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Suppliers and packagers for generic pharmaceutical drug: MEMANTINE HYDROCHLORIDE
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MEMANTINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205825 | ANDA | Amneal Pharmaceuticals LLC | 65162-782-03 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-782-03) | 2017-12-22 |
| Amneal Pharms | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205825 | ANDA | Amneal Pharmaceuticals LLC | 65162-782-09 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-782-09) | 2017-12-22 |
| Amneal Pharms | MEMANTINE HYDROCHLORIDE | memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 205825 | ANDA | Amneal Pharmaceuticals LLC | 65162-782-50 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-782-50) | 2017-12-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MEMANTINE HYDROCHLORIDE
Introduction
Memantine hydrochloride is a widely prescribed medication primarily used to manage moderate to severe Alzheimer's disease. Its role as an NMDA receptor antagonist helps reduce neurodegeneration, making it a critical drug in neurodegenerative disease therapeutics. Given its high market demand—driven by an aging global population—identifying reliable suppliers of pharmaceutical-grade memantine hydrochloride is essential for manufacturers, healthcare providers, and stakeholders in the pharmaceutical supply chain. This analysis evaluates key suppliers, their manufacturing capabilities, compliance standards, and supply chain considerations relevant to memantine hydrochloride.
Global Manufacturing Landscape
The production of memantine hydrochloride involves complex synthesis processes requiring high purity standards and rigorous quality control. Top suppliers operate across regions including Asia, Europe, and North America, with a concentration in China, India, and European pharmaceutical hubs. The competitive landscape is characterized by a mix of large-scale API producers, integrated pharmaceutical companies, and specialized chemical manufacturers.
Major Suppliers of Memantine Hydrochloride
1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)
Overview:
Zhejiang Huahai Pharmaceutical is among the leading API manufacturers in China with a broad portfolio covering neurodegenerative pharmaceutical ingredients. Their production facilities are GMP-compliant, with international approvals enhancing export credibility.
Capabilities:
- Large-scale synthesis and supply of memantine hydrochloride (>99% purity).
- Certified for ISO, GMP, and other international standards.
- Supply chain supports global distribution with a focus on North America and Europe.
Strengths:
- Cost competitive due to regional manufacturing efficiencies.
- Proven track record in neuropharmaceutical APIs.
Considerations:
- Potential delays associated with geopolitical trade restrictions or regional outbreaks.
2. Biophore (India)
Overview:
Biophore is an Indian pharmaceutical company recognized for its high-quality neuropharmaceutical APIs, including memantine hydrochloride. They adhere to stringent regulatory standards and have established export channels.
Capabilities:
- GMP-compliant facilities with advanced synthesis capabilities.
- Consistent quality with batch-to-batch reproducibility.
- Ability to customize APIs per customer specifications.
Strengths:
- Competitive pricing and reliable quality.
- Strong regulatory compliance with USFDA, EMA, and other agencies.
Considerations:
- Longer lead times for large orders due to production cycles.
3. Shanghai Yuxin Pharmaceutical Co., Ltd. (China)
Overview:
Specializing in neuroactive compounds, Shanghai Yuxin supplies memantine hydrochloride primarily to North American and European markets. The company emphasizes quality control and research-backed manufacturing.
Capabilities:
- GMP-certified production of high-purity memantine hydrochloride (>99%).
- Extensive R&D infrastructure for process optimization.
Strengths:
- Focused on pharmaceutical-grade APIs with stringent quality assurance.
- Efficacy in meeting supply demands for clinical and commercial purposes.
Considerations:
- Limited production capacity relative to larger Chinese API manufacturers.
4. CordenPharma (Europe)
Overview:
A division of International Flavors & Chemicals Inc., CordenPharma is known for producing high-quality APIs, including memantine hydrochloride, with an emphasis on regulatory compliance and supply reliability.
Capabilities:
- GMP manufacturing with a focus on complex APIs.
- Extensive regulatory dossier support, facilitating approval processes.
Strengths:
- Leadership in quality management standards.
- Reliable supply to the European and North American markets.
Considerations:
- Typically higher costs relative to Asian suppliers due to manufacturing location.
5. Other Notable Suppliers
- Hefei TNJ Chemical Co., Ltd. (China): Produces memantine hydrochloride with GMP compliance, focusing on cost-effective supply.
