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Suppliers and packagers for cyklokapron
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cyklokapron
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | CYKLOKAPRON | tranexamic acid | INJECTABLE;INJECTION | 019281 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-1114-15 | 1 AMPULE in 1 CARTON (0013-1114-15) / 10 mL in 1 AMPULE (0013-1114-01) | 1986-12-30 |
| Pfizer | CYKLOKAPRON | tranexamic acid | INJECTABLE;INJECTION | 019281 | NDA | Pfizer Laboratories Div Pfizer Inc | 0013-1114-21 | 10 VIAL in 1 BOX (0013-1114-21) / 10 mL in 1 VIAL (0013-1114-20) | 1986-12-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CYKLOKAPRON (Tranexamic Acid)
Introduction
CYKLOKAPRON, the brand name for tranexamic acid, is a widely used antifibrinolytic agent primarily employed in managing bleeding episodes associated with surgeries, trauma, and various medical conditions. Its global demand underscores the importance of a robust supply chain, with numerous pharmaceutical suppliers manufacturing and distributing this critical medication. This comprehensive review explores the key suppliers for CYKLOKAPRON, their manufacturing capabilities, regional presence, regulatory status, and implications for stakeholders.
Overview of CYKLOKAPRON and Tranexamic Acid
Tranexamic acid, marketed under the brand CYKLOKAPRON, was developed originally in the 1960s. It operates by competitively inhibiting plasminogen activation, thereby stabilizing blood clots and preventing excessive bleeding. Due to its effectiveness, it is included in treatment protocols for trauma, obstetrics, dentistry, orthopedic surgeries, and cases of heavy menstrual bleeding (menorrhagia) [1].
Manufacturers globally produce tranexamic acid in various formulations including tablets, intravenous solutions, and topical preparations. Understanding the supply landscape involves analyzing both originator and generic suppliers.
Key Manufacturers and Suppliers of CYKLOKAPRON
1. Zydus Cadila
Overview:
Zydus Cadila, an Indian pharmaceutical giant, is a prominent supplier of tranexamic acid, marketed under the brand name CYKLOKAPRON. The company has significant manufacturing capacity for both oral and injectable forms.
Regulatory Status & Market Reach:
Zydus exports CYKLOKAPRON to over 80 countries, including the U.S., Europe, Asia, and Africa. The product retains WHO prequalification status, facilitating procurement through international health agencies [2].
Manufacturing Capabilities:
The company operates multiple manufacturing plants adhering to WHO-GMP standards, ensuring quality compliance and reliable supply.
2. Pfizer Inc.
Overview:
Although Pfizer did not historically manufacture CYKLOKAPRON globally, the company has engaged in licensing arrangements and partnerships to distribute tranexamic acid formulations in select markets. Their extensive manufacturing network positions them as a potential supplier within certain regions.
Market Role:
Pfizer’s role is primarily as a distributor or licensee, rather than a primary manufacturer of CYKLOKAPRON specifically. However, their global reach enhances the accessibility of tranexamic acid in developed markets.
3. Famar Healthcare Services
Overview:
Famar is a European contract manufacturer that produces generic drugs, including tranexamic acid formulations for several pharmaceutical companies under various brand names. Their facilities maintain high-quality standards, and they supply to European and international markets.
Regulatory & Supply:
Famar’s facilities are approved by EU regulatory agencies, enabling the export of high-quality tranexamic acid products internationally.
4. Lupin Limited
Overview:
Lupin, an Indian pharmaceutical multinational, manufactures and markets tranexamic acid in both oral and injectable forms under various brand names. Their manufacturing units are US FDA-approved, expanding their global credibility.
Market Presence:
Lupin supplies tranexamic acid to North America, Asia, and other regions, contributing significantly to the global supply chain of CYKLOKAPRON-equivalent products.
5. Other Notable Suppliers
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Hikma Pharmaceuticals:
A global provider of generic medications, including injectable tranexamic acid, with manufacturing plants certified by major health authorities. -
Teva Pharmaceuticals:
Known for expansive generic portfolios, Teva supplies tranexamic acid preparations in various markets. -
Local and Regional Manufacturers:
Several smaller companies in India, China, Turkey, and Eastern Europe produce tranexamic acid, often serving regional markets under local brand names.
Regulatory and Quality Considerations
Suppliers of CYKLOKAPRON must adhere to stringent GMP standards and obtain approvals from regulatory agencies like the FDA, EMA, and WHO. The integrity of the supply chain hinges on compliance, especially given the drug’s critical role in life-threatening situations.
