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Suppliers and packagers for generic pharmaceutical drug: CYSTEINE HYDROCHLORIDE
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CYSTEINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660 | NDA | Exela Pharma Sciences, LLC | 51754-1007-1 | 10 mL in 1 VIAL (51754-1007-1) | 2019-05-28 |
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660 | NDA | Exela Pharma Sciences, LLC | 51754-1007-3 | 100 mL in 1 CARTON (51754-1007-3) | 2019-05-28 |
| Exela Pharma | ELCYS | cysteine hydrochloride | SOLUTION;INTRAVENOUS | 210660 | NDA | Exela Pharma Sciences, LLC | 51754-1008-4 | 25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL | 2023-12-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cysteine Hydrochloride
Introduction
Cysteine hydrochloride, an amino acid derivative, is widely utilized in pharmaceutical formulations, nutritional supplements, and cosmetic products. Its applications range from antioxidant therapy to excipient use in injectable formulations. As demand surges, identifying reliable suppliers for cysteine hydrochloride is critical for pharmaceutical manufacturers aiming for quality, compliance, and supply security.
This analysis offers a comprehensive overview of the leading suppliers specializing in cysteine hydrochloride, examining their market presence, quality standards, product offerings, and geographical footprint. It aims to inform stakeholders—manufacturers, procurement professionals, and investors—about strategic sourcing options for this essential amino acid derivative.
Market Overview: Cysteine Hydrochloride in the Pharmaceutical Sector
Cysteine hydrochloride is typically synthesized via chemical or fermentation processes, requiring strict quality control due to its application in sensitive pharmaceutical formulations. Regulatory compliance, such as adherence to USP, EP, or JP standards, remains paramount. The global market for cysteine derivatives has seen diversification in sourcing, with suppliers spanning Asia, Europe, and North America. The reliable procurement of high-purity, GMP-compliant cysteine hydrochloride is vital in minimizing quality risks and ensuring regulatory approval.
Lead Suppliers for Cysteine Hydrochloride
1. CJ CheilJedang (South Korea)
Overview
CJ CheilJedang is one of the largest producers of amino acids globally, including cysteine hydrochloride, with a reputation for high-quality manufacturing aligned with Good Manufacturing Practices (GMP). The company leverages advanced fermentation technology, ensuring consistent purity and compliance with international pharmaceutical standards.
Product Portfolio & Capabilities
- USP-grade cysteine hydrochloride
- Extensive R&D capabilities enabling tailored formulations
- Supply capacity suitable for large-scale pharmaceutical production
Market Presence
CJ CheilJedang exports to North America, Europe, and Asia, with robust supply chains supported by regional manufacturing facilities. Their products comply with major pharmacopeial standards, facilitating regulatory approvals.
2. Evonik Industries (Germany)
Overview
Evonik is a global specialty chemicals leader, with a strong position in amino acid production, including cysteine hydrochloride. The company emphasizes quality control and innovation, aligning its products with pharmaceutical industry needs.
Product Portfolio & Capabilities
- Pharmaceutical-grade cysteine hydrochloride
- Certificates of Analysis (CoA) and strict adherence to GMP
- Extensive distribution network across continents
Market Presence
Evonik supplies primarily to Europe and North America, with expanding markets in Asia. Their commitment to sustainability and quality assurance makes them a preferred supplier for critical applications.
3. Wacker Chemie AG (Germany)
Overview
Wacker Chemie specializes in amino acid manufacturing, offering cysteine hydrochloride produced through proprietary fermentation technology. Their products meet pharmacopeial standards and are frequently used in dietary supplements and injectable drugs.
Product Portfolio & Capabilities
- High-purity cysteine hydrochloride suitable for injectable formulations
- Custom synthesis options for specialty needs
- GMP compliance and thorough documentation
Market Presence
Wacker's global logistics ensure timely delivery to North America, Europe, and Asia. Their emphasis on quality and regulatory compliance positions them as a reliable partner in pharmaceutical sourcing.
4. Ajinomoto Co., Inc. (Japan)
Overview
Ajinomoto is a prominent amino acid manufacturer with a diversified portfolio, including cysteine hydrochloride. Their strategic focus integrates fermentation technology with strict quality standards for pharmaceutical-grade products.
Product Portfolio & Capabilities
- USP, EP, and JP specifications
- Comprehensive quality assurance protocols
- Supply capabilities for large-volume pharmaceutical clients
Market Presence
Their products are distributed worldwide, supported by regional subsidiaries and manufacturing hubs designed to meet global regulatory requirements.
