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Suppliers and packagers for hydroxyurea
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hydroxyurea
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Barr | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075143 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0882-02 | 100 CAPSULE in 1 BOTTLE (0555-0882-02) | 1998-10-19 |
| Barr | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075143 | ANDA | AvKARE | 42291-321-01 | 100 CAPSULE in 1 BOTTLE (42291-321-01) | 2013-07-23 |
| Leading | HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 213438 | ANDA | Golden State Medical Supply, Inc. | 51407-909-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (51407-909-01) | 2020-04-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Hydroxyurea
Introduction
Hydroxyurea is a vital chemotherapeutic and disease-modifying agent used primarily in the treatment of conditions such as sickle cell disease, leukemia, melanoma, and other myeloproliferative disorders. Its mechanism involves inhibiting DNA synthesis by targeting ribonucleotide reductase, which disrupts abnormal cell proliferation. The global demand for Hydroxyurea has surged due to its efficacy and expanded applications. Consequently, identifying reliable suppliers is critical for pharmaceutical companies, healthcare providers, and procurement organizations aiming to ensure drug availability, compliance, and quality.
This report provides a comprehensive overview of key suppliers of Hydroxyurea, analyzing their manufacturing capabilities, geographic presence, regulatory compliance, and market footprint.
Manufacturers of Hydroxyurea
1. Hikma Pharmaceuticals
Hikma Pharmaceuticals, a leading global generic pharmaceutical company headquartered in Jordan, supplies Hydroxyurea through its extensive network across North America, Europe, the Middle East, and Africa. Hikma’s manufacturing facility in Portugal adheres to stringent quality standards aligned with EMA and FDA regulations. The company's Hydroxyurea products are widely used in both developed and emerging markets.
2. Mylan (Now Part of Viatris)
Mylan, acquired by Viatris in 2020, ranks among the largest producers of Hydroxyurea worldwide. Its manufacturing facilities in the United States and India ensure high-quality production adhering to FDA and global GMP standards. The company's extensive distribution network facilitates broad accessibility to Hydroxyurea in North America, Europe, and Asia.
3. Sun Pharmaceutical Industries Ltd.
One of the largest Indian pharmaceutical firms, Sun Pharma manufactures Hydroxyurea through its facilities compliant with US FDA, EMA, and Indian regulatory agencies. Its strong footprint in Asia, Africa, and the Middle East makes it a significant supplier, particularly for low-to-middle-income markets.
4. Cipla Limited
Based in India, Cipla is a prominent manufacturer of Hydroxyurea and holds multiple international licenses. Its global distribution spans over 100 countries, including Europe, Africa, and Asia. Cipla maintains robust quality standards, making its Hydroxyurea products competitive on cost and compliance.
5. Otsuka Pharmaceutical
Otsuka is a Japanese pharmaceutical company with a focus on specialty medications. It produces Hydroxyurea for specific indications, particularly sickle cell disease treatment in collaboration with market-specific healthcare systems. Otsuka’s global operations comply with rigorous regulatory standards.
6. Teva Pharmaceutical Industries
Teva, based in Israel, is another leading generic manufacturer with a significant Hydroxyurea portfolio. Their facilities across North America and Europe meet FDA, EMA, and GMP standards. Teva’s broad market coverage makes it a notable Hydroxyurea supplier.
7. Teijin Pharma Limited
Japanese pharmaceutical leader Teijin Pharma produces Hydroxyurea for domestic and international markets, focusing on high-quality standards aligned with Japanese regulations and international GMP protocols. Its strategic partnerships secure access in Asia and emerging markets.
Emerging Suppliers and Market Trends
Several emerging generic manufacturers and regional producers are entering the Hydroxyurea market, driven by increasing demand. These include companies in China, Brazil, and Eastern Europe, offering cost-effective alternatives optimized for local markets. Their regulatory compliance and manufacturing capacity are rapidly evolving as they aim for international registration and distribution.
The Asia-Pacific region, notably India and China, is expected to dominate growth due to manufacturing scale and competitive pricing. These manufacturers benefit from supportive government policies and expanding healthcare coverage.
