excellence

At Ayurvite Wellness Pvt. Ltd., quality is the cornerstone of our manufacturing philosophy. Our Roxadustat API is synthesized and processed in compliance with the highest international standards, ensuring purity, potency, and safety.

Manufacturing Facilities

Our state-of-the-art manufacturing units are equipped with advanced technologies and operated by a team of experienced chemists and quality control experts. Located in key pharmaceutical hubs, our facilities adhere to stringent Good Manufacturing Practices (GMP) guidelines, ensuring consistent and reliable API production.

Quality Control Measures

• Raw Material Verification: All raw materials undergo rigorous testing to confirm their identity, purity, and compliance with specifications before use.
• In-Process Testing: Continuous monitoring during the synthesis and processing stages ensures adherence to quality parameters and early detection of deviations.
• Final Product Testing: Comprehensive analytical testing, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Infrared (IR) spectroscopy, and dissolution studies, guarantees the API meets all required specifications.
• Stability Testing: Our APIs undergo stability assessments to determine shelf-life and ensure efficacy over time under various storage conditions.

Certifications and Compliance

Ayurvite Wellness Pvt. Ltd. holds multiple certifications attesting to our commitment to quality and regulatory compliance:

• ISO 9001:2015: Demonstrates our dedication to quality management systems.
• cGMP Certification: Confirms our adherence to current Good Manufacturing Practices.
• FDA Approval: Our manufacturing facilities are approved by the U.S. Food and Drug Administration, facilitating seamless export to global markets.
• EU GMP Compliance: Ensures our APIs meet the stringent quality standards required by the European Union.

Regulatory Approvals

Navigating the complex landscape of global pharmaceutical regulations is a testament to our expertise and reliability. Ayurvite Wellness Pvt. Ltd. ensures that our Roxadustat API complies with the regulatory requirements of major markets, including:

• United States (FDA)
• European Union (EMA)
• Japan (PMDA)
• India (DCGI)
• Middle East (SFDA, MFDS)
• South East Asia (BPOM, TGA)

Our comprehensive documentation and quality assurance processes facilitate smooth regulatory approvals, enabling our clients to bring their products to market swiftly and efficiently.

Applications of Roxadustat API

Roxadustat API’s versatile pharmacological profile makes it a valuable ingredient in various pharmaceutical formulations. Key applications include:

• Oral Tablets and Capsules: Widely used in the formulation of oral medications aimed at treating anemia in chronic kidney disease patients.
• Syrups and Solutions: Incorporated into liquid formulations for patients who have difficulty swallowing solid dosage forms, offering easy administration and rapid onset of action.
• Injectable Forms: Utilized in specialized formulations requiring intravenous or intramuscular delivery for acute management of severe anemia.
• Combination Therapies: Employed in multi-API formulations to target multiple symptoms simultaneously, enhancing therapeutic outcomes.
• Extended-Release Formulations: Developed for sustained therapeutic effects and improved patient compliance.

Benefits of Choosing Ayurvite Wellness Pvt. Ltd. for Roxadustat API

Partnering with Ayurvite Wellness Pvt. Ltd. for your Roxadustat API needs offers numerous advantages that set us apart in the pharmaceutical API export sector.

Uncompromising Quality

Our Roxadustat API is manufactured under stringent quality controls, ensuring each batch meets the highest standards of purity and efficacy. We employ advanced analytical techniques and adhere to global quality benchmarks, providing our clients with reliable and consistent API supply.

Competitive Pricing

Understanding the financial dynamics of the pharmaceutical industry, we offer our Roxadustat API at competitive prices without compromising on quality. Our efficient manufacturing processes and economies of scale enable us to deliver cost-effective solutions to our clients.

Global Supply Chain Expertise

With an extensive global distribution network, Ayurvite Wellness Pvt. Ltd. ensures timely and secure delivery of Roxadustat API to any corner of the world. Our logistics team is adept at navigating international shipping regulations, ensuring smooth and hassle-free procurement for our clients.

Customization and Flexibility

We recognize that different clients have unique requirements. Whether it’s specific mesh sizes or customized packaging, we offer flexible solutions to meet your precise needs. Our dedicated R&D team works closely with clients to develop bespoke formulations that align with their product specifications.

Regulatory Support

Navigating regulatory landscapes can be challenging. Our team of regulatory experts provides comprehensive support, assisting clients in obtaining necessary certifications and ensuring compliance with regional and international regulations. This support accelerates the time-to-market for your pharmaceutical products.

