Bulk Pharmaceutical API Sources for TRANEXAMIC ACID

Bulk Pharmaceutical API Sources for TRANEXAMIC ACID

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		857653_ALDRICH
Alinda Chemical Trade Company Ltd		ALBB-006013
Vitas-M Laboratory		STK503668
TCI (Tokyo Chemical Industry)		A2121
TCI (Tokyo Chemical Industry)		A0236
Molport		MolPort-001-792-390
Molport		MolPort-002-512-008

Bulk Active Pharmaceutical Ingredient (API) Sources for: Tranexamic Acid

Last updated: July 29, 2025

Introduction

Tranexamic acid (TXA) is a synthetic derivative of the amino acid lysine, widely utilized in clinical settings for its antifibrinolytic properties. It plays a crucial role in controlling hemorrhage, preventing excessive blood loss, and managing various bleeding disorders. The global demand for TXA has surged, driven by its applications in trauma, surgery, and obstetrics. Accurate sourcing of bulk active pharmaceutical ingredients (APIs) such as TXA is vital for pharmaceutical manufacturers, ensuring quality, compliance, and reliable supply. This article explores the primary international sources of bulk TXA, emphasizing key manufacturers, geographic distribution, quality standards, and supply chain considerations.

Global Market Overview of Tranexamic Acid API

The global market for TXA is characterized by a handful of established manufacturers, primarily based in China, India, and Europe. China remains the dominant supplier, with several well-known API producers offering bulk TXA compliant with international standards such as USP, EP, and ICH guidelines. India also ranks prominently as a key API manufacturing hub, with several companies producing high-quality TXA for export. European manufacturers, although fewer, focus heavily on quality, regulatory compliance, and supply stability.

Leading Manufacturers and Suppliers of Bulk Tranexamic Acid API

1. Chinese API Manufacturers

• Shandong Eureka Pharmaceutical Co., Ltd.
  Known for its broad portfolio of pharmaceutical APIs, Eureka Pharmaceutical offers bulk TXA meeting global quality standards. They possess advanced manufacturing facilities equipped for large-scale production and have obtained certifications including GMP, ISO, and other regional standards. Their strategic location enables cost-effective production with rapid distribution.

• Hubei Hongcheng Pharmaceutical Co., Ltd.
  A major Chinese API producer, Hongcheng specializes in hemostatic agents, including TXA. Their manufacturing process incorporates robust quality control measures, ensuring consistent API quality aligned with pharmacopeial standards.

• Qingdao Eney Pharmaceutical Co., Ltd.
  This company supplies bulk TXA primarily for the export market. They focus on compliance with international quality norms and provide comprehensive documentation, including COAs and stability data. Their manufacturing facilities adhere to GMP guidelines.

2. Indian API Manufacturers

• BASF India Ltd. (via contracting manufacturing)
  Although BASF is globally recognized for specialty chemicals, they collaborate with Indian manufacturing units that produce TXA under stringent quality parameters, supporting global distribution.

• Glenmark Pharmaceuticals
  An Indian pharmaceutical innovator, Glenmark produces high-quality APIs, including TXA, catering to both domestic and international customers. Their facilities are accredited with WHO-GMP and other certification standards.

• Lupin Limited
  A well-established Indian API producer, Lupin offers bulk TXA for various markets with a focus on regulatory compliance and quality assurance.

3. European and Other Notable Suppliers

• Hlef Pharma GmbH (Germany)
  Known for high-quality APIs with a focus on rigorous quality management systems, Hlef Pharma supplies TXA primarily to the European market, emphasizing compliance with EMA standards.

• Aarti Industries Ltd. (India)
  Aarti Industries produces and supplies pharmaceutical intermediates and APIs, including TXA, with an emphasis on quality control, ISO certifications, and regulatory adherence.

Supply Chain Considerations

The sourcing of TXA APIs from these manufacturers requires thorough evaluation of several factors:

• Regulatory Compliance: Ensure suppliers meet international standards such as USP, EP, and conform to Good Manufacturing Practices (GMP).
• Quality Assurance: Verify Certificates of Analysis (COA), stability data, and batch consistency.
• Capacity and Lead Time: Confirm production capacity aligns with demand forecasts and consider supply chain resilience.
• Price Competitiveness: Balance cost considerations with quality and regulatory adherence.
• Geographic Location: Consider geopolitical stability, shipping logistics, and import/export regulations that could impact supply continuity.

