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Iron Dextran | CAS No: 9004-66-4 | GMP-certified suppliers
A medication that treats iron deficiency anemia in patients unable to use oral iron and replenishes iron stores in chronic kidney disease populations requiring erythropoietin therapy.
Therapeutic categories
Primary indications
- For treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible
- Also used to replenish body iron stores in Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) patients receiving or not receiving erythropoietin and in Hemodialysis Dependent (HDD-CKD) and Peritoneal Dialysis Dependent (PDD-CKD) - Chronic Kidney Disease patients receiving an erythropoietin
Product Snapshot
- Iron Dextran is available as an injectable solution and oral formulations including tablets and capsules
- It is indicated primarily for iron replenishment in patients with iron deficiency where oral administration is inadequate, including those with various forms of chronic kidney disease
- The product is approved for use in the US and Canadian markets, with approvals covering both human and veterinary applications
Clinical Overview
Clinically, iron dextran is employed to replenish iron stores in various patient populations, including those with confirmed iron deficiency anemia. It plays a crucial role in patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD), both receiving and not receiving erythropoietin, as well as in Hemodialysis Dependent (HDD-CKD) and Peritoneal Dialysis Dependent (PDD-CKD) populations undergoing erythropoietin therapy. Its use in these contexts addresses the increased iron demand associated with erythropoiesis stimulation and chronic kidney disease-related anemia.
Pharmacodynamically, iron is essential for hemoglobin synthesis and the formation of various heme and nonheme proteins. Iron dextran provides bioavailable iron, which compensates for iron-deficient erythropoiesis, thereby preventing or treating iron deficiency anemia. Following administration, the complex is cleared from plasma by the reticuloendothelial system. Hepatic and splenic macrophages enzymatically dissociate the complex into free iron and dextran. The liberated iron binds rapidly to storage proteins such as ferritin and hemosiderin or, to a lesser extent, to transferrin for systemic distribution, maintaining physiological iron homeostasis.
Key pharmacokinetic considerations include the reticuloendothelial processing of the complex and gradual iron release, which supports sustained replenishment of iron stores. Safety concerns revolve around hypersensitivity reactions, which may range from mild to severe anaphylactoid responses. Careful patient monitoring during administration is recommended, and test doses may be considered to mitigate risk.
Iron dextran is marketed under various brand names worldwide and continues to be a valuable option where oral iron is ineffective or not feasible. Its use is governed by established guidelines concerning dosage and administration routes.
For API procurement, sourcing must prioritize high purity and compliance with pharmacopeial standards, including control of molecular weight distribution and endotoxin levels inherent to dextran complexes. Suppliers should provide certification that ensures consistency, sterility, and batch-to-batch reproducibility to support safe and effective drug product manufacturing.
Identification & chemistry
| Generic name | Iron Dextran |
|---|---|
| Molecule type | Small molecule |
| CAS | 9004-66-4 |
| UNII | 95HR524N2M |
| DrugBank ID | DB00893 |
Pharmacology
| Summary | Iron dextran serves as an intravenous or intramuscular iron supplement to restore iron levels in patients with documented deficiency when oral iron is inadequate or not feasible. Upon administration, iron dextran is processed by the reticuloendothelial system, releasing iron that binds to ferritin, hemosiderin, or transferrin, thereby replenishing hemoglobin and iron stores. The pharmacodynamic action targets hemoglobin subunits and ferritin complexes, supporting erythropoiesis and iron homeostasis. |
|---|---|
| Mechanism of action | After iron dextran is injected, the circulating iron dextran is removed from the plasma by cells of the reticuloendothelial system, which split the complex into its components of iron and dextran. The iron is immediately bound to the available protein moieties to form hemosiderin or ferritin, the physiological forms of iron, or to a lesser extent to transferrin. This iron which is subject to physiological control replenishes hemoglobin and depleted iron stores. |
| Pharmacodynamics | Iron dextran is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. It is for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible. Iron is essential to the formation of hemoglobin and to the function and formation of other heme and nonheme compounds. Untreated depletion of iron stores leads to iron-deficient erythropoiesis and, in turn, to iron deficiency anemia. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Hemoglobin subunit beta | Humans | activator |
| Hemoglobin subunit alpha | Humans | activator |
| Ferritin heavy chain | Humans | other |
ADME / PK
| Absorption | The major portion of intramuscular injections of iron dextran is absorbed within 72 hours; most of the remaining iron is absorbed over the ensuing 3 to 4 weeks. |
|---|---|
| Half-life | 5 hours (some indications that it can be as long as 10 hours) |
| Protein binding | 100% (after release from dextran) |
| Metabolism | Dextran, a polyglucose, is either metabolized or excreted. |
| Route of elimination | Dextran, a polyglucose, is either metabolized or excreted. |
Formulation & handling
- Iron Dextran is available in multiple dosage forms including oral tablets, capsules, and parenteral solutions for intramuscular and intravenous administration.