Sustainability and Ethical Practices

At Ayurvite Wellness Pvt. Ltd., we prioritize sustainable and ethical manufacturing practices. Our processes are designed to minimize environmental impact, and we adhere to ethical labor standards, ensuring that our operations contribute positively to society and the environment.

Manufacturing Process of Roxadustat API

The synthesis of Roxadustat API involves meticulous processes to ensure the highest quality and efficacy. Below is an overview of our manufacturing process:

Synthesis of Roxadustat Base

1. Raw Material Preparation: High-purity starting materials are selected and subjected to preliminary purification to eliminate impurities.
2. Chemical Synthesis: Roxadustat is synthesized through a multi-step chemical reaction involving the condensation of appropriate precursors under controlled conditions.
3. Purification: The crude Roxadustat base undergoes recrystallization and other purification techniques to achieve the desired purity level.
4. Characterization: The purified base is characterized using analytical techniques such as Nuclear Magnetic Resonance (NMR), Infrared (IR) spectroscopy, and mass spectrometry to confirm its structure and purity.

Formation of Roxadustat API

1. Hydrochloride Salt Formation: The purified Roxadustat base is reacted with hydrochloric acid to form the dihydrochloride salt, enhancing its solubility and stability.
2. Crystallization: The reaction mixture is crystallized to obtain pure Roxadustat Dihydrochloride crystals.
3. Drying and Milling: The crystals are dried under controlled conditions and milled to achieve the desired particle size and consistency.

Quality Control and Assurance

1. Blending: Roxadustat Dihydrochloride is blended to ensure uniform distribution of the API.
2. Final Quality Testing: Comprehensive testing, including assay, purity, and dissolution studies, is conducted to verify that the API meets all specified criteria.
3. Packaging: The finished API is packaged in moisture-proof and contamination-resistant containers, ensuring stability and longevity.

Stability and Shelf Life

Roxadustat API manufactured by Ayurvite Wellness Pvt. Ltd. exhibits excellent stability under recommended storage conditions. Our stability testing ensures that the API maintains its efficacy, potency, and safety over its intended shelf life.

• Storage Conditions: Store in a cool, dry place away from direct sunlight and moisture.
• Shelf Life: Typically, the Roxadustat API has a shelf life of 24 months from the date of manufacture when stored under optimal conditions.

Safety and Handling

Handling Roxadustat API requires adherence to safety protocols to ensure the well-being of personnel and maintain product integrity.

Safety Precautions

• Personal Protective Equipment (PPE): Wear appropriate PPE, including gloves, safety goggles, and lab coats, to prevent direct contact.
• Ventilation: Ensure adequate ventilation in the workspace to avoid inhalation of dust or vapors.
• Storage: Store the API in labeled, secure containers away from incompatible substances.

First Aid Measures

• Inhalation: Move to fresh air immediately. Seek medical attention if symptoms persist.
• Skin Contact: Rinse affected area with plenty of water. Remove contaminated clothing and seek medical advice if irritation occurs.
• Eye Contact: Rinse thoroughly with water for at least 15 minutes and seek medical assistance.
• Ingestion: Rinse mouth and seek medical attention immediately.

Disposal Considerations

Dispose of Roxadustat API and its containers in accordance with local, regional, and national regulations. Avoid releasing the substance into the environment to prevent contamination.

Packaging and Delivery

Ayurvite Wellness Pvt. Ltd. offers flexible packaging solutions tailored to the specific needs of our clients. Our Roxadustat API is available in bulk quantities to facilitate ease of handling and storage.

Packaging Options

• Bulk Packaging: Available in 10 kg, 25 kg, 50 kg, and 100 kg drums for large-scale manufacturing needs.

Delivery Logistics

Our robust logistics network ensures timely and secure delivery of Roxadustat API to any destination worldwide. We collaborate with trusted shipping partners to facilitate efficient transportation, whether by air, sea, or land.

• Documentation: Comprehensive documentation, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory compliance certificates, accompany each shipment.
• Tracking: Real-time tracking options are available to monitor the status of your order from dispatch to delivery.
• Customs Clearance: Our experienced team assists with customs clearance processes to minimize delays and ensure smooth entry into the destination country.

Benefits of Choosing Ayurvite Wellness Pvt. Ltd. for Roxadustat API

Partnering with Ayurvite Wellness Pvt. Ltd. for your Roxadustat API needs offers numerous advantages that set us apart in the pharmaceutical API export sector.

