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Suppliers and packagers for aveed
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aveed
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Endo Operations | AVEED | testosterone undecanoate | INJECTABLE;INTRAMUSCULAR | 022219 | NDA | Endo USA, Inc. | 67979-511-43 | 1 VIAL, SINGLE-USE in 1 CARTON (67979-511-43) / 3 mL in 1 VIAL, SINGLE-USE | 2014-03-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Aveed (Testosterone Undecanoate)
Introduction
Aveed (also known by its generic name, testosterone undecanoate) is a long-acting injectable testosterone therapy designed primarily for testosterone replacement therapy (TRT) in adult males with hypogonadism. Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, Aveed has become a significant pharmaceutical product within the androgen replacement sector. The drug’s supply chain involves multiple stakeholders, including raw material suppliers, manufacturing organizations, and distributors. This article systematically examines current suppliers involved in Aveed’s production and distribution ecosystem, emphasizing their roles, market positioning, and significance within the global pharmaceutical supply chain.
Active Pharmaceutical Ingredient (API) Suppliers
The core component of Aveed is testosterone undecanoate, an esterified form of testosterone that enables prolonged release. The quality and purity of the API are paramount; hence, reputable API manufacturers are critical to Aveed’s supply chain.
1. Recipharm
Recipharm, a Swedish-based contract manufacturing organization (CMO), supplies pharmaceutical-grade testosterone undecanoate. The company is recognized for its high-quality APIs and large-scale production capacity, catering to multiple global markets.
2. Polpharma
A leading pharmaceutical manufacturer based in Poland, Polpharma produces testosterone undecanoate for various formulations, including injectable forms. Its extensive R&D and manufacturing infrastructure support the consistent supply of high-grade API.
3. SK Biotek
South Korea's SK Biotek supplies raw materials and intermediates, including testosterone esters. Their manufacturing facilities adhere to cGMP standards, emphasizing quality and scalability.
4. Bayer
Though traditionally a major player in hormone production, Bayer supplies certain testosterone esters in the form of finished APIs for their formulations. Their involvement is relatively limited concerning Aveed, but their role remains significant in the testosterone API market.
Manufacturers of Aveed
1. Kaleo Pharma
Kaleo Pharma is the original developer and manufacturer of Aveed (testosterone undecanoate injectable), leveraging its expertise in hormone therapies. Kaleo's manufacturing facilities comply with cGMP standards, ensuring high-quality production.
2. CMOs and Contract Manufacturers
Due to patent and complex manufacturing considerations, various CMOs may be engaged to produce Aveed using APIs supplied by specialized API manufacturers. These CMOs operate under strict regulatory oversight, ensuring compliance with international standards.
Distribution and Supply Chain Partners
After manufacturing, Aveed's distribution involves several key players:
1. End-Distributors
Major pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen distribute Aveed to hospitals, specialty clinics, and pharmacies across multiple regions. These distributors handle logistics, storage, and regulatory compliance.
2. Regional and International Distributors
In markets outside the U.S., Aveed is supplied through regional distributors aligned with Kaleo’s global strategy. These partners ensure reaching markets with local regulatory adherence and supply chain security.
Regulatory and Quality Assurance Roles
The development and supply chain of Aveed are heavily regulated:
- FDA and EMA Approvals: Kaleo Laboratories maintains strict compliance with the Food and Drug Administration (FDA) and European Medicines Agency (EMA), which oversee Good Manufacturing Practice (GMP) standards.
- Inspection and Compliance: API manufacturers and contract manufacturers undergo routine inspections and audits to uphold quality and safety standards.
Emerging Trends and Challenges
With increasing demand, supply chain disruptions, and regulatory scrutiny, the landscape of Aveed’s suppliers faces evolved challenges:
- Supply Chain Diversification: To mitigate risks linked to reliance on a single API source, Kaleo and other stakeholders explore diversified API sourcing.
- Sustainability and Ethical Sourcing: Increasing focus on environmentally sustainable practices influences API manufacturers’ operations.
- Regulatory Harmonization: International standards aim to streamline approval and manufacturing processes across jurisdictions.
Conclusion
The supply chain for Aveed represents a complex network of high-quality API producers, specialized manufacturers, and reliable distribution channels. Reputable API suppliers like Recipharm, Polpharma, and SK Biotek play critical roles in ensuring the drug’s quality and availability. With evolving industry standards and market dynamics, diversification and compliance remain central to secure and sustainable Aveed supply.
Key Takeaways
- API sourcing is pivotal: Testosterone undecanoate's quality hinges on reputable manufacturers like Recipharm and Polpharma.
- Manufacturing complexity: Kaleo Pharma oversees the final formulation, supplemented by contract manufacturers and CMOs.
- Distribution networks: Major wholesalers distribute Aveed across regions, emphasizing supply chain resilience.
- Regulatory oversight: High standards from FDA, EMA, and other agencies ensure product safety and quality.
- Market adaptability: Sourcing diversification and regulatory compliance are strategic priorities for stakeholders.
FAQs
1. Who are the primary suppliers of testosterone undecanoate used in Aveed?
Leading API suppliers include Recipharm, Polpharma, and SK Biotek, each providing pharmaceutical-grade testosterone undecanoate used in Aveed production.
2. Can alternative suppliers produce Aveed if the primary suppliers face shortages?
Yes, manufacturing partnerships with other GMP-compliant API producers are designed to enable supply continuity. Such diversification mitigates risks associated with supply disruptions.
3. How does regulatory oversight impact Aveed’s supply chain?
Strict adherence to FDA, EMA, and international standards ensures API quality and manufacturing practices, safeguarding product consistency and safety.
4. Are there any recent innovations in Aveed’s manufacturing process?
Advancements focus on optimizing API synthesis, improving formulation stability, and implementing sustainable manufacturing practices, driving efficiency and compliance.
5. What are the challenges in sourcing ingredients for Aveed?
Global supply chain disruptions, geopolitical factors, and regulatory complexities pose challenges in sourcing high-quality testosterone undecanoate, necessitating strategic planning and diversification.
References
[1] U.S. Food and Drug Administration. (2014). Aveed (Testosterone Enanthate) Approval Announcement.
[2] Kaleo Pharmaceuticals. (2022). Aveed Product Information and Manufacturing Details.
[3] Recipharm. (2023). API Manufacturing Capabilities and Standards.
[4] Polpharma. (2023). Testosterone Undecanoate Production Overview.
[5] EMA. (2022). Regulatory Standards for Hormonal Therapies.
Note: The detailed landscape of Aveed’s suppliers continually evolves with industry developments, regulatory changes, and market demands.
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