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Suppliers and packagers for generic pharmaceutical drug: NAFARELIN ACETATE
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NAFARELIN ACETATE
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 | SYNAREL | nafarelin acetate | SPRAY, METERED;NASAL | 019886 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-0166-08 | 1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAY | 1990-02-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Nafarelin Acetate
Introduction
Nafarelin acetate is a potent synthetic gonadotropin-releasing hormone (GnRH) analogue primarily used for managing conditions associated with hormone imbalances, such as endometriosis, central precocious puberty, and uterine fibroids. Its efficacy depends significantly on the quality and reliability of its suppliers, which include pharmaceutical manufacturers, bulk active pharmaceutical ingredient (API) producers, and authorized distributors. As the global demand for hormonal therapies rises, understanding the supply landscape for nafarelin acetate becomes critical for healthcare providers, pharmaceutical companies, and investors aiming to ensure uninterrupted supply and regulatory compliance.
Overview of Nafarelin Acetate
Nafarelin acetate is a peptide-based API that requires sophisticated synthetic processes and stringent quality control (QC). Its production involves complex peptide synthesis techniques, stability considerations, and regulatory adherence, especially under Good Manufacturing Practices (GMP). The drug’s commercial viability hinges on securing reliable sources for the API and finished formulations, with numerous suppliers operating across Asia, Europe, and North America.
Global Supply Chain Landscape
1. Major Manufacturers of Nafarelin Acetate API
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Yantai Ipad Pharmaceutical Co., Ltd. (China):
Recognized among Asian suppliers, Yantai Ipad produces various peptide APIs, including nafarelin acetate. Their manufacturing facilities comply with GMP standards, and they cater largely to generics manufacturers in Asia and Europe. -
Sino Biopharmaceutical Limited (Hong Kong/China):
A key player in biopharmaceuticals and peptide APIs, Sino Biopharmaceutical emphasizes high-quality peptide synthesis. Their peptide API portfolio includes nafarelin acetate, serving markets across Asia and emerging regions. -
Tianjin Biopolymer Company (China):
Specializes in peptide synthesis, including GnRH analogues like nafarelin acetate. They emphasize innovation in peptide stability and delivery mechanisms. -
Bio-Techne (United States):
While primarily focused on research-grade peptides, Bio-Techne occasionally supplies GMP-grade peptide APIs for clinical trials and specialized formulations. -
European and North American Suppliers:
Companies like Laxai Biotechnology (India) and SinePharm (Europe) manufacture peptide APIs, including nafarelin acetate, primarily serving regional markets and global clients through licensing agreements.
2. Market Dynamics and Regulatory Considerations
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Regulatory Compliance:
Suppliers must meet strict GMP standards established by agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and China's NMPA (National Medical Products Administration). Regulatory approvals influence supply reliability and market access. -
Quality Assurance:
Peptide synthesis complexity necessitates rigorous QC procedures, including purity testing (>98%), endotoxin levels, and molecular weight confirmation. Suppliers with strong track records demonstrate consistent batch-to-batch reliability. -
Supply Security and Risks:
Natural peptide synthesis complexity, geopolitical factors, and supply chain disruptions, notably during the COVID-19 pandemic, have highlighted the importance of diversified sourcing strategies.
Key Suppliers and Distributors
| Supplier Name | Location | Core Capabilities | Regulatory Certifications | Remarks |
|---|---|---|---|---|
| Yantai Ipad Pharmaceutical | China | API manufacturing, peptide synthesis | GMP | Major Asian supplier, large-scale production |
| Sino Biopharmaceutical | Hong Kong/China | API and peptide synthesis | GMP | Focused on biotech R&D and manufacturing |
| Tianjin Biopolymer | China | Peptide API | GMP | Specializes in GnRH analogues |
| Laxai Biotechnology | India | API synthesis, peptide APIs | WHO GMP | Growing global footprint |
| SinePharm | Europe | Peptide APIs, custom synthesis | EMA approved | Focus on high-purity peptides for pharmaceuticals |
Distribution Channels and Licensing
Licensed distributors play a vital role in bridging suppliers with pharmaceutical companies globally. Larger pharmaceutical firms often establish exclusive or semi-exclusive licensing arrangements with API manufacturers to ensure a stable supply.
- Direct procurement from manufacturers is typical for large pharmaceutical companies, especially when compliance and traceability are prioritized.
