Suppliers and packagers for generic pharmaceutical drug: ARGININE HYDROCHLORIDE

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

Suppliers for Arg나는ine Hydrochloride

Last updated: February 20, 2026

Who are the primary suppliers of arginine hydrochloride?

Arginine hydrochloride is a widely used amino acid supplement with applications in pharmaceutical, nutritional, and research markets. Major suppliers include specialty chemical manufacturers, pharmaceutical ingredient companies, and bulk API producers.

Leading Suppliers Overview

Supplier	Headquarters	Production Capacity	Key Markets Served	Certification Status	Notes
Ajinomoto Co. Inc.	Japan	Several hundred tons/year	Global, especially Asia and North America	GMP, ISO 9001, ISO 22000	Large-scale producer; recognized for high purity APIs
Evonik Industries	Germany	Over 50,000 tons/year	North America, Europe, Asia	GMP, ISO 9001	Diversified amino acid portfolio
Sichuan Blue Sword Pharmaceutical	China	10,000+ tons/year	Asia, emerging markets	GMP, ISO 9001	Major Chinese API supplier, competitive pricing
Glentham Life Sciences	UK	Several thousand kg/week	Europe, North America	GMP, ISO 9001, Kosher	Focus on research and pharmaceutical grade
Shanghai Fosun Pharmaceutical	China	Multiple tons/year	China, Asia	GMP	Integrated pharmaceutical company, broad API portfolio

Source and Production Details

• Ajinomoto, one of the most prominent amino acid producers globally, produces arginine hydrochloride primarily from microbial fermentation processes. It holds multiple patents related to production methods and purity standards.
• Evonik Industries utilizes synthetic routes with proprietary purification techniques, focusing on high-quality pharmaceutical grade APIs.
• Chinese manufacturers like Sichuan Blue Sword leverage fermentation with optimized strains and low-cost sourcing, increasing supply margins for Asian markets.

Quality and Certification Standards

Suppliers mainly adhere to recognized standards:

• Good Manufacturing Practices (GMP) for pharmaceutical-grade APIs
• International Organization for Standardization (ISO) certifications (ISO 9001 for quality management, ISO 22000 for food safety)
• Kosher and Halal certifications for regional compliance

Supply Chain Considerations

• Capacity fluctuations due to environmental or regulatory factors can influence supply stability.
• Suppliers with integrated downstream processing capabilities tend to maintain higher control over purity and quality.
• Lead times for new supply agreements typically range from 3 to 6 months, depending on certification requirements.

Market Trends and Competitive Dynamics

• Growing demand for arginine hydrochloride in nutraceuticals, driven by increased awareness of amino acids in wellness products.
• Expansion of pharmaceutical manufacturing in Asia has increased regional supply capacity.
• Price sensitivity remains high; Chinese manufacturers offer the most competitive pricing due to lower production costs.
• Suppliers are investing in fermentation technology to improve yield and reduce reliance on synthetic routes.

Summary of Key Suppliers for Argˀinine Hydrochloride

Supplier Name	Primary Market Focus	Production Method	Certifications	Estimated Capacity (tons/year)
Ajinomoto Co. Inc.	Global, pharmaceutical, nutraceuticals	Microbial fermentation	GMP, ISO 9001, ISO 22000	300-500
Evonik Industries	Global, pharmaceutical and food	Synthetic/high purity	GMP, ISO 9001	50,000+
Sichuan Blue Sword Phama	China, Asia	Fermentation	GMP, ISO 9001	10,000+
Glentham Life Sciences	Europe, North America	Fermentation, synthesis	GMP, ISO 9001, Kosher	Several thousand kg/week
Shanghai Fosun Pharma	China, Asia	Fermentation, synthesis	GMP	Multiple tons/year

Final Notes

• The market is dominated by Asian producers, with Western companies primarily serving niche markets requiring high standards or specific certifications.
• Suppliers with established GMP and high purity certifications are preferred for pharmaceutical applications.
• Price negotiations depend heavily on volume, certification needs, and delivery timelines.

Key Takeaways

• Ajinomoto, Evonik, and Sichuan Blue Sword form the core supply chain.
• Capacity and certification are critical factors for pharmaceutical-grade procurement.
• Chinese suppliers dominate in cost competitiveness and volume capacity.
• Supply stability can be impacted by regulatory and environmental factors.

FAQs

1. What are the main applications of arginine hydrochloride?
It is used in dietary supplements, parenteral nutrition, and as an ingredient in medications for cardiovascular health and immune support.

2. How do manufacturing methods differ among suppliers?
Ajinomoto predominantly uses microbial fermentation; others may use synthetic chemical routes or combined approaches.

3. Are there regional differences in supplier quality standards?
Yes; Western suppliers tend to strictly adhere to GMP, ISO, and pharmacopeial standards, while some Chinese producers may have varying certifications depending on target markets.

4. What are typical lead times for securing arginine hydrochloride from suppliers?
From 3 to 6 months, depending on the certification, order volume, and current capacity.

5. How does market demand influence supply?
Rising demand for amino acids in health products and pharmaceuticals increases competition and price pressures, especially in Asian markets.

Sources

[1] PharmSource. "Arginine Hydrochloride Market Overview," 2022.

[2] Ajinomoto Co., Annual Report, 2022.

[3] Evonik Industries. "Amino Acid Production Capabilities," 2023.

[4] Global Industry Analysts, "Amino Acids - Market Analysis," 2023.

[5] Chinese API Manufacturers Directory, 2023.