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Tranexamic acid | CAS No: 1197-18-8 | GMP-certified suppliers
A medication that helps manage heavy menstrual bleeding, hereditary angioedema, and various bleeding conditions including hemophilia-related episodes for reliable control in high-fibrinolysis settings.
Therapeutic categories
Acids, CarbocyclicAmino AcidsAmino Acids, Peptides, and ProteinsAntifibrinolytic AgentsBlood and Blood Forming OrgansCoagulants
Generic name
Tranexamic acid
Molecule type
small molecule
CAS number
1197-18-8
DrugBank ID
DB00302
Approval status
Approved drug
ATC code
B02AA02
Primary indications
- Taken orally, tranexamic acid is indicated for the treatment of hereditary angioedema,cyclic heavy menstrual bleeding in premenopausal females,and other instances of significant bleeding in the context of hyperfibrinolysis
- Given intravenously, tranexamic acid is indicated for short-term use (2-8 days) in patients with hemophilia to prevent or reduce bleeding following tooth extraction
Product Snapshot
- Tranexamic acid is available as an oral small molecule and as injectable and topical formulations for parenteral and local use
- It is used for management of hyperfibrinolysis-related bleeding, including heavy menstrual bleeding, hereditary angioedema–associated episodes, and bleeding in hemophilia patients after dental procedures
- It is approved in the US and Canada
Clinical Overview
Tranexamic acid (CAS 1197-18-8) is a synthetic lysine analogue classified among amino acids and used as an antifibrinolytic agent. It is indicated for controlling or preventing bleeding associated with excessive fibrinolysis. Oral therapy is approved for hereditary angioedema, cyclic heavy menstrual bleeding in premenopausal females, and other bleeding states driven by hyperfibrinolysis. Intravenous administration is used short term in patients with hemophilia to reduce post‑extraction bleeding. The compound was patented in 1957 and first approved in the United States in 1986.
Tranexamic acid exerts its pharmacologic effects by competitively inhibiting plasminogen activation to plasmin. At therapeutic concentrations, it blocks multiple low‑affinity and one high‑affinity binding site on plasminogen, including the high‑affinity site involved in fibrin binding. By preventing plasminogen–fibrin interaction, it reduces fibrinolysis and stabilizes fibrin clots. At higher concentrations it can act as a noncompetitive inhibitor of plasmin. Its potency is approximately tenfold higher than aminocaproic acid.
Pharmacokinetic characteristics include good oral absorption, minimal metabolism, and predominant renal elimination. Plasma half‑life is generally short, supporting dosing at regular intervals. Accumulation can occur in renal impairment due to reduced clearance, requiring dose adjustment to avoid toxicity.
Safety considerations include the risk of thrombotic events in susceptible patients, although the drug does not directly induce coagulation. Off‑target antagonism of GABA(A) receptors has been associated with seizures, particularly with high doses, inadvertent intrathecal administration, or use during cardiovascular surgery. Patients with a history of seizures may require additional monitoring. Adverse effects may include gastrointestinal symptoms or transient visual disturbances.
Tranexamic acid is available globally in oral and parenteral formulations, with branded and nonbranded products used across surgical, hematologic, and gynecologic settings.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and residual solvent levels, supported by current GMP certification and region‑appropriate regulatory documentation.
Tranexamic acid exerts its pharmacologic effects by competitively inhibiting plasminogen activation to plasmin. At therapeutic concentrations, it blocks multiple low‑affinity and one high‑affinity binding site on plasminogen, including the high‑affinity site involved in fibrin binding. By preventing plasminogen–fibrin interaction, it reduces fibrinolysis and stabilizes fibrin clots. At higher concentrations it can act as a noncompetitive inhibitor of plasmin. Its potency is approximately tenfold higher than aminocaproic acid.
Pharmacokinetic characteristics include good oral absorption, minimal metabolism, and predominant renal elimination. Plasma half‑life is generally short, supporting dosing at regular intervals. Accumulation can occur in renal impairment due to reduced clearance, requiring dose adjustment to avoid toxicity.
Safety considerations include the risk of thrombotic events in susceptible patients, although the drug does not directly induce coagulation. Off‑target antagonism of GABA(A) receptors has been associated with seizures, particularly with high doses, inadvertent intrathecal administration, or use during cardiovascular surgery. Patients with a history of seizures may require additional monitoring. Adverse effects may include gastrointestinal symptoms or transient visual disturbances.
Tranexamic acid is available globally in oral and parenteral formulations, with branded and nonbranded products used across surgical, hematologic, and gynecologic settings.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and residual solvent levels, supported by current GMP certification and region‑appropriate regulatory documentation.
