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Suppliers and packagers for generic pharmaceutical drug: ARGININE HYDROCHLORIDE
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ARGININE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | R-GENE 10 | arginine hydrochloride | INJECTABLE;INJECTION | 016931 | NDA | Pharmacia & Upjohn Company LLC | 0009-0436-01 | 1 CONTAINER in 1 CARTON (0009-0436-01) / 300 mL in 1 CONTAINER | 1976-06-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Arginine Hydrochloride
Introduction
Arginine hydrochloride is a water-soluble form of the amino acid arginine, often used in medical and pharmaceutical applications including parenteral nutrition, diagnostic substances, and research. As demand for high-quality arginine hydrochloride grows, identifying reliable suppliers is crucial for pharmaceutical companies, healthcare providers, and research institutions. This report offers a comprehensive overview of key suppliers, highlighting their capacities, certifications, and market positioning.
Global Market Overview of Arginine Hydrochloride Suppliers
The supply chain for arginine hydrochloride is characterized by a few prominent chemical manufacturers and intermediaries who specialize in bulk production of amino acids. These suppliers predominantly serve pharmaceutical and nutritional sectors, emphasizing quality assurance, strict GMP compliance, and regulatory certifications such as cGMP, ISO, and USP compliance. The primary sources originate from Asia-Pacific, Europe, and North America, with Asian manufacturers largely dominating due to cost efficiencies.
Major Suppliers of Arginine Hydrochloride
1. Ajinomoto Co., Inc.
Company Profile
Ajinomoto stands as a leading global producer of amino acids and specialty chemicals. Their expertise in fermentation technology places them among the top suppliers of pharmaceutical-grade amino acids, including arginine hydrochloride.
Product Range & Capabilities
- Pharmaceutical Grade: Ajinomoto supplies high-purity, USP-grade arginine hydrochloride suitable for injectable preparations.
- Production Capacity: The company has extensive fermentation facilities capable of multi-ton annual output, ensuring supply for large-scale pharmaceutical manufacturing.
- Certifications: GMP, ISO 9001, ISO 22000, and relevant pharmaceutical certifications.
Market Position
Ajinomoto’s highly regulated production facilities and global distribution network make them a preferred partner for pharmaceutical companies looking for consistent, regulatory-compliant arginine hydrochloride. They also prioritize sustainability and quality control across the manufacturing process.
2. Evonik Industries AG
Company Profile
A leading specialty chemicals manufacturer, Evonik specializes in amino acids for medical and nutritional applications.
Product Range & Capabilities
- Pharma-Grade Arginine Hydrochloride: Evonik offers amino acids compliant with pharmacopoeial standards, including injectable and nutritional grades.
- Manufacturing Footprint: Their global facilities ensure reliable delivery and quality consistency.
- Certifications: cGMP, ISO certifications, and compliance with USP and EP standards.
Market Position
Known for innovation and strict quality control, Evonik appeals to clients requiring high purity, especially in small-volume, high-value pharmaceutical products.
3. Ajinomoto Biopharma Co., Ltd. (Japan)
Company Profile
A dedicated pharmaceutical division of Ajinomoto, focusing exclusively on peptide synthesis, amino acids, and specialty products for injectables.
Product Range & Capabilities
- Pharmaceutical-Grade Arginine Hydrochloride: Suitable for sterile injection solutions and diagnostic uses.
- Manufacturing Standards: Established cGMP-compliant manufacturing lines dedicated to pharmaceutical products.
Market Position
Their specialization in biopharmaceuticals and strict adherence to regulatory standards position them as a preferred supplier for high-demand medical applications.
4. Wuxi AppTec and Other Chinese Manufacturers
Company Profile
Chinese producers like Wuxi AppTec, Anhui Biochem Inc., and others have expanded rapidly in amino acid manufacturing, driven by competitive costs and growing export capacity.
Product Range & Capabilities
- Offer bulk arginine hydrochloride suitable for pharmaceutical and nutritional use.
