Bulk Pharmaceutical API Sources for GLYCINE 1.5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for GLYCINE 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

Bulk Active Pharmaceutical Ingredient (API) Sources for: GLYCINE 1.5% IN PLASTIC CONTAINER

Last updated: August 13, 2025

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Introduction

Glycine, an amino acid with therapeutic and cosmetic applications, is increasingly produced in bulk for formulation into various products, including ophthalmic solutions, skin creams, and infusion therapies. Specifically, a 1.5% Glycine solution formulated in plastic containers presents unique sourcing and manufacturing considerations. This article provides a comprehensive overview of reliable API sources for Glycine at this concentration, focusing on producers specializing in pharmaceutical-grade amino acids, international supply chains, quality assurance, and regulatory compliance.

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Understanding Glycine as an API

Glycine (C₂H₅NO₂) is classified as a non-essential amino acid, vital for protein synthesis, neurotransmission, and clinical applications such as neuroprotection, metabolic support, and as an excipient. Pharmaceutical-grade Glycine must meet stringent standards like USP, EP, or FCC compliance to ensure safety and efficacy in medical formulations.

Given its use in medical and cosmetic formulations, sourcing high-purity Glycine API with consistent quality, stability, and supply chain reliability is paramount. The focus here is on suppliers capable of providing bulk quantities suitable for formulation into 1.5% Glycine solutions in plastic containers—typically polypropylene bottles, owing to their chemical inertness and safety profile.

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1. Leading Global API Suppliers for Glycine

1.1. Ajinomoto Co., Inc.

Overview:
Ajinomoto stands as a prominent producer of amino acids, including pharmaceutical-grade Glycine, with operations spanning Japan, the United States, and Europe. Known for rigorous quality standards, Ajinomoto supplies Glycine APIs that comply with pharmacopoeial requirements (USP, EP).

Capabilities and Quality:

• Offer Glycine in various grades, including pharmaceutical, food, and technical.
• Consistent supply chain and large-scale manufacturing capacity.
• Strict adherence to cGMP standards to ensure batch-to-batch consistency.

Applications:
Suitable for pharmaceutical formulations requiring high purity Glycine, such as infusion solutions, oral medications, and topical formulations.

Regulatory Compliance:
Typically possess ISO, GMP, and pharmacopoeial certifications, facilitating global distribution and regulatory approval.

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1.2. Beijing Shuangliu Biotech Co., Ltd.

Overview:
A leading Chinese supplier specializing in amino acids for pharmaceutical and nutraceutical markets, Shuangliu Biotech offers USP, EP, and JP grade Glycine.

Capabilities and Quality:

• Focuses on pharmaceutical-grade API production with comprehensive testing.
• Large inventory and ability to supply large orders efficiently.
• Emphasizes quality assurance via advanced analytical testing (HPLC, residual solvents, heavy metals, microbial limits).

Applications:
Ideal for producers seeking cost-effective, high-quality Glycine API suitable for injectable and topical preparations.

Regulatory Status:
Registered with Chinese FDA and compliant with international standards; some products are exported globally.

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1.3. Evonik Industries

Overview:
Evonik is a global specialty chemicals company, with a significant portfolio of amino acids including Glycine, produced via fermentation processes.

Capabilities and Quality:

• Premium quality, pharmaceutical grade Glycine, with high purity levels (≥99%).
• Extensive capacity for bulk supply, including APIs suitable for parenteral use.
• Certified under GMP, ISO, and other international quality standards.

Applications:
Provides Glycine APIs suitable for infusion solutions, injection, and cosmetic formulations.

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1.4. World Precision Instruments (WPI)

Overview:
Although primarily known for research-grade amino acids, WPI's pharmaceutical-grade Glycine is available in bulk for laboratory and small production requirements.

Capabilities and Quality:

• Meets pharmacopeial specifications, with available certificates of analysis.
• Suitable for small to medium-scale production.

Limitations:
Primarily research use; suitable for pilot projects or formulations in development stages.

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1.5. DSM Nutritional Products

Overview:
DSM offers amino acids including Glycine for pharmaceutical and dietary supplement applications.

Capabilities and Quality:

• Produces high-purity Glycine API, conforming to USP and EP standards.
• Capacity for large-scale supply with reliable logistics.