Identification & chemistry
| Generic name | Tranexamic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 1197-18-8 |
| UNII | 6T84R30KC1 |
| DrugBank ID | DB00302 |
Pharmacology
| Summary | Tranexamic acid is an antifibrinolytic agent that competitively inhibits plasminogen activation, reducing plasmin formation and stabilizing fibrin clots. Its activity is driven by high‑affinity binding to plasminogen sites involved in fibrin interaction, with secondary inhibition of plasmin at higher concentrations. Off‑target antagonism of GABA(A) receptors has been associated with seizure risk. |
|---|---|
| Mechanism of action | Tranexamic acid competitively and reversibly inhibits the activation of plasminogen via binding at several distinct sites, including four or five low-affinity sites and one high-affinity site, the latter of which is involved in its binding to fibrin. The binding of plasminogen to fibrin induces fibrinolysis - by occupying the necessary binding sites tranexamic acid prevents this dissolution of fibrin, thereby stabilizing the clot and preventing hemorrhage. |
| Pharmacodynamics | Tranexamic acid is an antifibrinolytic that competitively inhibits the activation of plasminogen to plasmin.At much higher concentrations it behaves as a noncompetitive inhibitor of plasmin similar to [aminocaproic acid], a similar antifibrinolytic which is 10-fold less potent.Tranexamic acid binds more strongly than aminocaproic acid to both the strong and weak receptor sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds. In patients with hereditary angioedema, inhibition of the formation and activity of plasmin by tranexamic acid may prevent attacks of angioedema by decreasing plasmin-induced activation of the first complement protein (C1). Off-target antagonism of GABA(A) receptors may be associated with the development of convulsions and hyperexcitability following tranexamic acid administration- the risk appears higher with improper administration or administration during cardiovascular surgery.Consider EEG monitoring of patients with a history of seizure. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Plasminogen | Humans | inhibitor |
ADME / PK
| Absorption | The bioavailability of tranexamic acid after oral administration in humans is approximately 30 to 50% of the ingested dose and is not affected by food intake.The C<sub>max</sub> and T<sub>max</sub> following multiple oral doses (1300 mg three times daily x 5 days) were 16.41 mcg/mL and 2.5 h, respectively. |
|---|---|
| Half-life | Following intravenous administration, the apparent elimination half-life is approximately 2 hours and the mean terminal half-life is approximately 11 hours. |
| Protein binding | Tranexamic acid is approximately 3% protein-bound in plasma at therapeutic concentrations. As it does not bind to serum albumin, it is likely that this protein binding is accounted for by tranexamic acid's binding to serum plasminogen. |
| Metabolism | Tranexamic acid metabolism is poorly characterized but does not appear to be a significant means of drug elimination. According to prescribing information, approximately 1% and 0.5% of an orally administered dose are excreted as a dicarboxylic acid and acetylated metabolite, respectively. |
| Route of elimination | Urinary excretion is the primary means of tranexamic acid elimination, with >95% of an administered dose excreted in the urine as unchanged parent drug.The rate of excretion is dependent on the route of administration - approximately 90% of an intravenously administered dose is excreted within 24 hours whereas only 39% of an orally administered dose is excreted within the same time frame. |
| Volume of distribution | The initial volume of distribution of tranexamic acid is 0.18 L/kg and its steady-state volume of distribution is 0.39 L/kg.Tranexamic acid distributes into cerebrospinal fluid and the aqueous humor of the eye at concentrations approximately 1/10th of typical plasma concentrations. Tranexamic acid is also able to cross the placenta, found in cord blood at concentrations equivalent to maternal plasma concentrations. |
| Clearance | The plasma clearance of tranexamic acid is 110-116 mL/min. |
Formulation & handling
- Oral formulations are straightforward given high aqueous solubility and no meaningful food effect, allowing simple immediate‑release designs.
- Injectable products are typically aqueous solutions; the highly water‑soluble, zwitterionic small molecule supports stable IV formulations with minimal solubilization aids.
- Topical forms use the solid, hydrophilic API in solution or cream bases, with routine protection from microbial contamination and normal aqueous‑solution stability considerations.