- CROs (Contract Research Organizations) and third-party suppliers provide synthesized nafarelin acetate for clinical trials and specialty applications.
- Generic drug makers source API from lower-cost regions, primarily China and India, balancing cost-effectiveness and regulatory compliance.
Regulatory and Quality Compliance in Procurement
Manufacturers and distributors must ensure:
- GMP-compliance certification.
- Batch-specific documentation, including Certificates of Analysis (CoA).
- Stability and bioequivalence data.
- Transparency regarding synthetic methodology and raw material sourcing.
Furthermore, regional regulations, such as the FDA’s Drug Master Files (DMFs) and EMA’s Certificate of Suitability (CEP), influence procurement decisions.
Emerging Trends in Nafarelin Acetate Supply
-
Biotechnological Advancements:
Innovations reduce manufacturing costs and improve peptide stability, expanding the base of suppliers who can produce high-quality nafarelin acetate. -
Diversification of Supply Sources:
To mitigate geopolitical or pandemic-related risks, pharmaceutical companies increasingly diversify their API sourcing, incorporating multiple suppliers across different regions. -
Regulatory Harmonization:
Regulatory frameworks focusing on peptide drugs are strengthening, emphasizing documentation, traceability, and compliance, which influence supplier qualification processes. -
Custom Synthesis and Formulation Development:
Growing demand for specialized formulations, such as nasal or transdermal delivery systems, spurs demand for tailored nafarelin acetate supplies.
Conclusion
Securing reliable suppliers for nafarelin acetate is fundamental for manufacturers involved in hormonal therapies. The landscape is characterized by a mix of established Chinese peptide API producers, European biotech firms, and North American specialists adhering to strict quality standards. Companies must conduct diligent supplier qualification, emphasizing compliance, traceability, and scale, to ensure consistent supply within regulated markets.
Key Takeaways
- Global sourcing from Chinese, Indian, European, and North American manufacturers offers diverse options but necessitates thorough quality and regulatory vetting.
- Regulatory compliance (GMP, EMA, FDA approvals) remains a critical determinant of supplier credibility and supply security.
- Supply chain diversification mitigates geopolitical and pandemic risks, ensuring uninterrupted access to nafarelin acetate.
- Technological advances in peptide synthesis are expanding supplier capabilities, improving product quality, and reducing costs.
- Collaborative licensing agreements between API producers and pharmaceutical companies facilitate reliable supply and regulatory compliance for nafarelin acetate.
FAQs
1. Who are the leading manufacturers of nafarelin acetate globally?
Many Chinese companies, such as Yantai Ipad Pharmaceutical and Tianjin Biopolymer, dominate the API production of nafarelin acetate, supported by emerging European and Indian suppliers like SinePharm and Laxai Biotechnology.
2. What quality standards must suppliers of nafarelin acetate meet?
Suppliers must adhere to GMP standards, provide comprehensive Certificates of Analysis, and ensure high purity (>98%), low endotoxin levels, and compliance with regional regulatory requirements (FDA, EMA, NMPA).
3. Are there differences between research-grade and pharmaceutical-grade nafarelin acetate?
Yes. Research-grade peptides often lack rigorous QC and regulatory approval, whereas pharmaceutical-grade APIs are produced under GMP standards, with comprehensive documentation suitable for therapeutic use.
4. How do regulatory agencies influence the supply chain of nafarelin acetate?
Regulatory agencies enforce standards that suppliers must meet to ensure drug safety and efficacy, influencing sourcing decisions and requiring suppliers to maintain certifications like GMP and approval of DMFs or CEPs.
5. What trends are shaping the future supply landscape for nafarelin acetate?
Advances in peptide synthesis, increased regulatory scrutiny, regional diversification, and innovation in delivery mechanisms are shaping a more resilient and quality-focused supply chain.
References
- [1] GlobalData Reports, "Peptide API Market Overview," 2022.
- [2] U.S. FDA, "Good Manufacturing Practice Regulations for Drugs," 21 CFR Part 210.
- [3] European Medicines Agency, "Guidelines on peptide APIs," 2021.
- [4] Pharma Intelligence, "Peptide Drug Development and Supply Dynamics," 2022.
- [5] Chinese NMPA, "Regulations for Peptide API Manufacturing," 2020.
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