- Many manufacturers possess ISO and cGMP certifications, but regulatory validation varies.
Market Position
Cost competitiveness and large-scale production capacity dominate their appeal, though buyers should perform rigorous quality audits due to variations in regulatory compliance and standards across manufacturers.
5. Sigma-Aldrich/Merck KGaA
Company Profile
As a global leader in chemical and biological products, Sigma-Aldrich supplies research-grade arginine hydrochloride.
Product Range & Capabilities
- Focused on research and analytical applications.
- Offers high-purity amino acids suitable for laboratory and diagnostic uses.
Market Position
While not primarily a pharmaceutical bulk supplier, their products are relied upon for early-stage research and analytical testing.
Emerging and Niche Suppliers
SinoChem, Huadong Medicine, and other regional manufacturers
These companies are gaining traction with competitive pricing and expanding product offerings, particularly in Asian markets. They often meet basic regulatory standards but require verification for high-end pharmaceutical use.
Supply Chain Considerations
- Quality Assurance: Suppliers must provide GxP compliance, lot-to-lot consistency, and comprehensive Certificates of Analysis.
- Regulatory Certification: Essential for injectable and parenteral applications, including USP, EP, or JP standards, along with cGMP adherence.
- Pricing & Lead Times: Cost competitiveness varies by region, with Asian suppliers typically offering lower prices but necessitating diligent quality audits.
- Logistics & Distribution: Global suppliers leverage sophisticated logistics networks to ensure timely delivery of high-purity compounds.
Conclusion
The pharmaceutical-grade arginine hydrochloride market is dominated by a handful of well-established manufacturers with extensive experience in amino acid production, ensuring quality, regulatory compliance, and supply stability. Ajinomoto and Evonik emerge as the most prominent global suppliers, distinguished by their manufacturing expertise, certifications, and consistent product quality. Chinese and regional manufacturers offer competitive pricing but necessitate diligent oversight to ensure regulatory compliance.
Key Takeaways
- Leading Suppliers: Ajinomoto, Evonik, and Ajinomoto Biopharma are top-tier providers known for quality and regulatory compliance.
- Regulatory Compliance: For injectable and pharmaceutical use, suppliers must demonstrate GMP standards and USP/EP certifications.
- Cost vs. Quality: Asian manufacturers provide cost-effective options but require thorough certification verification.
- Supply Reliability: Long-term partnerships with established suppliers mitigate risks associated with supply disruptions.
- Due Diligence: Rigorous quality audits and certification checks are critical when sourcing from emerging or regional suppliers.
FAQs
1. What are the primary applications of arginine hydrochloride in the pharmaceutical industry?
It serves primarily in parenteral nutrition, diagnostic reagents, and research, facilitating cell growth and metabolic functions in clinical and laboratory settings.
2. How can companies verify the quality of arginine hydrochloride suppliers?
Review certifications such as GMP, USP, EP, and ISO, request detailed Certificates of Analysis, and perform site audits or third-party audits when necessary.
3. Are Chinese suppliers suitable for pharmaceutical-grade arginine hydrochloride?
Many Chinese producers meet international standards and hold certifications; however, verification of regulatory compliance and quality standards is essential to ensure suitability.
4. What are the key considerations when choosing a supplier for high-volume production?
Assess production capacity, supply stability, regulatory compliance, quality certifications, and logistical capabilities.
5. How do pricing dynamics influence sourcing decisions for arginine hydrochloride?
While cost is significant, prioritizing quality and regulatory adherence safeguards against supply disruptions and compliance issues, especially for injectable products.
References
[1] Ajinomoto Co., Inc. corporate website. "Amino Acids." Accessed 2023.
[2] Evonik Industries AG. "Amino Acids for Pharmaceutical Uses." Corporate Brochure, 2022.
[3] Global Amino Acid Market Report, 2022. MarketWatch.
[4] PharmSource. "Amino Acid Supplier Evaluation." 2022.
[5] U.S. Pharmacopeia (USP). "Standards for Amino Acids." 2021.
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