Emerging Trends in API Sourcing for TXA

The pharmaceutical industry’s push towards increased transparency and quality has driven manufacturers to adopt advanced quality assurance systems, including digital traceability and batch transparency. Additionally, the ongoing impact of geopolitical shifts and trade regulations influences procurement strategies, favoring diversified sourcing that balances risk and cost. The adoption of ISO 9001, GMP, and ISO certifications among suppliers continues to serve as a baseline for supplier evaluation.

Challenges in Bulk API Sourcing

• Regulatory Variability: Different markets enforce varying standards (e.g., FDA, EMA, CFDA), complicating supplier qualification.
• Quality Assurance: Variability in API purity, residual solvents, and compliance with pharmacopeial monographs can pose quality risks.
• Supply Chain Disruptions: Pandemics, geopolitical tensions, and trade restrictions can delay or disrupt supply chains.
• Pricing Pressures: Competitive markets exert downward pressure on prices, sometimes at the expense of quality.

Quality and Regulatory Standards for TXA API

Suppliers must demonstrate compliance with recognized standards such as:

• United States Pharmacopeia (USP) standards for purity, potency, and stability.
• European Pharmacopoeia (EP) specifications.
• International Conference on Harmonisation (ICH) guidelines for quality, safety, and efficacy.
• GMP certification to attest to manufacturing practices.

Rigorous documentation, including Batch Production Records, COAs, and stability data, is essential for regulatory submissions and audit readiness. Certification processes, such as approval by relevant health authorities, are critical indicators of supplier credibility.

Conclusion

The sourcing of bulk tranexamic acid API remains concentrated among a handful of reputed producers primarily in China, India, and Europe. Manufacturing capabilities, adherence to quality standards, and supply chain resilience determine supplier selection. Pharmaceutical companies should establish robust qualification processes, emphasizing compliance with international standards, quality assurance, and delivery reliability. Diversification of suppliers can mitigate risks associated with geopolitical and regulatory fluctuations.

Key Takeaways

• The primary global sources for TXA API are in China, India, and Europe, with leading manufacturers adhering to GMP and pharmacopeial standards.
• Suppliers should provide comprehensive documentation, including COAs, stability data, and certifications, to ensure quality and regulatory compliance.
• Supply chain resilience can be enhanced by diversifying sourcing strategies, considering geopolitical stability, and maintaining multiple supplier relationships.
• Continuous monitoring of regulatory updates and quality standards is essential for maintaining compliance and market access.
• Technological advancements, such as digital traceability, are increasingly integral to API sourcing strategies.

---

FAQs

1. What are the key criteria when selecting a bulk TXA API supplier?
Quality compliance with pharmacopeial standards, GMP certification, reliable supply capacity, transparent documentation, and adherence to regulatory standards are essential.

2. How does geographic location impact API sourcing for TXA?
Location influences lead times, regulatory considerations, geopolitical stability, and logistical costs; diversification minimizes risks associated with regional disruptions.

3. What certifications should I verify before sourcing TXA API?
GMP, ISO 9001, ISO 9002, and certificates aligned with USP, EP, ICH, and other pharmacopeial standards ensure quality and regulatory compliance.

4. What are the potential risks in bulk API sourcing for TXA?
Risks include quality variability, regulatory non-compliance, supply chain disruptions, and price fluctuations.

5. How is the quality of TXA API typically verified?
Through Certificates of Analysis, batch records, stability data, and audits of the manufacturing facilities, as well as periodic surveillance testing.

---

Sources

1. [1] WHO. WHO Good Manufacturing Practices (GMP) Guidelines for APIs.
2. [2] U.S. Pharmacopeia Official Website. Specifications for Tranexamic Acid.
3. [3] European Pharmacopoeia. Monograph on Tranexamic Acid.
4. [4] Industry reports on API manufacturing in China and India.
5. [5] Regulatory filings and certification documents from major API suppliers.