Regulatory status
| Lifecycle | Patent protection in the United States is scheduled to expire in March 2025, indicating an approaching loss‑of‑exclusivity period. With current commercialization limited to the US and Canada, the API is transitioning toward a more mature market environment as generics may enter following expiry. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Tranexamic acid is supplied by a small number of originator manufacturers, with additional participation from several packagers that support distribution in the US and Canada. Branded products such as Cyklokapron and Erfa‑tranexamic indicate established market presence in North America. Multiple US patents expiring in 2025 suggest that generic competition is existing in some markets and may further expand as protections lapse. |
|---|
Safety
| Toxicity | Reported symptoms of tranexamic acid overdose include severe gastrointestinal symptoms, hypotension, thromboembolism, visual impairment, convulsions, mental status changes, and rash. |
|---|
High Level Warnings:
- Overexposure may elicit pronounced gastrointestinal distress, hypotension, and CNS effects including convulsions and altered mental status
- High systemic levels have been associated with thromboembolic risk and transient visual disturbances
- Dermatologic reactions such as rash have been reported in overdose contexts and may indicate excessive exposure
Tranexamic Acid is a type of Antifibrinolytics
Antifibrinolytics belong to a vital category of pharmaceutical active pharmaceutical ingredients (APIs) utilized in the medical field. These compounds play a crucial role in preventing excessive bleeding by inhibiting the breakdown of blood clots. By promoting clot stability, antifibrinolytics help control bleeding, particularly in situations where there is a risk of uncontrolled hemorrhage.
One well-known antifibrinolytic agent is tranexamic acid, which is widely employed in various medical procedures, including surgery, trauma management, and dental procedures. This API works by binding to plasminogen, a protein involved in the dissolution of blood clots, and preventing its conversion to plasmin, the enzyme responsible for clot degradation.
Another prominent antifibrinolytic is aminocaproic acid, which acts in a similar manner to tranexamic acid. It competitively inhibits the activation of plasminogen, thereby preserving the integrity of formed clots.
Antifibrinolytics find applications in several medical specialties, such as orthopedics, cardiovascular surgery, and gynecology. They are particularly valuable in managing bleeding disorders, such as hemophilia and menorrhagia, as well as in minimizing blood loss during major surgical procedures.
As with any pharmaceutical API, the production and use of antifibrinolytics require adherence to strict quality control standards and regulatory guidelines to ensure their safety and efficacy. Healthcare professionals should carefully assess each patient's condition and consider potential contraindications or interactions before prescribing or administering antifibrinolytic medications.
In conclusion, antifibrinolytics play a crucial role in preventing excessive bleeding by inhibiting clot breakdown. These pharmaceutical APIs, such as tranexamic acid and aminocaproic acid, are widely used in various medical procedures and provide valuable therapeutic options for managing bleeding disorders and minimizing blood loss during surgeries.
Tranexamic Acid API manufacturers & distributors
Compare qualified Tranexamic Acid API suppliers worldwide. We currently have 17 companies offering Tranexamic Acid API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ALP PHARM | Producer | China | China | CoA, USDMF | 33 products |
| Aquatic Remedies Pvt Ltd | Producer | India | India | CoA | 35 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Asahi Gelatine | Producer | Japan | Japan | CEP, CoA | 2 products |
| Asahi Kasei | Producer | Japan | Japan | CoA, JDMF | 3 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Changzhou Yinsheng | Producer | China | China | CoA, JDMF, WC | 1 products |
| ChemPacific | Producer | United States | China | CoA, WC | 10 products |
| CMIC Cmo | Producer | Japan | Japan | CEP, CoA, USDMF | 1 products |
| Duchefa Farma B.V. | Distributor | Netherlands | China | CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Kyowa Pharma Chem. | Producer | Japan | Japan | CEP, CoA, FDA, JDMF, USDMF | 12 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Malladi Drugs & Pharma | Producer | India | India | CoA, GMP | 14 products |
| Ouchi Shinko Chemical Ind... | Producer | Japan | Japan | CoA, JDMF | 4 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 54 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
When sending a request, specify which Tranexamic Acid API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Tranexamic Acid API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Tranexamic Acid API
Sourcing
What matters most when sourcing GMP-grade Tranexamic Acid?
Key considerations include confirming GMP compliance and ensuring the Tranexamic Acid is sourced from manufacturers or packagers with appropriate regulatory qualifications for the US and Canada. Because only a small number of originators and several packagers supply the region, evaluating supply reliability is important. Established branded products indicate an existing compliant supply chain, which should be verified through documentation.
Which documents are typically required when sourcing Tranexamic Acid API?
Request the core API documentation set: CoA (18 companies), CEP (9 companies), USDMF (9 companies), MSDS (8 companies), GMP (8 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Tranexamic Acid API?
