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Suppliers and packagers for kinevac
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kinevac
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bracco | KINEVAC | sincalide | POWDER;INTRAVENOUS | 017697 | NDA | Bracco Diagnostics Inc. | 0270-0556-15 | 10 VIAL in 1 PACKAGE (0270-0556-15) / 5 mL in 1 VIAL | 1976-07-21 |
| Bracco | KINEVAC | sincalide | POWDER;INTRAVENOUS | 017697 | NDA | Fresenius Kabi USA, LLC | 63323-579-05 | 10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01) | 2023-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Kinevac
Introduction
Kinevac, a brand name for the synthetic gonadotropin-releasing hormone (GnRH), primarily contains the active ingredient gonadorelin (also known as factrel or factrelin). It is used diagnostically to evaluate the function of the pituitary gland and in certain fertility treatments. Given its specialized role in reproductive health, Kinevac production depends on a limited number of pharmaceutical suppliers with expertise in peptide synthesis, biological manufacturing, and regulatory compliance. This article explores the key suppliers involved in the manufacturing, distribution, and supply chain of Kinevac, analyzing their roles, market positions, and the implications for stakeholders in the pharmaceutical industry.
Manufacturers of Active Pharmaceutical Ingredient (API): Gonadorelin
1. Ferring Pharmaceuticals
Ferring Pharmaceuticals is the original developer of Kinevac, with a long-standing history dating back to its initial FDA approval in 1984. They manufacture the proprietary gonadorelin peptide, ensuring high purity and strict compliance with Good Manufacturing Practices (GMP). As a global leader in reproductive health, Ferring supplies Kinevac to a wide network of distributors and healthcare providers worldwide. Their manufacturing facilities are certified by regulatory agencies such as the FDA and EMA, supporting consistent quality standards.
2. Peptide Suppliers and Contract Manufacturers
Several contract manufacturing organizations (CMOs) specialize in peptide synthesis, offering gonadorelin as a custom or commercial API. These include:
- Polypeptide Group (United Kingdom): Specializes in peptide synthesis with facilities capable of GMP production for hormonal peptides, including gonadorelin.
- Bachem (Switzerland): Offers custom peptide synthesis services and may supply gonadorelin API for specific markets or research purposes.
- Aname (China): Provides peptide synthesis services with competitive pricing, although quality assurance and regulatory compliance vary.
While these organizations may produce gonadorelin, Ferring remains the primary commercial source for pharmaceutical-grade gonadorelin used in Kinevac, given their established regulatory and quality standards.
Distribution and Supply Chain Partners
3. Distributors and Wholesalers
Kinevac distribution is managed through a network of authorized pharmaceutical distributors worldwide. Major global pharmaceutical distributors include:
- McKesson Corporation (USA): Supplies Kinevac to hospitals and clinics across North America.
- LINGO (Europe): Provides access to Kinevac across European healthcare markets in compliance with local regulations.
- Meitheal Pharmaceuticals (Ireland): Distributes neonatal and reproductive health pharmaceuticals within Europe, including Kinevac.
These distributors ensure the drug reaches hospitals, clinics, and compounding pharmacies. Their role is critical in maintaining the integrity, temperature control, and timely delivery of Kinevac.
4. Regional and Specialty Suppliers
In certain markets, local suppliers or regional distributors may serve as intermediaries, especially in emerging markets where direct access from the original manufacturer may be limited. These suppliers often source from the primary distributors or regional offices of Ferring Pharmaceuticals, ensuring compliance with local regulatory requirements.
Regulatory and Licensing Authorities
Manufacturers and suppliers of Kinevac must navigate stringent regulatory landscapes, including approvals from agencies such as:
- U.S. Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Health Canada
- Pharmaceuticals and Medical Devices Agency (PMDA, Japan)
These bodies authorize the production and distribution of gonadorelin-based products, emphasizing quality, safety, and efficacy. Suppliers must maintain compliant manufacturing practices to sustain licensing and market access.
Market Dynamics and Challenges
Limited Supplier Pool
Given the specialized nature of peptide synthesis, the pool of reliable, high-quality suppliers for gonadorelin API remains small. This limited competition can affect drug pricing and supply chain resilience. Additionally, patent protections and licensing agreements influence market entry for generic or biosimilar versions, whose availability could shift the supplier landscape.
Supply Chain Risks
Peptide synthesis involves complex manufacturing processes with strict stability requirements. Disruptions in raw material supply, manufacturing delays, or regulatory hurdles can impact global availability. The COVID-19 pandemic exposed vulnerabilities in pharmaceutical supply chains, emphasizing the need for diversified sourcing strategies.
Potential for Biosimilars and Generics
While Ferring is a dominant supplier, some companies seek to develop biosimilar versions of gonadorelin, potentially expanding the supplier base and improving access. Regulatory pathways for biosimilars vary by jurisdiction, influencing market entry timelines.
Future Outlook
Advancements in peptide synthesis technologies, including automation and continuous manufacturing, are poised to reduce costs and increase production capacity. Companies investing in such innovations could emerge as new suppliers, challenging existing market leaders. Additionally, regional manufacturing hubs in Asia and Eastern Europe are likely to increase local supply, reducing reliance on Western producers.
The increasing demand for reproductive diagnostic agents, particularly in emerging markets, underscores the importance of supply chain robustness and regulatory harmonization. Stakeholders must monitor the development of biosimilars and the expansion of contract manufacturing capabilities to anticipate market shifts.
Key Takeaways
- Primary Supplier: Ferring Pharmaceuticals remains the dominant producer of gonadorelin API used for Kinevac, owing to their established manufacturing expertise and regulatory compliance.
- Manufacturing Complexity: Peptide synthesis requires specialized facilities, limiting the number of high-quality suppliers capable of meeting pharmaceutical standards.
- Distribution Network: Global distributors maintain essential roles in ensuring Kinevac reaches healthcare providers efficiently and safely.
- Market Dynamics: The limited supplier pool and stringent regulatory landscape influence drug availability, pricing, and potential biosimilar development.
- Future Trends: Technological innovations and regional manufacturing hubs will shape the supply landscape by expanding capacity and diversification.
FAQs
1. Who are the main manufacturers of gonadorelin for Kinevac?
Ferring Pharmaceuticals is the primary manufacturer of the gonadorelin API used in Kinevac, supported by contract peptide producers like Polypeptide Group and Bachem in specific markets.
2. Are there generic or biosimilar versions of Kinevac available?
Currently, no widely approved generic versions exist. However, biosimilar development is ongoing, which may influence future market competition.
3. How does supply chain risk impact Kinevac availability?
Supply chain disruptions—such as raw material shortages, manufacturing delays, or regulatory hurdles—can impact availability, especially given the limited number of API producers.
4. What role do regional distributors play in Kinevac supply?
They ensure timely delivery to healthcare providers, maintain regulatory compliance locally, and often serve as the bridge between primary manufacturers and end-users.
5. Will technological advancements expand the supplier base?
Yes, innovations in peptide manufacturing and regional synthesis hubs are expected to increase supply options, potentially improving access and reducing costs.
Sources:
[1] Ferring Pharmaceuticals official website.
[2] European Medicines Agency (EMA) dossier for gonadorelin.
[3] Peptide synthesis industry reports.
[4] Global pharmaceutical distribution networks.
[5] Industry analyses on peptide drug manufacturing and supply chains.
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