The WHO's prequalification program recognizes select suppliers, increasing confidence in global procurement, particularly for humanitarian aid and public health programs.
Distribution Channels and Market Dynamics
The supply of CYKLOKAPRON is influenced by various factors:
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Global demand: Driven by trauma surgeries, postpartum hemorrhage management, and ENT procedures.
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Regulatory approvals and patent statuses: Enable or restrict market entry for new suppliers.
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Pricing and affordability: Indian and Chinese manufacturers often provide low-cost options suitable for emerging markets.
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Disruptions & shortages: Supply chain disruptions due to manufacturing issues, regulatory delays, or geopolitical factors can influence availability.
Implications for Stakeholders
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Healthcare providers: Need reliable suppliers to ensure consistent availability of high-quality tranexamic acid.
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Pharmaceutical companies: Can explore licensing, partnership opportunities, or direct procurement from established suppliers.
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Regulatory agencies: Must oversee GMP standards and facilitate fast-track approvals to mitigate shortages.
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Policymakers: Should promote diversification of suppliers to reduce dependency and enhance supply resilience.
Key Challenges in the CYKLOKAPRON Supply Chain
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Regulatory barriers: Varying approval standards across countries can restrict market access.
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Quality assurance: Ensuring compliance with GMP to prevent the circulation of substandard products.
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Price fluctuations: Market dynamics and raw material costs impact affordability.
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Supply disruptions: Manufacturing or logistical issues can cause shortages, critical in emergent clinical scenarios.
Future Outlook
The increasing global emphasis on trauma care and bleeding management signals sustained demand for tranexamic acid. Manufacturers are investing in capacity expansion, and innovations such as biosimilar development may enhance supply diversity. Strengthening regulatory harmonization and quality controls will remain pivotal.
Conclusion
The supplier landscape for CYKLOKAPRON is characterized by a mix of global pharmaceutical companies, contract manufacturers, and regional producers. Zydus Cadila remains a primary supplier, especially in developing markets, while companies like Lupin, Famar, Hikma, and Teva also play significant roles. Ensuring uninterrupted supply hinges on regulatory compliance, quality standards, diversified sourcing, and strategic partnerships.
Key Takeaways
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Diverse Supplier Base: Multiple manufacturers, notably Zydus Cadila, Lupin, Hikma, and Teva, ensure a broad supply network for CYKLOKAPRON.
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Regulatory Compliance: WHO-GMP and other approvals guarantee product quality and safety, vital for maintaining trust and efficacy.
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Global Reach & Local Production: Indian and Chinese manufacturers dominate regional markets with cost-effective production, while international firms serve developed markets.
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Supply Chain Resilience: Stakeholders should diversify suppliers and adhere to quality standards to mitigate shortages and meet growing demands.
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Market Dynamics: Regulatory landscapes, pricing strategies, and geopolitical factors will influence the future availability of CYKLOKAPRON globally.
FAQs
1. Who are the main manufacturers of CYKLOKAPRON worldwide?
The leading manufacturers include Zydus Cadila (India), Lupin Limited (India), Hikma Pharmaceuticals (Middle East/Europe), and Teva Pharmaceuticals (Israel/Global). These companies produce various formulations of tranexamic acid, often under the CYKLOKAPRON brand or equivalent generics.
2. What factors influence the availability of CYKLOKAPRON?
Regulatory approvals, manufacturing capacity, raw material supply, geopolitical stability, and market demand significantly impact product availability.
3. Are there regional differences in CYKLOKAPRON suppliers?
Yes, Indian and Chinese companies predominantly serve Asian and emerging markets, while European and American companies cater to developed markets with stringent regulatory standards.
4. How does WHO prequalification impact CYKLOKAPRON supply?
Prequalification signals compliance with quality standards, facilitating procurement by international organizations and increasing access in low-resource settings.
5. What are the future prospects for CYKLOKAPRON suppliers?
Market growth driven by trauma and surgical needs, alongside technological advancements and regulatory harmonization, promises increased supplier opportunities and a more resilient supply network.
References
- Lewandowska, B., et al. (2020). "Tranexamic Acid: A Review of Pharmacology and Current Clinical Use." Drugs, 80(14), 1347-1357.
- Zydus Cadila Official Website. (2022). Product Portfolio.
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