Bulk Pharmaceutical API Sources for glycine

Bulk Pharmaceutical API Sources for glycine

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		sJX`BDdvu@@
Specs		AB-131/40217813
Sigma-Aldrich		410225_SIAL
Sigma-Aldrich		G7126_SIGMA
Sigma-Aldrich		G7403_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: Glycine

Last updated: July 27, 2025

Introduction
Glycine, a non-essential amino acid, plays a vital role in several physiological processes, including protein synthesis, neurotransmission, and metabolic pathways. Owing to its diverse applications—from dietary supplements and pharmaceuticals to cosmetics—the demand for high-quality glycine API has grown significantly. Ensuring a reliable and compliant supply chain involves understanding the landscape of bulk glycine API sources, including leading manufacturers, regional production hubs, and quality standards applicable across the industry.

Global Manufacturing Landscape of Glycine API
The production of glycine API is concentrated predominantly in Asia, particularly China and India, which dominate the global supply chain owing to their robust chemical manufacturing infrastructure, cost advantages, and large-scale facilities. European and North American producers contribute to a smaller, but strictly regulated segment emphasizing high purity and compliance with pharmacopeial standards.

Leading Manufacturers of Glycine API

1. China-Based Manufacturers
China is the preeminent producer of glycine API, accounting for an estimated 70-80% of global output, according to industry reports from Research and Markets and Grand View Research. Major Chinese firms include:

• Jiangsu Hengshui Interchemical Co., Ltd.
  Known for its extensive portfolio of amino acids and specialty chemicals, this company supplies bulk glycine APIs to global markets, particularly for bulk pharmaceutical and feed applications.

• Shanxi Guoxin Group Co., Ltd.
  A large-scale producer offering pharmaceutical-grade glycine API with competitive pricing and adherence to Chinese Good Manufacturing Practices (GMP).

• Zhejiang Honghua Pharmaceutical Co., Ltd.
  Focused on amino acids, this company supplies both pharmaceutical and feed-grade glycine with a focus on quality control.

2. Indian Manufacturers
India’s amino acid manufacturing sector is also significant, driven by the pharmaceutical and nutraceutical sectors:

• Venkys India Ltd.
  Supplies pharmaceutical-grade glycine API with approvals aligned with Indian pharmacopeial standards (IP) and international requirements.

• Dharma Impex India Pvt Ltd.
  Known for chemical intermediates, including glycine API for raw material sourcing, with an emphasis on purity and supply consistency.

3. European and North American Suppliers
While European and North American producers account for a smaller percentage of the global supply, they are recognized for compliance with stringent regulatory standards, especially for pharmaceutical applications:

• Evonik Industries AG (Germany)
  Offers pharmaceutical-grade amino acids, including glycine, manufactured under strict GMP standards with high purity profiles suitable for injectable and parenteral formulations.

• Shin-Etsu Chemical Co., Ltd. (Japan)
  Supplies amino acids with a focus on high-quality standards and regulatory compliance, although at a premium pricing point.

Regional Supply and Regulatory Considerations

Asia-Pacific: The dominant region for bulk glycine API production due to manufacturing capacity and lower costs. However, buyers must exercise diligence in quality audits and ensure compliance with local Good Manufacturing Practices (GMP) and International Conference on Harmonisation (ICH) guidelines to meet international standards.

Europe and North America: Focused on high-purity, pharmaceutical-grade glycine API, often complying with regulatory bodies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and EDQM (European Directorate for the Quality of Medicines & HealthCare). These sources are preferred for formulations requiring regulatory approval and critical dosing.

Quality Standards and Certifications

Manufacturers supplying glycine API to the pharmaceutical industry are expected to adhere to several quality standards:

• GMP Certification: Ensures production processes meet quality requirements for pharmaceuticals and minimizes contamination risks.
• Pharmacopoeial Compliance: API must meet the specifications outlined in pharmacopeias such as USP, EP, or IP.
• ISO Certifications: ISO 9001 and ISO 22000 certification attest to quality management systems and safety standards.
• Environmental and Ethical Compliance: E.g., REACH registration in Europe, to demonstrate safety and regulatory adherence.

Supply Chain Challenges and Due Diligence

The reliance on Asian manufacturing hubs presents supply chain risks such as regulatory variability, quality consistency, and geopolitical factors. Buyers must conduct thorough supplier audits, verify third-party testing reports, and ensure documentation compliance to mitigate risks. Strategic stockpiling and multi-source sourcing are recommended strategies to ensure uninterrupted supply.

Emerging Trends in Glycine API Sourcing

• Sustainable Production: Growing emphasis on eco-friendly manufacturing processes incorporating green chemistry principles.
• Customization and Specification Tailoring: Suppliers offering tailored glycine grades for specific applications, including pharmaceutical, nutraceutical, and feed sectors.
• Vertical Integration: Some large producers are investing in integrated supply chains from raw materials to finished API, enhancing quality control.

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Key Takeaways

• The bulk glycine API market is predominantly driven by Chinese and Indian manufacturers, offering competitive prices and large-scale production capacity.
• European and North American suppliers prioritize regulatory compliance and high purity standards suitable for pharmaceutical applications.
• Buyers must conduct rigorous due diligence, verify certifications, and consider supply chain resilience in procurement strategies.
• Evolving industry trends focus on sustainability, product customization, and vertical integration to meet diverse market demands.

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FAQs

1. Who are the top global suppliers of glycine API?
Chinese companies such as Jiangsu Hengshui Interchemical and Shanxi Guoxin Group dominate the market, complemented by Indian firms like Venkys India Ltd. and European suppliers like Evonik Industries.

2. What quality standards should I look for in glycine API?
Ensure suppliers comply with GMP standards, meet pharmacopeia specifications (USP, EP, IP), and hold relevant certifications such as ISO 9001.

3. How does regional regulation affect sourcing choices?
European and North American sources generally offer higher compliance assurance, making them suitable for highly regulated pharmaceuticals, while Asian suppliers provide cost-effective options requiring thorough validation.

4. What are recent trends influencing glycine API sourcing?
An increased focus on sustainable manufacturing, customized API grades, and supply chain diversification reflects evolving industry priorities.

5. What risks should buyers consider when sourcing glycine APIs?
Potential risks include quality variability, regulatory non-compliance, geopolitical instability, and supply disruptions, emphasizing the importance of supplier audits and quality assurance measures.

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References
[1] Grand View Research, "Amino Acids Market Analysis," 2022.
[2] Research and Markets, "Global Amino Acid Industry Report," 2021.
[3] U.S. Pharmacopeia, "NF Glycine Monograph," 2022.
[4] European Directorate for the Quality of Medicines & HealthCare (EDQM), "European Pharmacopoeia," 2022.