Applications:
API suitable for infusion, oral, and topical pharmaceuticals.

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2. Regional and Specialty API Suppliers

2.1. Shandong Yuwang Pharmaceutical Co., Ltd.

A Chinese manufacturer offering pharmaceutical-grade amino acids, including Glycine, with competitive pricing and compliance with international standards.

2.2. Vitas Amix Pvt. Ltd.

An Indian supplier providing GMP-certified Glycine APIs with export capabilities to global markets.

2.3. Evonik’s subsidiaries in Asia and Europe

Offering localized production and distribution of high-grade Glycine APIs.

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3. Considerations for Selection of API Suppliers

Quality Assurance:
Certifications such as USP, EP, KOSHER, HALAL, and ISO 9001 are essential to ensure regulatory compliance and product safety.

Documentation & Testing:
Suppliers should provide comprehensive Certificates of Analysis (CoA), stability data, and detailed analytical reports to verify purity, moisture content, residual solvents, and microbial limits.

Supply Chain Reliability:
Manufacturers with established logistics, warehousing, and backup suppliers minimize risks related to shortages or delays.

Cost & Lead Times:
Market competitiveness varies; establishing long-term relationships can ensure consistent pricing and delivery schedules.

Regulatory Support:
Suppliers with experience in exporting to target markets—e.g., US, EU, Japan—facilitate regulatory approval of the final product formulations.

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4. Regulatory and Compliance Landscape

Manufacturers and formulators must verify that Glycine APIs meet pharmacopoeial standards or equivalent specifications applicable to their markets. Proper documentation, stability data, and adherence to Good Manufacturing Practices (GMP) are vital for regulatory approval of medical or cosmetic products containing Glycine in plastic containers.

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5. Customization and Packaging

Most suppliers offer API in bulk powder form, which can be formulated in sterile or non-sterile conditions depending on the application. For solutions in plastic containers, APIs will need to be compatible with filling processes, with considerations for excipient interactions, stability, and preservative compatibility.

Special considerations include ensuring that the Glycine API does not introduce leachables or extractables from packaging materials, and that it maintains stability over the product’s shelf life in plastic containers.

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Key Takeaways

• Leading global suppliers such as Ajinomoto, Evonik, and DSM provide high-quality, pharmaceutical-grade Glycine APIs suitable for formulation into 1.5% solutions in plastic containers.

• Chinese manufacturers like Beijing Shuangliu Biotech, along with Indian suppliers such as Vitas Amix, offer cost-effective options with competitive lead times.

• Strict adherence to regulatory standards, comprehensive testing, and certification underpin supplier reliability in pharmaceutical applications.

• Collaboration with reputed suppliers reduces risks related to quality, regulatory approval, and supply chain disruptions.

• Proper packaging compatibility testing ensures API stability and safety in plastic container products.

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FAQs

Q1: What quality certifications should I look for in Glycine API suppliers?
A: Look for suppliers with USP, EP, or FCC certifications, along with ISO 9001, GMP compliance, and detailed Certificates of Analysis.

Q2: Is pharmaceutical-grade Glycine suitable for cosmetic formulations?
A: Yes. Pharmaceutical-grade Glycine’s high purity and compliance with safety standards make it suitable for cosmetic and topical applications.

Q3: What factors influence the cost of Glycine API?
A: Quantity ordered, grade specifications, supplier location, certification standards, and logistical costs primarily influence pricing.

Q4: Can Glycine API be supplied in sterile conditions for infusion use?
A: Yes. Some suppliers offer sterile and pyrogen-free Glycine APIs suitable for injectable formulations.

Q5: What are the stability considerations for Glycine in plastic containers?
A: Glycine is chemically stable in aqueous solutions with proper pH control; compatibility with container plastics is well established, but stability testing is recommended for specific formulations.

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References

1. [1] Ajinomoto Co., Inc. Pharmaceutical amino acids product catalog.
2. [2] Beijing Shuangliu Biotech Co., Ltd. API datasheets and certifications.
3. [3] Evonik Industries. Amino acids technical data sheets.
4. [4] Vitas Amix Pvt. Ltd. Product listings and specifications.
5. [5] USP Monograph for Glycine, USP-NF, 2023 Edition.