Uncompromising Quality

Our Roxadustat API is manufactured under stringent quality controls, ensuring each batch meets the highest standards of purity and efficacy. We employ advanced analytical techniques and adhere to global quality benchmarks, providing our clients with reliable and consistent API supply.

Competitive Pricing

Understanding the financial dynamics of the pharmaceutical industry, we offer our Roxadustat API at competitive prices without compromising on quality. Our efficient manufacturing processes and economies of scale enable us to deliver cost-effective solutions to our clients.

Global Supply Chain Expertise

With an extensive global distribution network, Ayurvite Wellness Pvt. Ltd. ensures timely and secure delivery of Roxadustat API to any corner of the world. Our logistics team is adept at navigating international shipping regulations, ensuring smooth and hassle-free procurement for our clients.

Customization and Flexibility

We recognize that different clients have unique requirements. Whether it’s specific mesh sizes or customized packaging, we offer flexible solutions to meet your precise needs. Our dedicated R&D team works closely with clients to develop bespoke formulations that align with their product specifications.

Regulatory Support

Navigating regulatory landscapes can be challenging. Our team of regulatory experts provides comprehensive support, assisting clients in obtaining necessary certifications and ensuring compliance with regional and international regulations. This support accelerates the time-to-market for your pharmaceutical products.

Sustainability and Ethical Practices

At Ayurvite Wellness Pvt. Ltd., we prioritize sustainable and ethical manufacturing practices. Our processes are designed to minimize environmental impact, and we adhere to ethical labor standards, ensuring that our operations contribute positively to society and the environment.

Frequently Asked Questions (FAQs)

1. What is Roxadustat API used for?

Roxadustat API is primarily used in the formulation of medications aimed at treating anemia associated with chronic kidney disease (CKD). It helps in stimulating red blood cell production by increasing endogenous erythropoietin levels and improving iron metabolism.

2. Does Ayurvite Wellness Pvt. Ltd. offer custom formulations of Roxadustat API?

Yes, we offer customized formulations to meet specific client requirements, including adjustments in mesh size and customized packaging formats.

3. What certifications does Ayurvite Wellness hold for Roxadustat API?

Our Roxadustat API is manufactured in facilities certified with ISO 9001:2015, cGMP, and holds approvals from regulatory bodies such as the US FDA, EU EMA, Japan PMDA, and more.

4. How does Ayurvite ensure the quality of Roxadustat API?

We implement rigorous quality control measures at every stage of the manufacturing process, including raw material verification, in-process testing, final product analysis, and stability testing to ensure the highest quality standards.

5. What is the typical shelf life of Roxadustat API?

Our Roxadustat API typically has a shelf life of 24 months when stored under recommended conditions—cool, dry places away from direct sunlight and moisture.

6. Can Ayurvite Wellness Pvt. Ltd. handle large-scale bulk orders of Roxadustat API?

Absolutely. Our manufacturing facilities have a total reactor volume exceeding 1200 KL, enabling us to accommodate extensive API requirements for large-scale pharmaceutical productions.

7. What packaging options are available for Roxadustat API?

We offer bulk packaging options in 10 kg, 25 kg, 50 kg, and 100 kg drums, tailored to meet large-scale manufacturing needs.

8. How does Ayurvite manage international shipments of Roxadustat API?

Our experienced logistics team ensures that all international shipments comply with local and international regulations. We provide comprehensive documentation, real-time tracking, and assist with customs clearance to ensure seamless delivery.

9. What safety measures are in place during the manufacturing of Roxadustat API?

Our manufacturing facilities adhere to stringent safety protocols, including the use of Personal Protective Equipment (PPE), proper ventilation systems, and secure storage practices to ensure the safety of our personnel and the integrity of the product.

10. How can I place an order for Roxadustat API with Ayurvite Wellness Pvt. Ltd.?

You can place an order or make an inquiry by visiting our contact page at https://apiexporter.com/contact/. Our customer service representatives will guide you through the ordering process and assist with any specific requirements you may have.

Conclusion

In the realm of pharmaceutical APIs, Ayurvite Wellness Pvt. Ltd. distinguishes itself through an unwavering commitment to quality, regulatory excellence, and customer satisfaction. Our Roxadustat API embodies these values, offering pharmaceutical manufacturers a reliable, high-quality ingredient essential for developing effective and safe anti-anemic medications. Partner with us to leverage our expertise, state-of-the-art facilities, and global reach, ensuring your products meet the highest standards and achieve market success.

For inquiries, quotations, or further information about our Roxadustat API, please visit our contact page at https://apiexporter.com/contact/.