5. Daesang Holdings Co., Ltd. (South Korea)
Overview
Daesang is recognized for its fermentation technology-driven amino acids, including cysteine hydrochloride. The company emphasizes innovative production methods and quality integrity.
Product Portfolio & Capabilities
- Pharmaceutical and nutritional-grade cysteine hydrochloride
- GMP-certified manufacturing processes
- Custom specifications for active pharmaceutical ingredients (APIs)
Market Presence
Daesang supplies primarily within Asia but maintains export arrangements with strategic partners in North America and Europe.
Emerging Suppliers and Regional Players
Alongside established multinational corporations, regional suppliers in China, India, and Eastern Europe are increasingly participating in the cysteine hydrochloride supply chain. Notably, China’s amino acid manufacturing sector has expanded due to cost advantages and growing capacity, although buyers must rigorously vet quality standards and regulatory compliance.
- China-based suppliers like Sannuo Biotech and Anhui Taifeng Biological Technology focus on competitive pricing but must provide comprehensive documentation for pharmaceutical applications.
- Indian manufacturers such as Meryer (Shanghai) chemical Technology Co., Ltd. serve regional markets with increasing attention to GMP standards.
Challenges in Sourcing Cysteine Hydrochloride
- Quality Assurance: Variability in purity levels can impact formulation stability and compliance.
- Regulatory Alignment: Ensuring suppliers meet GMP, USP, EP, or JP standards is essential for pharmaceutical applications.
- Supply Security: Disruptions due to geopolitical factors, pandemic impacts, or raw material shortages necessitate diversified sourcing strategies.
- Pricing Dynamics: Market fluctuations in raw material costs influence pricing structures, especially from high-volume suppliers.
Strategic Sourcing Considerations
- Certification and Compliance: Prioritize suppliers with documented GMP, ISO, and pharmacopeial compliance.
- Capacity Planning: Confirm the supplier's ability to meet projected demand without compromising quality.
- Traceability and Documentation: Ensure robust traceability practices and transparent documentation for regulatory audits.
- Long-term Partnerships: Establish and nurture vendor relationships to secure consistent supply and mutual quality improvements.
- Regional Diversification: Avoid reliance on a single geographic region to mitigate risks associated with localized disruptions.
Conclusion
Securing reliable suppliers for cysteine hydrochloride requires balancing quality standards, regulatory compliance, and supply reliability. Leading global players like CJ CheilJedang, Evonik, Wacker Chemie, Ajinomoto, and Daesang have demonstrated robust capabilities in delivering high-grade products aligned with pharmaceutical needs. Emerging regional suppliers enhance regional diversification but demand strict verification of compliance.
By adopting comprehensive procurement strategies that emphasize quality assurance, regulatory adherence, and risk mitigation, pharmaceutical companies can establish secure, cost-effective supply chains for cysteine hydrochloride, supporting both product efficacy and compliance.
Key Takeaways
- Leadership in Quality: Prioritize suppliers with GMP certification and clear documentation aligning with international pharmacopeial standards.
- Global Footprint: Diversify sourcing across multiple suppliers and regions to mitigate geopolitical and supply chain risks.
- Capacity & Reliability: Choose suppliers with proven capacity and track records supporting pharmaceutical-grade manufacturing.
- Regulatory Alignment: Verify that suppliers can meet specific regulatory requirements pertinent to target markets.
- Strategic Partnerships: Develop long-term relationships for consistent quality, stability in pricing, and supply security.
FAQs
1. What quality standards should I verify when sourcing cysteine hydrochloride?
Ensure products comply with pharmacopeial standards such as USP, EP, or JP, and verify GMP certification to meet pharmaceutical grade requirements.
2. Are regional suppliers suitable for pharmaceutical-grade cysteine hydrochloride?
Regional suppliers can be suitable if they meet stringent quality, safety, and regulatory standards. Rigorous verification of certifications and quality documentation is essential.
3. How can I mitigate supply chain disruptions for cysteine hydrochloride?
Diversify suppliers across regions, establish long-term partnerships, and maintain safety stock to buffer against potential supply interruptions.
4. What are the key considerations for regulatory approval of cysteine hydrochloride?
Compliance with local pharmacopeial standards, comprehensive documentation, and GMP adherence are critical for regulatory approval in pharmaceutical applications.
5. Has the demand for cysteine hydrochloride increased in recent years?
Yes, driven by its expanding use in nutraceuticals, cosmetics, and pharmaceuticals, spurred further by increased health awareness and biopharmaceutical development.
Citations:
[1] Market data from industry reports, supplier websites, and regulatory standards portals.
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