Suppliers and packagers for generic pharmaceutical drug: glycine

glycine

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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
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

Suppliers for the Pharmaceutical Drug: Glycine

Last updated: July 28, 2025

Introduction

Glycine, a simple non-essential amino acid, plays vital roles in protein synthesis, neurotransmission, and metabolic pathways. Its medical and pharmaceutical applications span from dietary supplements to potential therapeutic agents, necessitating a reliable, compliant supply chain. This article examines key suppliers for pharmaceutical-grade glycine, considering manufacturing sources, geographic diversity, quality standards, and regulatory compliance imperative for global pharmaceutical markets.

Overview of Glycine in Pharmaceuticals

Glycine's medical applications rely heavily on its pharmaceutical-grade purity, typically requiring standards such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). Its forms include crystalline powder, solutions, and derivatives used as excipients or active pharmaceutical ingredients (APIs). Ensuring supply chain robustness necessitates understanding the major suppliers adhering to good manufacturing practices (GMP) and regulatory compliance.

Global Core Suppliers of Pharmaceutical-Grade Glycine

1. China

China is the dominant global manufacturer of amino acids, including glycine, owing to its large-scale production capacity and cost competitiveness.

• Shandong Uonly Bio Pharma Co., Ltd. – A leading producer specializing in amino acids, including pharmaceutical-grade glycine. The company complies with GMP standards and exports globally, supplying large volumes for pharmaceutical and nutrition industries.

• Shangdong Lianhua Bio-Tech Co., Ltd. – Known for high-quality amino acid production, including precision purification of glycine for medical applications.

• Jiangsu Suyash Pharmaceutical Co., Ltd. – Manufactures pharmaceutical-grade amino acids, with certifications including ISO9001 and GMP, targeting both domestic and international markets.

2. India

India's pharmaceutical industry has expanded its amino acid production, complying with WHO-GMP standards, with significant domestic demand and export footprint.

• Suyash Chemicals & Pharmaceuticals Pvt. Ltd. – Offers pharmaceutical-grade glycine, adhering to stringent quality standards suitable for European and American markets.

• GlycoAmino Pvt. Ltd. – Focuses on amino acids for parenteral and enteral nutrition, highlighting high purity grades.

3. European Producers

Europe emphasizes regulatory compliance and quality assurance, with some specialized suppliers.

• Evonik Industries AG (Germany) – Although primarily known for amino acids like L-glutamine and L-lysine, Evonik provides high-grade amino acids, including glycine suitable for pharmaceutical use, with extensive GMP compliance.

• Meihua Holdings International Ltd. (China-based but with European distribution networks) – Supplies pharmaceutical-grade amino acids adhering to international standards, including glycine.

4. North American Suppliers

North American sources are fewer but notable for high regulatory standards.

• Meryx Pharma Inc. (Canada) – Specializes in GMP-certified amino acids, including glycine, for pharmaceutical applications.

• Roquette Frères (France, with North American operations) – Provides pharmaceutical excipients and amino acids complying with sophisticated regulatory standards, including glycine.

Quality and Regulatory Standards

Suppliers must adhere to global pharmacopoeia standards:

• GMP Certification: Ensures consistent, high-quality production suitable for injectable and oral medicines.
• ISO Certifications: Demonstrate rigorous quality management (ISO 9001, ISO 22000).
• Regulatory Approvals: FDA, EMA, and other agencies' approvals are critical for suppliers targeting markets with strict compliance demands.

Supply Chain Considerations

• Purity and Compliance: Pharmaceutical glycine typically necessitates purity levels exceeding 98%, with minimal contaminants like heavy metals, residual solvents, or microbial impurities.
• Traceability and Documentation: Suppliers with proven traceability and comprehensive batch documentation dominate the pharmaceutical supply chain.
• Capacity and Lead Times: Large-scale producers offer more reliable delivery, critical for continuous manufacturing (CM).

Challenges in sourcing pharmaceutical glycine

• Regulatory Variability: Different markets have unique requirements—suppliers should possess certifications aligned with target regions.
• Price Volatility: Raw material costs and geopolitical factors influence pricing, affecting supply stability.
• Quality Assurance: Ongoing validation and rigorous testing are non-negotiable for pharmaceutical use, reducing dependency on suppliers lacking transparency.

Emerging Suppliers and Innovations

Innovations in biotechnological manufacturing, including microbial fermentation processes, are emerging as alternative methods to chemical synthesis, potentially offering higher purity and sustainable production.

• Biotech firms specializing in amino acid biosynthesis—such as Ajinomoto—are advancing their capabilities to supply pharmaceutical-grade glycine using fermentation technology, reducing reliance on chemical synthesis.

Conclusion

The pharmaceutical supply chain for glycine is predominantly anchored by Chinese producers with vast manufacturing bases, complemented by European, Indian, and North American suppliers who emphasize regulatory compliance and high purity standards. Pharmaceutical companies seeking reliable supply should prioritize manufacturers with proven GMP certifications, comprehensive quality assurance systems, and adherence to international regulatory standards.

Key Takeaways

• China leads globally in glycine production, offering cost-effective bulk supply, but strict compliance checks are essential.
• European and North American suppliers emphasize regulatory adherence, offering high-purity pharmaceutical-grade glycine suitable for stringent markets.
• Emerging biotechnological methods hold promise for higher purity and sustainable supply, diversifying sources.
• Ensuring full traceability, GMP compliance, and robust documentation underpins supply reliability for pharmaceutical applications.
• Monitoring geopolitical and market dynamics is critical for logistics and pricing stability, especially amid shifting trade policies.

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FAQs

1. What are the primary regulatory standards for pharmaceutical-grade glycine suppliers?
Suppliers must comply with pharmacopoeial standards such as USP, EP, or JP, and possess GMP certifications from authorities like the FDA or EMA, ensuring product safety, purity, and consistent quality.

2. How do I assess the quality of glycine suppliers?
Evaluate their certifications, batch testing reports, traceability protocols, production capacity, and reputation within the industry. Verifying independent quality audits and certifications like ISO 9001 is also crucial.

3. Is biotechnological synthesis a viable alternative for pharmaceutical glycine production?
Yes. Microbial fermentation offers a sustainable approach with potential for higher purity. Companies investing in biotech processes are expected to meet or exceed current purity standards and regulatory requirements.

4. Are there regional differences in sourcing pharmaceutical glycine?
Yes. Chinese suppliers dominate due to scale and cost, but European and North American providers often focus on higher regulatory compliance and stricter quality standards, vital for markets with rigorous approval processes.

5. How does supply chain stability influence pharmaceutical glycine procurement?
A reliable supply chain ensures uninterrupted drug manufacturing, compliance, and quality assurance. Diversifying suppliers and maintaining strategic inventories are practices to mitigate risks associated with geopolitical shifts and market fluctuations.

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Sources
[1] U.S. Pharmacopeia (USP) standards for amino acids.
[2] European Pharmacopoeia (EP) monographs on amino acids.
[3] Industry reports on amino acid manufacturing and trade statistics.
[4] Company disclosures from Evonik, Ajinomoto, and others regarding manufacturing capacities and certifications.
[5] Market insights from Global Industry Analysts, amino acid supply chain analyses.