Known or reported manufacturers for Tranexamic Acid: Duchefa Farma B.V., Xi'an Tian Guangyuan Biotech Co.,Ltd, Aurora Industry Co., Ltd, Sinoway industrial Co.,Ltd, Arshine Pharmaceutical Co., Limited, LGM Pharma, Shilpa Medicare Ltd, Rochem International, Inc.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Tranexamic Acid API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Tranexamic Acid manufacturers?
Audit reports may be requested for Tranexamic Acid: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Tranexamic Acid API on Pharmaoffer?
Reported supplier count for Tranexamic Acid: 18 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Tranexamic Acid API?
Production countries reported for Tranexamic Acid: China (8 producers), Japan (5 producers), India (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Tranexamic Acid usually hold?
Common certifications for Tranexamic Acid suppliers: CoA (18 companies), CEP (9 companies), USDMF (9 companies), MSDS (8 companies), GMP (8 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Tranexamic Acid (CAS 1197-18-8) used for?
Tranexamic Acid is an antifibrinolytic agent used to prevent or control bleeding caused by excessive fibrinolysis. It is used orally for hereditary angioedema, cyclic heavy menstrual bleeding in premenopausal females, and other hyperfibrinolytic states. Intravenous dosing is used short term in patients with hemophilia to reduce bleeding after dental extraction.
Which therapeutic class does Tranexamic Acid fall into?
Tranexamic Acid belongs to the following therapeutic categories: Acids, Carbocyclic, Amino Acids, Amino Acids, Peptides, and Proteins, Antifibrinolytic Agents, Blood and Blood Forming Organs. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Tranexamic Acid mainly prescribed for?
The primary indications for Tranexamic Acid: Taken orally, Tranexamic Acid is indicated for the treatment of hereditary angioedema,cyclic heavy menstrual bleeding in premenopausal females,and other instances of significant bleeding in the context of hyperfibrinolysis, Given intravenously, Tranexamic Acid is indicated for short-term use (2-8 days) in patients with hemophilia to prevent or reduce bleeding following tooth extraction. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Tranexamic Acid work?
Tranexamic Acid competitively and reversibly inhibits the activation of plasminogen via binding at several distinct sites, including four or five low-affinity sites and one high-affinity site, the latter of which is involved in its binding to fibrin. The binding of plasminogen to fibrin induces fibrinolysis - by occupying the necessary binding sites Tranexamic Acid prevents this dissolution of fibrin, thereby stabilizing the clot and preventing hemorrhage.
What should someone know about the safety or toxicity profile of Tranexamic Acid?
Tranexamic Acid’s safety profile is characterized mainly by dose‑related gastrointestinal symptoms, transient visual disturbances, and dermatologic reactions with excessive exposure. High systemic levels can increase the risk of thromboembolic events and provoke CNS effects, including seizures linked to off‑target GABA(A) receptor antagonism. Rapid intravenous administration may cause hypotension, and patients with renal impairment may accumulate the drug, increasing toxicity risk. Monitoring is advised in individuals with seizure history or other conditions that heighten susceptibility to adverse effects.
What are important formulation and handling considerations for Tranexamic Acid as an API?
Important considerations include using its high aqueous solubility to support simple immediate‑release oral tablets or capsules and straightforward aqueous injectable solutions without special solubilizers. The API is hydrophilic and stable in water, so routine control of pH and microbial contamination is required, particularly for topical and multi‑dose formulations. Its zwitterionic nature supports solution stability, but standard measures to prevent precipitation and maintain clarity in injectables are necessary. Handling generally involves normal precautions for hygroscopic, water‑soluble solids.
Is Tranexamic Acid a small molecule?
Tranexamic Acid is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Tranexamic Acid?
Oral Tranexamic Acid has no special stability concerns beyond routine protection from moisture common to highly water‑soluble compounds. Its physicochemical profile supports simple immediate‑release formulations without the need for solubilization aids. Standard measures to maintain tablet or capsule integrity are generally sufficient.
Regulatory
Where is Tranexamic Acid approved or in use globally?
Tranexamic Acid is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Tranexamic Acid right now?
Tranexamic Acid is approved for use in both the United States and Canada. It is an older, well‑established active ingredient and is broadly available in generic form, with no active product‑specific patents generally associated with its core molecule. Regulatory oversight in both markets follows standard requirements for quality, safety, and bioequivalence for generic formulations.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Tranexamic Acid procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Tranexamic Acid. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Tranexamic Acid included in the PRO Data Insights coverage?
PRO Data Insights coverage for Tranexamic Acid: 3042 verified transactions across 796 suppliers and 522 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Tranexamic Acid?
Market report availability for Tranexamic Acid: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