Regulatory and Quality Considerations
Suppliers must ensure compliance with international and local regulatory standards, notably US FDA, European EMA, Japanese PMDA, and Indian DCGI regulations. Validation of manufacturing processes, rigorous quality control, stability testing, and batch consistency are essential to maintain credibility.
Particularly for drugs like Hydroxyurea, which have a narrow therapeutic window and require precise dosing, quality assurance becomes paramount. Suppliers with robust pharmacovigilance systems and adherence to Good Manufacturing Practices (GMP) minimize risks related to impurities and batch variations.
Market Dynamics and Supply Chain Challenges
The global supply chain for Hydroxyurea faces several challenges:
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Regulatory Compliance: Ongoing registration requirements across different jurisdictions can delay market entry.
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Manufacturing Capacity: Scaling production to meet rising global demand requires significant investment and technology transfer.
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Raw Material Availability: The synthesis of Hydroxyurea depends on specific chemical precursors, susceptible to supply disruptions.
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Intellectual Property and Patent Status: Many formulations are off-patent, facilitating generic manufacturing, but new formulations or combinations may face patent protections.
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Pricing Pressure: Increased competition drives price reductions, impacting profit margins for suppliers.
Conclusions
The Hydroxyurea market is characterized by a mix of established multinational pharmaceutical companies and emerging regional manufacturers. Leading suppliers like Hikma, Viatris (Mylan), Sun Pharma, Cipla, Teva, and Otsuka Suppliers offer high-quality, regulated products, ensuring broad global availability. Continued growth is driven by expanding indications, particularly for sickle cell disease and hematological malignancies, which necessitate reliable supply chains.
Strategic procurement should prioritize regulatory compliance, quality assurance, and supply chain resilience. Partnerships, capacity expansion, and adherence to international standards are essential for suppliers aiming to capitalize on market opportunities.
Key Takeaways
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Diverse Supplier Base: The Hydroxyurea market includes large, established global manufacturers and regional suppliers, ensuring competitive supply across regions.
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Regulatory Vigilance: Compliance with FDA, EMA, and other regulatory frameworks is non-negotiable, influencing supplier credibility and market access.
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Quality Assurance: Rigorous quality controls are essential due to Hydroxyurea’s narrow therapeutic margin and manufacturing sensitivity.
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Emerging Markets: India, China, and Latin American countries are becoming pivotal players with cost-effective manufacturing capacity.
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Supply Chain Risks: Raw material availability, regulatory hurdles, and capacity constraints pose challenges; proactive risk management is advised.
FAQs
1. Who are the top global suppliers of Hydroxyurea?
The leading suppliers include Hikma Pharmaceuticals, Viatris (formerly Mylan), Sun Pharmaceutical Industries, Cipla, Teva Pharmaceuticals, and Otsuka Pharmaceutical, all with manufacturing facilities compliant with international standards.
2. Are generic Hydroxyurea products equivalent to branded versions?
Yes. Hydroxyurea generics are bioequivalent when approved by relevant regulatory agencies such as the FDA and EMA, ensuring similar efficacy and safety profiles.
3. What factors should procurement teams consider when sourcing Hydroxyurea?
Regulatory compliance, manufacturing capacity, quality control measures, pricing, and supply chain stability are critical factors to ensure reliable procurement.
4. How has regional manufacturing impacted Hydroxyurea availability?
Regional manufacturers, especially in India and China, have expanded access through cost-effective production, but require stringent quality oversight to match international standards.
5. What future trends could influence Hydroxyurea supply?
Increasing global demand, technological innovations, and regulatory harmonization are likely to enhance supply stability, while raw material constraints pose ongoing challenges.
Sources:
[1] GlobalData Pharmaceuticals Market Reports, 2022.
[2] FDA Drug Approvals and manufacturing standards overview, 2023.
[3] International Pharmaceutical Regulators Forum (IPRF) guidelines, 2022.
[4] Market analysis reports on generic drug manufacturing, 2023.
[5] Company annual reports and press releases from Hikma, Viatris, Sun Pharma, Cipla, Teva, and Otsuka.
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