AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	017865	NDA	Baxter Healthcare Corporation	0338-0289-47	3000 mL in 1 BAG (0338-0289-47)	1980-05-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

Aminoacetic acid, commonly known as glycine, is a vital amino acid with diverse therapeutic and industrial applications. The 1.5% formulation in plastic containers often pertains to pharmaceutical or nutritional supplements, intravenous solutions, or laboratory reagents. Securing reliable suppliers for this specific formulation requires a comprehensive understanding of the global manufacturing landscape, quality standards, and compliance with regulatory frameworks. This analysis aims to identify key suppliers, assess market dynamics, and provide strategic insights for procurement professionals seeking aminoacetic acid (glycine) in this particular presentation.

Market Overview of Aminoacetic Acid (Glycine)

Glycine is one of the most abundant amino acids found in collagen and proteins. Its pharmaceutical-grade derivatives are used in neurology, cardiology, and as a dietary supplement. The global demand correlates with expanding healthcare markets and biotechnology development. The compound's stability in plastic containers and compatibility with therapeutic formulations render supply chain reliability critical.

The industry primarily sources glycine from chemical synthesis and fermentation processes, with reputable suppliers adhering to Good Manufacturing Practices (GMP) and regulatory standards like the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional regulators.

Major Suppliers of Aminoacetic Acid 1.5% in Plastic Containers

1. Ajinomoto Co., Inc.

Overview: A leading global producer of amino acids, including glycine, with extensive manufacturing facilities across Asia, Europe, and the Americas.
Product Offerings: High-purity pharmaceutical and food-grade glycine, available in various pack sizes, including small-volume plastic containers suitable for clinical use.
Certifications: GMP, ISO standards, and stringent quality control, ensuring regulatory compliance.
Supply Capabilities: Large-scale production with reliable global distribution networks.

2. CJ CheilJedang

Overview: South Korea-based company with a significant presence in amino acid manufacturing.
Product Offerings: Pharmaceutical-grade glycine in different formulations, including solutions in plastic containers.
Quality Standards: Meets international standards, with adherence to pharmaceutical manufacturing guidelines.
Distribution: Strong Asia-Pacific presence, expanding globally.

3. Wuxi Jinda Pharmaceutical Co., Ltd.

Overview: Chinese manufacturer specializing in amino acids and related pharmaceuticals.
Product Offerings: Glycine solutions suited for clinical and industrial use, supplied in plastic bottles for ease of handling.
Regulatory Compliance: GMP certification, with products exported globally, including North America and Europe.

4. Kyowa Hakko Bio Co., Ltd.

Overview: Japan-based biotechnology firm manufacturing amino acids with a focus on purity and safety.
Product Offerings: Pharmaceutical applications, including glycine solutions in plastic containers.
Certifications: GMP and ISO certification, emphasizing high-quality standards.

5. Yuki Gosei Kogyo Co., Ltd.

Overview: Japanese manufacturer specializing in amino acids with a focus on food and pharmaceuticals.
Product Offerings: Glycine in liquid form in plastic containers, suitable for injectable or oral administration.
Regulatory Standards: Complies with global pharmaceutical manufacturing norms.

Emerging and Niche Suppliers

While the aforementioned are dominant players, several smaller or regional suppliers cater to specific markets:

Shanghai Acebright Pharmaceuticals Co., Ltd.
Zhejiang Nanchang Pharmaceutical Co., Ltd.
Alfa Aesar (Thermo Fisher Scientific) — supplies research-grade glycine, which may be suitable for laboratory use but not clinical applications.

These suppliers often offer competitive pricing but require thorough vetting regarding quality certifications and regulatory compliance.

Key Considerations When Selecting Suppliers

Regulatory Compliance: Verify GMP, FDA, EMA, or regional certifications.
Quality Certifications: Ensure ISO standards and purity specifications are met.
Supply Chain Reliability: Analyze manufacturing capacity, lead times, and distribution networks.
Formulation Compatibility: Confirm that the glycine solution maintains stability in plastic containers.
Pricing and Payment Terms: Negotiate for competitive pricing aligned with quality standards.
Technical Support: Access to comprehensive documentation, stability data, and customer service.

Regulatory and Quality Standards

Procurement of pharmaceutical-grade glycine must align with strict standards:

GMP Compliance: Essential for safety and efficacy in clinical formulations.
Pharmacopoeia Standards: USP, EP, JP, or other regional pharmacopoeias specify purity and testing metrics.
Stability Data: Confirm that glycine solutions in plastic containers retain potency over the intended shelf life.
Container Compatibility: Plastic containers used must be inert, with known standards for leachables and extractables.

Market Trends and Future Outlook

The ongoing expansion of the biotech and pharmaceutical sectors, alongside increasing demand for amino acid-based therapeutics, fuels growth in glycine supply. Suppliers are investing in advanced manufacturing technologies, ensuring higher purity and lower impurity levels. There is a rising trend toward sustainable sourcing and environmentally friendly manufacturing processes, which could influence supplier choice.

The integration of supply chains through digital platforms enhances transparency, traceability, and quality assurance, further benefiting global procurement strategies.

Key Takeaways

Global leaders such as Ajinomoto and Kyowa Hakko dominate the glycine market, with established quality and supply chain reliability.
Regional suppliers in China, South Korea, and Japan offer competitive options, especially for localized sourcing needs.
Regulatory adherence is non-negotiable; all suppliers must meet international GMP and pharmacopoeia standards.
Container compatibility and stability data are critical factors for pharmaceutical applications involving plastic containers.
Long-term partnerships with vetted vendors ensure consistent supply, quality, and regulatory compliance.

FAQs

1. What are the key specifications to verify when sourcing glycine 1.5% in plastic containers?
Ensure the supplier provides Certificate of Analysis (CoA) detailing purity levels, impurity profiles, pH, microbial limits, compatible container types, and stability data confirming shelf life.

2. How does the choice of supplier impact regulatory approval processes?
Suppliers with GMP certification and adherence to pharmacopoeia standards streamline regulatory approvals, reducing delays and compliance risks.

3. Are there cost-effective alternatives to branded suppliers?
Regional manufacturers may offer competitive pricing but require thorough validation of quality and regulatory credentials before selection.

4. What are the main challenges in maintaining glycine solutions in plastic containers?
Potential risks include leaching of plastic components, pH instability, and microbial contamination. Proper packaging, stabilizers, and validated production processes mitigate these issues.

5. How can procurement professionals ensure supply chain resilience?
Diversify supplier base, establish long-term agreements, verify manufacturing capacity, and develop contingency plans to mitigate disruptions.

Conclusion

Sourcing pharmaceutical-grade aminoacetic acid (glycine) at 1.5% concentration in plastic containers demands careful supplier selection centered on quality, regulatory compliance, and supply reliability. Industry giants like Ajinomoto and Kyowa Hakko remain primary options, supported by regional manufacturers in Asia. Staying abreast of technological advancements and industry standards ensures sustained procurement success, critical for pharmaceutical and laboratory applications. Building strategic partnerships with vetted suppliers minimizes risks and supports long-term operational continuity.

References

[1] Ajinomoto Co., Inc. Corporate Website. "Amino acids product portfolio." (2023).
[2] CJ CheilJedang. "Amino acids and derivatives." (2023).
[3] Wuxi Jinda Pharmaceutical Co., Ltd. Official Site. "Glycine solutions." (2023).
[4] Kyowa Hakko Bio Co., Ltd. Product Catalog. "Pharmaceutical amino acids." (2023).
[5] European Pharmacopoeia. "Glycine specifications." (2023).

Suppliers and packagers for AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER