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Streptokinase | CAS No: 9002-01-1 | GMP-certified suppliers
A medication that supports rapid clot dissolution in acute myocardial infarction, pulmonary embolism, deep vein thrombosis, and other thrombotic blockages requiring timely restoration of blood flow.
Therapeutic categories
Primary indications
- For the treatment of acute evolving transmural myocardial infarction, pulmonary embolism, deep vein thrombosis, arterial thrombosis or emolism and occlusion of arteriovenous cannulae
Product Snapshot
- Streptokinase is supplied as a parenteral injectable biologic in powder or lyophilized powder formats for reconstitution
- It is used for thrombolytic applications including acute myocardial infarction, pulmonary embolism, deep vein thrombosis, arterial thrombosis, and arteriovenous cannula occlusion
- It is approved in Canada with additional investigational status in other markets
Clinical Overview
Pharmacologically, streptokinase acts by forming an active 1:1 complex with plasminogen. This complex induces cleavage at the Arg/Val bond of plasminogen, generating plasmin. Plasmin subsequently degrades fibrin structures within the thrombus and also hydrolyzes fibrinogen and various plasma proteins. The resulting fibrinolytic activity promotes clot dissolution and restoration of blood flow. Streptokinase has no intrinsic enzymatic activity but functions as a plasminogen activator through this complex-mediated mechanism.
Absorption, distribution, metabolism, and elimination parameters are influenced by its protein nature. Streptokinase is administered parenterally due to lack of oral bioavailability. It is rapidly cleared from circulation, with activity neutralized by endogenous inhibitors and by the development of antistreptococcal antibodies, which are common in individuals with prior streptococcal exposure. Immunogenicity can reduce therapeutic efficacy and may limit repeat administration.
Key safety considerations include bleeding risk, which correlates with systemic plasmin generation and degradation of circulating coagulation factors. Hypotension, allergic reactions, and antibody-mediated resistance may occur. Use requires careful evaluation of contraindications to thrombolysis and monitoring for hemorrhagic complications. Notable historical brands include formulations used in acute myocardial infarction and venous thromboembolism settings; availability varies by region due to evolving clinical practice and local guidelines.
For API procurement, sourcing should focus on verified microbial production controls, consistent protein purification, and rigorous characterization of activity and impurity profiles. Manufacturers should demonstrate validated processes that ensure potency, sterility, and minimized immunogenic contaminants.
Identification & chemistry
| Generic name | Streptokinase |
|---|---|
| Molecule type | Biotech |
| CAS | 9002-01-1 |
| UNII | 8X1OXL3SNU |
| DrugBank ID | DB00086 |
Pharmacology
| Summary | Streptokinase forms a 1:1 complex with plasminogen, inducing its conversion to plasmin and promoting degradation of fibrin, fibrinogen, and other plasma proteins. The resulting increase in plasmin activity dissolves fibrin clots central to thrombus structure. Its pharmacologic effects reflect enhanced fibrinolysis through plasminogen activation and downstream interactions that may involve proteinase‑activated receptor 1. |
|---|---|
| Mechanism of action | Plasminogen is an inactive molecule that becomes activated to plasmin when the Arg/Val bond is cleaved. Plasmin breaks down fibrin clots created by the blood clotting cascade. Streptokinase forms a highly specific 1:1 enzymatic complex with plasminogen which converts inactive plasminogen molecules into active plasmin. Plasmin degrades fibrin clots as well as fibrinogen and other plasma proteins. This in turn leads to the degradation of blood clots. |
| Pharmacodynamics | Streptokinase creates an active complex which promotes the cleavage of the Arg/Val bond in plasminogen to form the proteolytic enzyme plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action. This helps eliminate blood clots or arterial blockages that cause myocardial infarction. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Plasminogen | Humans | activator |
| Proteinase-activated receptor 1 | Humans | activator |
Formulation & handling
- Streptokinase is a protein-based biotech thrombolytic supplied as lyophilized or liquid material for reconstitution, intended solely for parenteral (IV or intracoronary) administration.
- Being a biologic protein, it requires gentle handling, protection from excessive heat, and avoidance of agitation to maintain activity during reconstitution and transfer.
- Formulation work must consider proteolytic and stability sensitivity of the enzyme and potential interactions with excipients that could affect protein integrity or fibrinolytic activity.
Regulatory status
| Lifecycle | Patent protection for the API in Canada has lapsed or is nearing expiry, indicating a transition toward a mature market environment. As exclusivity ends, Canadian availability is expected to reflect increasing generic presence and stabilized competition. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | Streptokinase is an established thrombolytic with one historical originator‑linked supplier listed, primarily associated with branded products such as Kabikinase and Streptase. Its branded presence has been global in the past, though currently represented here only in the Canadian market. Patent expiry occurred long ago, so manufacturing generally relies on non‑proprietary production with broad potential for existing or expanded generic competition. |
|---|
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Streptokinase is a type of Thrombolytics
Thrombolytics, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in the field of medicine, particularly in the treatment of thrombotic disorders. Thrombolytics are highly effective in dissolving blood clots that form within blood vessels, thereby restoring blood flow and preventing potential complications.
These pharmaceutical agents work by activating the body's natural fibrinolytic system, which is responsible for breaking down fibrin, a protein involved in clot formation. Thrombolytics primarily target specific components of the clot, such as plasminogen, and convert them into active enzymes called plasmin. Plasmin subsequently degrades fibrin, leading to clot dissolution.
The therapeutic application of thrombolytics is vast, encompassing conditions like acute myocardial infarction (heart attack), deep vein thrombosis, pulmonary embolism, and ischemic stroke. Rapid administration of these APIs is critical to maximize their effectiveness and minimize the risk of complications.
Thrombolytics are available in various forms, including injectable formulations that can be administered intravenously or directly at the site of clot formation. Different thrombolytic agents, such as alteplase, tenecteplase, and reteplase, possess unique pharmacokinetic profiles and varying abilities to dissolve clots.
It is crucial to note that thrombolytics require careful monitoring and should be administered under the guidance of medical professionals due to potential adverse effects, such as bleeding complications. Therefore, their usage is strictly regulated, and patient-specific factors are considered before initiating thrombolytic therapy.
In summary, thrombolytics are an essential subclass of pharmaceutical APIs that effectively dissolve blood clots, restoring blood flow and preventing complications associated with thrombotic disorders. Their therapeutic application spans various medical conditions, and their administration should be carefully managed to ensure patient safety.
Streptokinase (Thrombolytics), classified under Anticoagulants
Anticoagulants are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to prevent and treat blood clotting disorders. These medications play a crucial role in various medical conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AF). Anticoagulants work by inhibiting the formation of blood clots or by preventing existing clots from getting larger.
There are different types of anticoagulants available, including direct thrombin inhibitors, vitamin K antagonists, and factor Xa inhibitors. Direct thrombin inhibitors, such as dabigatran, directly target the enzyme thrombin to hinder clot formation. Vitamin K antagonists, like warfarin, interfere with the production of clotting factors that rely on vitamin K. Factor Xa inhibitors, such as rivaroxaban and apixaban, inhibit the activity of factor Xa, a crucial component in the clotting cascade.
Anticoagulants are commonly prescribed to patients at risk of developing blood clots or those with existing clotting disorders. They are often used during surgeries, such as hip or knee replacements, to minimize the risk of post-operative clot formation. Patients with AF, a condition characterized by irregular heart rhythm, may also be prescribed anticoagulants to prevent stroke caused by blood clots.
While anticoagulants offer significant benefits in preventing and treating clot-related conditions, they also carry potential risks, including bleeding complications. Patients taking anticoagulants require careful monitoring to ensure the right dosage is administered, as excessive anticoagulation can lead to hemorrhage. Regular blood tests and close medical supervision are essential to manage the delicate balance between preventing clots and avoiding excessive bleeding.
In conclusion, anticoagulants are a crucial category of pharmaceutical APIs used to prevent and treat blood clotting disorders. They function by inhibiting clot formation or preventing existing clots from enlarging. While highly beneficial, their use requires careful monitoring to minimize the risk of bleeding complications.
Streptokinase API manufacturers & distributors
Compare qualified Streptokinase API suppliers worldwide. We currently have 1 companies offering Streptokinase API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Kraeber & Co GmbH | Producer | Germany | Germany | CoA, GDP, GMP, ISO9001, MSDS | 12 products |
When sending a request, specify which Streptokinase 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 Streptokinase 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.
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Technical
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Regulatory
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