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

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	016784	NDA	B. Braun Medical Inc.	0264-7390-60	4 CONTAINER in 1 CASE (0264-7390-60) / 3000 mL in 1 CONTAINER	2013-12-04
Otsuka Icu Medcl	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	SOLUTION;IRRIGATION	018315	NDA	ICU Medical Inc.	0990-7974-08	4 POUCH in 1 CASE (0990-7974-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG	2019-07-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 14, 2025

Introduction

Glycine, a non-essential amino acid, is extensively used in clinical nutrition, intravenous therapy, and various pharmaceutical formulations. The 1.5% Glycine solution in a plastic container caters primarily to hospitals, clinics, and research laboratories requiring sterile, ready-to-use amino acid solutions. Identifying reliable suppliers for this specific formulation involves discerning manufacturers with proven quality standards, comprehensive GMP compliance, and global distribution capabilities.

Market Overview and Demand Drivers

The pharmaceutical landscape increasingly demands standardized amino acid solutions like Glycine 1.5%, driven by expanding medical tourism, aging populations, and advances in parenteral nutrition protocols. Hospitals and pharmaceutical companies seek suppliers offering high purity, stability, and consistent supply, particularly in ready-to-use plastic containers that facilitate ease of administration and storage.

Key Attributes Sought in Suppliers

Regulatory Compliance: Suppliers should possess certifications such as GMP, ISO 9001, and adherence to pharmacopeia standards (USP, EP, BP).
Product Quality & Purity: High analytical purity, sterile filtration, endotoxin levels within permissible limits.
Packaging Capabilities: Expertise in sterilized, pharmaceutical-grade plastic containers—preferably polypropylene or polyethylene—designated for parenteral administration.
Global Reach & Supply Continuity: Capacity to fulfill large-volume orders across regions, ensuring minimal stockouts.
Traceability & Documentation: Robust documentation, batch traceability, and quality assurance processes.

Global Suppliers of Glycine 1.5% in Plastic Containers

1. Ajinomoto Co., Inc.

Overview: A leading global manufacturer of amino acids, including glycine, with facilities certified under GMP and ISO standards.
Product Attributes: Offers pharmaceutical-grade glycine solutions in various formulations, including sterile, ready-to-use solutions in plastic containers.
Distribution: Extensive global logistics network, serving hospitals and pharma companies across North America, Europe, and Asia.
Quality Assurance: Maintains strict quality controls compliant with US Pharmacopeia (USP) and European Pharmacopoeia (EP).

2. Fuji Drug Co., Ltd.

Overview: A Japanese pharmaceutical firm specializing in amino acids and nutritional solutions.
Product Offerings: Provides sterile Glycine solutions in plastic containers suitable for IV administration.
Regulatory Standards: GMP-certified manufacturing with international quality accreditations.
Distribution: Supplies predominantly across Asia, with expanding presence in Europe and North America.

3. CJ CheilJedang Corporation

Overview: A South Korean multinational that produces amino acids and pharmaceuticals.
Product Range: Offers sterile solutions including Glycine in various concentrations and packaging formats.
Quality Systems: Complies with Good Manufacturing Practices and offers products with validated purity levels.
Supply Chain: Capable of large batch production and global distribution.

4. Merck KGaA (EMD Serono)

Overview: A global leader in biopharmaceuticals with a portfolio that includes amino acid-based products.
Product Profile: Provides pharmaceutical-grade amino acids, with specific formulations in plastic containers for clinical use.
Certifications: GMP, ISO, and regulatory approvals across multiple regions.
Distribution Strategy: Focused on hospitals, research institutions, and pharmaceutical companies worldwide.

5. Mylan / Viatris (Now part of Viatris Inc.)

Overview: Known for producing sterile solutions and amino acids for parenteral nutrition.
Product Line: Supplies Glycine 1.5% solutions in sterile plastic containers suitable for IV infusion.
Quality Standards: Compliance with FDA, EMA, and other international standards.
Supply Capabilities: Large-scale manufacturing ensuring consistent availability.

Specialist and Regional Suppliers

While global giants dominate, regional pharmaceutical ingredient suppliers also serve local markets. Examples include:

Hubei Huitian Biological Technology Co., Ltd. (China): Produces amino acids including Glycine, often supplying bulk raw materials which can be formulated into sterile solutions locally.
Glanbia Nutritionals (Ireland): Offers amino acids in bulk, with certain formulations suitable for pharmaceutical standards.

Points to Consider When Choosing Suppliers

Verify Certification and Regulatory Compliance: Ensure suppliers meet specific regional pharmaceutical standards.
Assess Quality Documentation: Request COAs, sterilization validation reports, endotoxin testing, and stability data.
Evaluate Packaging and Sterility Methods: Confirm suitable plastic container materials and sterilization processes.
Check Supply Chain Reliability: Evaluate the supplier’s ability to meet demand consistently.
Conduct Technical Validation: Confirm product stability and compatibility in your application through testing and validation.

Regulatory and Quality Considerations

Procurement of Glycine solutions should align with regulatory requirements pertinent to the target market, whether FDA (USA), EMA (Europe), or other regulatory bodies. Suppliers with active product registration or approval in these jurisdictions streamline compliance and reduce market entry hurdles.

Emerging Trends and Future Outlook

The pharmaceutical industry is shifting toward more personalized parenteral nutrition solutions, with suppliers investing in rapid formulation and packaging customization. The increasing demand for sterile, single-use containers aligns with innovations in plastic container design, sterility assurance, and supply chain digitization. Suppliers integrating digital documentation, blockchain traceability, and advanced sterilization techniques are gaining a competitive edge.

Key Takeaways

Leading international suppliers such as Ajinomoto, Fuji Drug, CJ CheilJedang, Merck KGaA, and Viatris dominate the Glycine 1.5% in plastic container market.
Quality assurance, strict GMP compliance, and reliable global logistics underpin supplier selection.
Regional suppliers can be viable for localized markets but require thorough validation of quality standards.
Ensuring regulatory compliance and comprehensive documentation accelerates market deployment.
Continuous innovation in packaging and supply chain transparency enhances supplier value propositions.

FAQs

1. What certifications should I verify before sourcing Glycine 1.5% solutions?
Verify GMP certification, ISO standards, pharmacopeia compliance (USP, EP, BP), and regional regulatory approvals to ensure product quality and compliance.

2. Are Glycine solutions available in pre-sterilized plastic containers?
Yes, major suppliers provide sterile, ready-to-use Glycine solutions in pre-sterilized plastic containers suitable for intravenous use.

3. How do I evaluate the quality of Glycine solutions from different suppliers?
Request Certificates of Analysis, endotoxin and microbial testing reports, stability data, and documentation of sterilization and manufacturing processes.

4. Can regional suppliers meet the same standards as global companies?
Many regional suppliers are GMP-certified and export products adhering to international standards. Due diligence is essential to confirm certifications and quality control systems.

5. What are the common packaging materials for Glycine 1.5% in pharmaceutical applications?
Polypropylene and polyethylene are commonly used plastics for sterile, pharmaceutical-grade containers due to their inertness and compatibility with intravenous solutions.

References

Ajinomoto Co., Inc. – Corporate website [1]
Fuji Drug Co., Ltd. – Product catalogs and GMP certifications [2]
CJ CheilJedang – Amino acids product specifications [3]
Merck KGaA – Pharmaceutical solutions portfolio [4]
Viatris Inc. – Supply chain and product documentation [5]

Note: The above details are based on publicly available industry data, product catalogs, and manufacturer disclosures as of 2023. For precise procurement, direct engagement with suppliers and validation of certifications are recommended.

Suppliers and packagers for GLYCINE 1.5% IN PLASTIC CONTAINER