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Suppliers and packagers for generic pharmaceutical drug: AFAMELANOTIDE
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AFAMELANOTIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Clivunel Inc | SCENESSE | afamelanotide | IMPLANT;SUBCUTANEOUS | 210797 | NDA | CLINUVEL INC. | 73372-0116-1 | 1 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASS | 2019-12-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AFAMELANOTIDE
Introduction
In the rapidly evolving landscape of modern pharmaceuticals, sourcing high-quality active pharmaceutical ingredients (APIs) like AFAMELANOTIDE is critical for ensuring drug efficacy, safety, and compliance. AFAMELANOTIDE, a synthetic peptide with promising indications in melanoma treatment and other oncological disorders, has attracted considerable attention from pharmaceutical manufacturers and research entities. This comprehensive analysis details the global suppliers of AFAMELANOTIDE, highlighting their capabilities, regulatory standing, and strategic positioning in the supply chain.
Understanding AFAMELANOTIDE: A Brief Overview
AFAMELANOTIDE is a synthetic peptide analog targeting melanocortin receptors, primarily used in experimental therapies for melanoma and associated conditions. Its complex synthesis, requiring high purity and stringent quality control, positions it among specialized APIs supplied by niche manufacturers with advanced peptide synthesis expertise.
Access to reliable suppliers is vital due to the drug’s intricate manufacturing process that involves solid-phase peptide synthesis, purification via high-performance liquid chromatography (HPLC), and rigorous sterilization standards. Given the scarcity of licensed commercial sources, existing vendors are predominantly high-tier API producers, often operating within regulatory jurisdictions such as the U.S. FDA, EMA, or other stringent authorities.
Global Suppliers for AFAMELANOTIDE
1. Bachem AG
Overview: A leading biotech company specializing in complex peptides and customization of APIs, Bachem AG operates manufacturing sites in Switzerland and the U.S. It has established a foothold in peptide synthesis, offering custom peptide synthesis, quality peptide APIs, and advanced research solutions.
Capabilities:
- Custom synthesis of peptides up to multi-milligram scales to multi-gram quantities.
- Rigorous quality controls aligned with GMP standards.
- Expertise in handling complex peptide sequences with modifications.
Relevance to AFAMELANOTIDE:
While Bachem primarily provides research-grade peptides, their GMP-compliant facilities facilitate production of clinical trial materials, positioning them as a potential supplier or development partner for AFAMELANOTIDE.
2. Polypeptide Group (UK)
Overview:
A prominent peptide API manufacturer, the Polypeptide Group operates multiple facilities dedicated to peptide synthesis, conjugation, and GMP manufacturing. They cater to pharmaceutical companies seeking rare and complex peptides.
Capabilities:
- GMP-certified production, ensuring compliance with international regulatory standards.
- Focused expertise on peptides involved in oncology and immunology.
- Ability to produce both research-grade and clinical-grade APIs.
Relevance to AFAMELANOTIDE:
Given their extensive peptide portfolio, Polypeptide Group is well-positioned to supply AFAMELANOTIDE at various development stages, from preclinical to phase III clinical trials.
3. WuXi AppTec
Overview:
A global Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO), WuXi AppTec offers integrated services in peptide synthesis, API manufacturing, and scale-up.
Capabilities:
- Large-scale GMP production of peptides.
- Advanced analytical and quality assurance infrastructure.
- Experience in manufacturing peptides for oncology indications.
Relevance to AFAMELANOTIDE:
WuXi’s extensive manufacturing capacity makes it a key candidate for mass production of AFAMELANOTIDE, especially for late-stage clinical trials and commercial supply.
4. Novartis and Sanofi (Contract Manufacturing Partners)
Overview:
Major pharmaceutical corporations like Novartis and Sanofi retain partnerships with external peptide manufacturers to produce niche APIs, including specialized peptides for their pipeline drugs.
Capabilities:
- Strict adherence to GMP standards.
- Proven track record in peptide synthesis for therapeutic agents.
- Integration within global supply chain networks.
Relevance to AFAMELANOTIDE:
Although these pharma giants typically develop APIs in-house or via strategic partners, their extensive manufacturing networks could serve as alternative suppliers for AFAMELANOTIDE, contingent on licensing agreements.
5. Emerging Chinese and Indian Manufacturers
Overview:
A notable segment of peptide API production is emerging from China and India, where several Contract Manufacturing Organizations (CMOs) have scaled up capabilities to meet international demand.