- Wuxi Biologics and Other Biotech Firms: Engaged primarily in advanced formulations but expanding into API production.
Key Factors in Supplier Selection
Regulatory Compliance:
Suppliers must hold GMP certification and adhere to international quality standards such as ISO, FDA, EMA, and others. This ensures safety, efficacy, and regulatory approval readiness.
Manufacturing Capacity & Lead Time:
Large-scale production capabilities can mitigate supply shortages, particularly in high-demand periods. Suppliers with robust supply chain infrastructure also deliver consistent deliveries.
Quality & Purity Standards:
High purity levels (>99%) with batch consistency are vital. Suppliers should provide detailed certificates of analysis (CoA) and comply with pharmacopoeial standards (USP, EP, JP).
Cost & Logistics:
While price is critical, it must be balanced against quality and regulatory compliance. Logistic considerations include geographic proximity, shipping reliability, and customs clearance.
Regulatory & Political Stability:
Manufacturers operating in politically stable regions are less prone to disruptions, impacting supply continuity.
Supply Chain Considerations and Risks
The global supply chain for memantine hydrochloride is influenced by factors such as geopolitical tensions, trade tariffs, regulatory changes, and raw material availability. The reliance on Asian manufacturers anchors much of the supply, presenting risks related to quality assurance, intellectual property disputes, and regional infrastructure vulnerabilities. Diversification across multiple suppliers in different territories can mitigate these risks.
Emerging Trends and Future Outlook
- Vertical Integration: Some pharmaceutical companies are investing directly into API manufacturing facilities, reducing dependency on third-party suppliers.
- Quality Certification Expansion: Suppliers are increasingly obtaining certifications such as ICH Q7, enhancing global trust.
- Biotech Collaboration: Growing interest in biosynthetic approaches may reshape the supply landscape, emphasizing sustainability and scalability.
- Market Demands: Aging populations and expanding indications may push suppliers to increase capacity and innovate in formulation and delivery mechanisms.
Conclusion
The supply of memantine hydrochloride hinges on stringent quality standards, reliable manufacturing capacity, and regulatory compliance. Key suppliers like Zhejiang Huahai Pharmaceutical, Biophore, Shanghai Yuxin Pharmaceutical, and CordenPharma offer robust options across geographic regions, balancing cost, quality, and reliability. Stakeholders must adopt disciplined supplier evaluation protocols, emphasizing regulatory adherence, manufacturing capacity, and geopolitical stability to ensure uninterrupted supply chains.
Key Takeaways
- Major global suppliers include Zhejiang Huahai (China), Biophore (India), Shanghai Yuxin (China), and CordenPharma (Europe).
- Selection should prioritize GMP compliance, high purity standards, and supply reliability.
- Diversifying suppliers mitigates geopolitical and supply chain risks.
- Emerging manufacturing trends include biotech integration and increased certification standards for enhanced trust.
- Continuous monitoring of regulatory landscapes and geopolitical developments remains essential for supply chain resilience.
FAQs
1. What are the primary regions manufacturing memantine hydrochloride?
Major production occurs in China, India, and Europe, with key suppliers based in Zhejiang, Shanghai, and several European pharmaceutical hubs.
2. How do I assess the quality of a memantine hydrochloride supplier?
Evaluate GMP certifications, purity levels (>99%), batch consistency, and regulatory compliance documentation such as COAs and pharmacopoeial standards.
3. Are there any regulatory considerations when importing memantine hydrochloride?
Yes. Ensure supplier compliance with local regulations like FDA (USA), EMA (Europe), or other relevant agencies, and verify that product certificates meet jurisdiction-specific standards.
4. What are the risks associated with relying on Asian suppliers?
Risks include geopolitical tensions, trade restrictions, logistical delays, and quality control variations. Diversification and supplier audits are recommended.
5. Is there a rise in alternative or biosynthetic sources of memantine hydrochloride?
Currently, most production remains chemical synthesis-based; however, emerging biosynthetic methods are under research, aiming for sustainability and increased scalability in the future.
Sources
[1] Global pharmaceutical APIs market reports.
[2] Zhejiang Huahai Pharmaceutical official website.
[3] Biophore Pharmaceuticals website and regulatory filings.
[4] Shanghai Yuxin Pharmaceutical production and quality standards.
[5] CordenPharma official documentation and industry evaluations.
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