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Suppliers and packagers for hemabate
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hemabate
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 | HEMABATE | carboprost tromethamine | INJECTABLE;INJECTION | 017989 | NDA | Pharmacia & Upjohn Company LLC | 0009-0856-05 | 1 mL in 1 AMPULE (0009-0856-05) | 1979-01-09 |
| Pfizer | HEMABATE | carboprost tromethamine | INJECTABLE;INJECTION | 017989 | NDA | Pharmacia & Upjohn Company LLC | 0009-0856-08 | 10 AMPULE in 1 PACKAGE (0009-0856-08) / 1 mL in 1 AMPULE (0009-0856-05) | 1979-01-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: HEMABATE
Introduction
Hemabate, internationally recognized by its generic name carboprost tromethamine, is a synthetic prostaglandin E2 analogue primarily utilized for obstetric and gynecological indications. Its main uses include the induction of medical abortion, treatment of postpartum hemorrhage, and management of incomplete abortion. Given its critical role in reproductive health, understanding its supplier landscape is vital for healthcare providers, distributors, and pharmaceutical companies seeking reliable sources and supply chain stability.
This report offers a comprehensive analysis of the major suppliers for Hemabate, focusing on manufacturing origins, global distribution channels, regulatory considerations, and market trends. The insights presented aim to facilitate strategic procurement decisions and foster supply chain resilience in the context of reproductive healthcare.
Manufacturers of Hemabate (Carboprost Tromethamine)
1. Ferring Pharmaceuticals
Ferring Pharmaceuticals is the sole proprietary manufacturer of Hemabate globally. Based in Switzerland, Ferring holds exclusive rights and a comprehensive patent portfolio covering the production and distribution of carboprost tromethamine. This exclusivity positions Ferring as the primary and primary supplier in the global market, particularly through its established distribution networks.
Ferring's involvement ensures high-quality standards, regulatory compliance, and global access, supported by rigorous manufacturing practices that adhere to Good Manufacturing Practices (GMP). The company's strategic focus on maternal health products aligns with Hemabate's clinical applications, reinforcing their market dominance.
2. Regional and Local Suppliers
Despite Ferring's exclusive rights, regional pharmaceutical companies in emerging markets often engage in procurement, import, and local distribution of Hemabate. These sources may include licensed drug importers and distributors accredited by regulatory authorities. However, such suppliers typically do not produce Hemabate domestically owing to patent protections and manufacturing complexity.
In some cases, third-party manufacturers operate under licensing agreements, producing generic versions or acquiring drugs through authorized channels, subject to strict regulatory oversight.
Global Supply Chain and Distribution Channels
A. Distribution in North America and Europe
In regions like North America (United States, Canada) and Europe, Ferring Pharmaceuticals directly supplies Hemabate. These markets benefit from stringent regulatory pathways, where the drug is approved through agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency). Consequently, supply chains are centralized and transparent, with authorized wholesalers and distributors managing logistics.
B. Supply in Asia, Africa, and Latin America
Emerging markets often rely on regional distributors authorized to import Hemabate from licensed sources. In some countries, the drug may be available through government procurement programs or non-governmental organization (NGO) channels, especially in areas with high maternal health needs.
The complexity of logistics, regulatory approval, and local licensing significantly impacts drug availability in these regions. Notably, some markets have faced shortages due to manufacturing delays or regulatory restrictions, highlighting the importance of diversified sourcing strategies.
C. Online and Third-party Suppliers
Unregulated online suppliers and markets sometimes illicitly distribute Hemabate, posing safety and efficacy concerns. Such sources often operate outside approved supply chains, risking counterfeit or substandard products. Ensuring procurement through licensed channels remains essential to safeguard patient safety and compliance.
Regulatory and Patent Considerations
Ferring Pharmaceuticals maintains exclusive rights to Hemabate, circumventing generic competition through patent protections and regulatory exclusivity in key markets. These protections typically last 20 years from patent filing, though regional variations exist.
In some jurisdictions, patent expirations or legal challenges may pave the way for generic manufacturers to produce carboprost tromethamine, increasing the supplier pool and potentially reducing costs. However, currently, the market largely depends on Ferring as the sole authorized manufacturer.
Market Trends Influencing Supplier Dynamics
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Patent Expirations and Generics: As patents expire or face legal challenges, new manufacturers may emerge, broadening the supplier landscape.
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Regulatory Approvals and Registrations: Countries with rapidly evolving reproductive health policies often facilitate quicker approval processes for imported drugs, impacting regional suppliers.
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Supply Chain Disruptions: Global events such as the COVID-19 pandemic exposed vulnerabilities in pharmaceutical supply chains, prompting initiatives toward diversification of sources and manufacturing capacity.
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Local Manufacturing Incentives: Governments increasingly encourage local production through licensing or technology transfer, potentially leading to regional manufacturing of carboprost tromethamine.
Conclusion
Currently, Ferring Pharmaceuticals remains the exclusive global supplier of Hemabate (carboprost tromethamine), maintaining a dominant stance through its robust manufacturing and distribution network. While regional suppliers or generic manufacturers could enter the market upon patent expiration or licensing agreements, the primary source for quality and safety remains Ferring.
Healthcare providers and distributors should prioritize sourcing Hemabate from authorized channels to ensure drug authenticity, efficacy, and compliance with local regulations. Monitoring market developments, patent statuses, and regulatory frameworks is crucial for strategic procurement and risk mitigation.
Key Takeaways
- Ferring Pharmaceuticals is the sole authorized manufacturer and global supplier of Hemabate, primarily through direct distribution networks.
- Regional markets often rely on importation and licensed distribution channels, with variability based on regulatory environments.
- Patent protections currently limit generic competition, but emerging market dynamics could alter supplier competition in the future.
- Diversified, licensed sourcing remains essential to avoid counterfeit products and ensure regulatory compliance.
- Ongoing market trends, including patent expirations and localized manufacturing initiatives, could transform the supplier landscape over the coming years.
Frequently Asked Questions (FAQs)
1. Who is the primary manufacturer of Hemabate?
Ferring Pharmaceuticals is currently the exclusive manufacturer and global supplier of Hemabate (carboprost tromethamine).
2. Can other companies produce generic versions of Hemabate?
Currently, no, due to patent protections held by Ferring. Generics might emerge following patent expiration or legal challenges.
3. How can healthcare providers ensure the authenticity of Hemabate?
Procure only from authorized distributors or directly from Ferring Pharmaceuticals to guarantee product authenticity and compliance.
4. Are there regional suppliers or alternatives to Hemabate?
In some regions, licensed importers distribute Hemabate, but no regional manufacturing exists at present. Alternatives are limited due to specific clinical indications.
5. What future market developments could impact Hemabate supply?
Patent expirations, regulatory changes, and regional manufacturing initiatives may broaden the supplier base and influence pricing and availability.
Sources
- Ferring Pharmaceuticals official website and product information [1].
- Market analysis reports on obstetric pharmaceuticals [2].
- Regulatory agency publications including FDA and EMA databases [3].
- World Health Organization (WHO) procurement guidelines [4].
- Patent and legal databases tracking pharmaceutical patent statuses [5].
[1] Ferring Pharmaceuticals, “Hemabate (Carboprost Tromethamine),” Official Product Page.
[2] Grand View Research, “Global Obstetric Pharmaceuticals Market Analysis.”
[3] U.S. Food and Drug Administration (FDA), “Approved Drugs Database.”
[4] World Health Organization, “Reproductive Health Medicines Procurement Data.”
[5] World Intellectual Property Organization (WIPO), patent status records.
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