Capabilities:
- Cost-effective manufacturing solutions.
- Ability to produce high-volume batches for early-stage clinical development.
Caveats:
Regulatory compliance and quality assurance standards vary, necessitating thorough audits and validation prior to engagement.
Examples:
- Shanghai New Asia Pharmaceutical Co., Ltd. (China) — Focuses on peptide synthesis, with capacity for custom APIs.
- Shapoorji Pallonji Biotech (India) — Offers peptide synthesis with GMP facilities.
Relevance to AFAMELANOTIDE:
While potentially cost-effective, sourcing from these regions requires diligent validation to meet international regulatory requirements.
Regulatory and Quality Considerations
AFAMELANOTIDE’s clinical application mandates APIs manufactured under Good Manufacturing Practice (GMP) standards to ensure safety and efficacy. Suppliers operating under GMP accreditation are generally preferred for clinical trial material and commercial production. Regulatory agency audits and certifications (FDA, EMA, PMDA) serve as key indicators of supplier compliance.
Aside from GMP compliance, suppliers’ analytical validation protocols, stability data, and impurity profiles are critical. As AFAMELANOTIDE is a highly specific peptide, purity levels exceeding 95% and well-documented synthesis processes are non-negotiable.
Supply Chain Challenges and Market Dynamics
Despite the presence of several credible suppliers, the niche nature of AFAMELANOTIDE means supply can be constrained. Factors influencing availability include manufacturing capacity, intellectual property rights, and the proprietary status of synthesis methods.
Emerging biosimilar and peptide manufacturing companies are exploring more efficient synthesis techniques, which could lower costs and expand availability in the future. The potential expiration of patents or exclusivities related to peptide synthesis whitepapers may also facilitate broader supplier entry.
Conclusion
The supply landscape for AFAMELANOTIDE comprises primarily specialized peptide manufacturers with proven GMP capabilities. Established firms like Bachem AG, Polypeptide Group, and WuXi AppTec serve as the most reliable sources for clinical and commercial quantities. While emerging models in China and India offer cost-effective alternatives, regulatory diligence is paramount.
Given the technical complexity, strategic partnerships with reputable suppliers aligned with international standards are recommended for pharmaceutical companies aiming to develop or commercialize AFAMELANOTIDE. Securing diversified supply sources ensures uninterrupted production and mitigates risks associated with supply chain disruptions.
Key Takeaways
- Leading suppliers such as Bachem AG, Polypeptide Group, and WuXi AppTec provide GMP-grade AFAMELANOTIDE, primarily catering to clinical trial and early commercial needs.
- Regulatory compliance, specifically GMP standards, is crucial for quality assurance and approval readiness.
- Emerging manufacturers in China and India present potential cost benefits but require rigorous validation for international standards.
- Supply chain resilience hinges on diversified sourcing, strategic partnerships, and supplier due diligence.
- Future developments may expand the supplier base as synthesis technologies evolve and regulatory barriers decrease.
FAQs
Q1: What factors should influence the choice of supplier for AFAMELANOTIDE?
A1: Quality assurance (GMP compliance), regulatory standing, manufacturing capacity, track record in peptide production, and cost effectiveness.
Q2: Are there licensed commercial sources for AFAMELANOTIDE?
A2: Currently, AFAMELANOTIDE remains investigative and experimental; commercial licensing depends on ongoing clinical development and regulatory approval.
Q3: How can companies verify the quality of AFAMELANOTIDE supplied by a manufacturer?
A3: Through audit reports, independent analytical testing, batch-release documentation, and adherence to international standards like GMP.
Q4: Are Chinese and Indian peptide manufacturers reliable sources for AFAMELANOTIDE?
A4: They can be cost-effective, but require thorough validation and verification to ensure compliance with international quality and regulatory standards.
Q5: What are the key regulatory considerations when sourcing AFAMELANOTIDE?
A5: Ensuring GMP certification, proper documentation, stability profiles, impurity analyses, and supplier audit results aligned with FDA, EMA, or other applicable regulatory requirements.
References
[1] Bachem AG, "Peptide and API Manufacturing Capabilities," Bachem official website.
[2] Polypeptide Group, "GMP Peptide Production," Polypeptide Group website.
[3] WuXi AppTec, "Integrated Peptide Synthesis Services," WuXi official site.
[4] European Medicines Agency, "Guidelines on Good Manufacturing Practice," EMA publications.
[5] International Peptide Consortium, "Peptide synthesis and purity standards," IPC Journal.
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