Bulk Pharmaceutical API Sources for AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		sJX`BDdvu@@
Specs		AB-131/40217813
Sigma-Aldrich		410225_SIAL
Sigma-Aldrich		G5417_SIGMA
Sigma-Aldrich		G7126_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: Aminoacetic Acid 1.5% in Plastic Container

Last updated: August 5, 2025

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Introduction

Aminoacetic acid, commonly known as glycine, is a fundamental amino acid utilized across pharmaceutical, cosmetic, and industrial sectors. Its applications include formulations for injectables, topical solutions, and manufacturing intermediates. The demand for high-grade aminoacetic acid in liquid formulations, especially at a 1.5% concentration packaged in plastic containers, necessitates sourcing from reliable API manufacturers with consistent quality and regulatory compliance. This report provides a comprehensive assessment of global API suppliers capable of providing aminoacetic acid suitable for pharmaceutical applications, focusing on bulk supply channels, quality standards, and market positioning.

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Overview of Aminoacetic Acid (Glycine) in Pharmaceutical Industry

Glycine serves as a non-essential amino acid with roles in protein synthesis, neurotransmitter modulation, and as an excipient in pharmaceutical formulations. When used at a 1.5% concentration in liquid preparations, stability, purity, and compatibility with packaging materials are paramount. The API suppliers must adhere to stringent regulatory standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and the World Health Organization (WHO) guidelines to ensure safety, efficacy, and regulatory acceptance.

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Global API Suppliers for Aminoacetic Acid

1. Merck KGaA (Sigma-Aldrich International)

Overview: Merck, through its Sigma-Aldrich brand, is a leading global supplier of high-purity amino acids, including glycine. They offer pharmaceutical-grade APIs with comprehensive documentation, certifications, and supply chain reliability.

• Quality Standards: USP, EP, FCC, ICH Q7
• Production Capabilities: Large-scale manufacturing with controlled processes compliant with cGMP
• Packaging Options: Bulk quantities suitable for filling into plastic containers; options include sterile and non-sterile forms
• Certifications: Valid ISO, GMP, and regulatory approvals across key markets

Market positioning: Merck’s reputation for rigorous quality control and extensive distribution network makes it a preferred choice for pharmaceutical manufacturers seeking reliable supply of aminoacetic acid.

2. Evonik Industries

Overview: Evonik is a prominent specialty chemicals company producing pharmaceutical-grade amino acids, including glycine, with a focus on APIs for injection, infusion, and topical formulations.

• Quality Standards: Analyzed under USP, EP, and other pharmacopeias, with compliance to cGMP standards
• Supply Flexibility: Capable of delivering bulk API suitable for easy transfer into plastic bottles
• Technical Support: Offers technical data, stability reports, and regulatory documentation to facilitate formulation development

Market positioning: Evonik’s reputation in biochemicals and APIs positions it as a secure vendor for pharmaceutical-grade aminoacetic acid, particularly for liquid preparations.

3. Shanghai Jiuzhou Pharmaceutical Co., Ltd. (China)

Overview: A major Chinese API manufacturer with extensive experience in producing amino acids for pharmaceutical use, including glycine.

• Quality Standards: Meets Chinese Pharmacopoeia (ChP), with certifications for overseas markets including USP and EP upon request
• Production Scale: Large, with capacity to supply bulk quantities suitable for liquid formulation projects
• Regulatory Readiness: Provides documentation for regulatory submissions in multiple jurisdictions

Market positioning: Cost-competitive with a growing presence in Asian and emerging markets; suitable for companies seeking cost-effective sourcing options with validated quality.

4. Wockhardt Ltd.

Overview: An Indian pharmaceutical and biotech firm manufacturing amino acids, including glycine, with global exports.

• Quality Compliance: GMP-certified, ensuring API suitable for injectable and oral pharmaceutical products
• Supply Capabilities: Bulk API production in compliance with international standards; scalable for ongoing supply
• Packaging: Options include HDPE drums and containers compatible with plastic packaging requirements

Market positioning: Wockhardt excels in delivering affordable, high-quality aminoacetic acid for formulation needs across emerging markets.

5. Hubei New Donga Pharmaceutical Co., Ltd.

Overview: A Chinese API manufacturer specializing in amino acids for pharmaceutical use, including glycine, with exports targeted globally.

• Quality Assurance: Meets Chinese pharmacopeia standards, with additional certifications for international markets
• Capacity: Capable of supplying large quantities suitable for pharmaceutical use, with custom packaging options
• Price Point: Competitive, especially for high-volume orders

Market positioning: Suitable for cost-sensitive projects, with reliable quality assurance aligned with global standards.

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Key Considerations for API Sourcing

• Regulatory Compliance: Confirm supplier adherence to pharmacopeial standards (USP, EP) and cGMP to ensure regulatory acceptance.
• Quality Certifications: Seek suppliers with ISO, GMP, and batch certification records.
• Supply Chain Reliability: Prioritize vendors with established logistics capabilities, MOQ flexibility, and long-term supply stability.
• Documentation and Support: Ensure availability of technical data sheets, stability reports, and regulatory dossiers.
• Packaging Compatibility: Verify vendor capability to supply aminoacetic acid in formulations compatible with plastic containers, including stability in HDPE or LDPE bottles.

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Market Trends and Directions

The global demand for aminoacetic acid in pharmaceutical and supplement industries continues to rise, driven by a growing need for safe, affordable, and high-purity APIs. Manufacturers are increasingly focusing on sourcing from countries with mature regulatory frameworks, such as the US, Europe, and Japan, although emerging markets like China and India remain critical due to cost advantages.

The trend towards consolidation among chemical suppliers enhances quality assurance and supply chain security. Additionally, increasing demand for liquid formulations necessitates supplier proficiency in API production suitable for stable suspension or solution forms in plastic packaging.

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Conclusion

The selection of a bulk aminoacetic acid supplier for pharmaceutical applications—particularly at a 1.5% concentration in plastic containers—requires rigorous evaluation of quality standards, regulatory compliance, manufacturing capacity, and supply chain robustness. Leading global suppliers like Merck KGaA and Evonik Industries maintain their leadership positions owing to their consistent quality and regulatory credibility. Chinese manufacturers such as Shanghai Jiuzhou Pharmaceutical and Hubei New Donga offer cost-effective alternatives with expanding compliance frameworks.

For pharmaceutical companies, strategic partnerships with recognized, compliant suppliers can ensure the consistent, high-quality supply necessary for safe and effective formulations.

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Key Takeaways

• Prioritize suppliers with relevant pharmacopeial certifications (USP, EP, ChP) and adherence to cGMP.
• Evaluate supply chain reliability, especially for large-volume, long-term projects.
• Confirm packaging options are compatible with plastic containers and do not compromise API stability.
• Consider regional suppliers to optimize costs, but verify their compliance for international approval.
• Maintain comprehensive documentation, including stability data and regulatory dossiers, for seamless regulatory approval processes.

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FAQs

1. What quality standards should I require from my aminoacetic acid API supplier?
Suppliers should meet pharmacopeial standards such as USP, EP, or ChP and possess GMP certification to guarantee purity, safety, and regulatory compliance.

2. Can aminoacetic acid sourced from China meet international pharmaceutical standards?
Yes, many Chinese manufacturers produce glycine that complies with international standards, especially if they possess relevant certifications and quality documentation. Due diligence is essential.

3. Is pharmaceutical-grade aminoacetic acid suitable for liquid formulations in plastic containers?
Absolutely. Pharmaceutical-grade APIs are formulated for stability in liquid forms, and suppliers typically provide appropriate packaging options like HDPE bottles that do not interact adversely with the API.

4. What are the typical lead times for bulk aminoacetic acid orders?
Lead times generally range from 4 to 12 weeks, depending on the supplier, quantity, and regulatory clearance processes.

5. How can I evaluate the stability of aminoacetic acid in plastic containers?
Request stability data from suppliers, conduct stability testing under relevant storage conditions, and select packaging materials compatible with the API to maintain its integrity over the intended shelf life.

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Sources:
[1] Sigma-Aldrich. (2023). Glycine (Aminoacetic Acid) Specification and Product Data.
[2] Evonik Industries. (2023). Pharmaceutical Amino Acid Portfolio.
[3] Shanghai Jiuzhou Pharmaceutical Co., Ltd. Official Website.
[4] Wockhardt Ltd. Corporate Reports.
[5] Hubei New Donga Pharmaceutical Co., Ltd. Product Catalog.