- As a small molecule iron complex, it requires careful handling to ensure stability, especially in solution form for injectable use.
- Formulations must consider potential iron oxidation and maintain appropriate storage conditions to preserve efficacy.
Regulatory status
| Lifecycle | The API's key patent in the United States expired in September 2015, allowing for generic competition. It is currently marketed in the US and Canada, reflecting a mature market stage. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Iron Dextran includes multiple originator companies involved in production, with a diverse network of packagers supporting supply. Branded products primarily serve the US and Canadian markets, with several recognized brand names in circulation. The patent expired in 2015, indicating the presence of established generic competition in the marketplace. |
|---|
Safety
| Toxicity | LD<sub>50</sub> = 500 mg/kg (mouse, IV). Dosages of iron dextran in excess of the requirements for restoration of hemoglobin and replenishment of iron stores may lead to hemosiderosis. Cases of severe, sometimes fatal, allergic reactions (loss of consciousness, collapse, difficulty breathing, hives, swelling, or convulsions) and severe low blood pressure (hypotension) have been reported with the use of iron dextran. |
|---|
- Acute toxicity: LDâ‚…â‚€ = 500 mg/kg (mouse, IV)
- Potential for severe allergic reactions, including anaphylaxis and hypotension
- Excess dosing may cause iron overload leading to hemosiderosis
Iron Dextran is a type of Iron preparations
Iron preparations are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs). They are widely used in the treatment of iron-deficiency anemia and various other conditions related to iron deficiency. Iron is an essential mineral required for the production of hemoglobin, a protein responsible for carrying oxygen in the blood.
Iron preparations in the form of APIs are available in different formulations, including ferrous sulfate, ferrous fumarate, and ferrous gluconate. These formulations offer varying degrees of iron absorption and bioavailability. Ferrous sulfate is commonly used due to its high iron content and excellent absorption rate. Iron preparations are manufactured through a controlled process, ensuring their purity and consistency. The API production involves several stages, including raw material sourcing, chemical synthesis, and purification. Stringent quality control measures are implemented at each step to meet regulatory requirements and ensure the safety and efficacy of the final product.
Iron preparations API subcategory plays a crucial role in the pharmaceutical industry, as iron deficiency is a prevalent global health issue. These APIs are incorporated into various dosage forms such as tablets, capsules, and syrups, enabling convenient administration to patients. Additionally, they are often used in combination with other vitamins and minerals to enhance their therapeutic effects.
Overall, iron preparations APIs are indispensable in the treatment of iron deficiency and contribute significantly to improving the health and well-being of individuals worldwide. Pharmaceutical companies invest in research and development to further optimize these APIs' properties, making them more bioavailable and convenient for patient use.
Iron Dextran (Iron preparations), classified under Therapeutic Nutrients/Minerals/Electrolyte
Therapeutic Nutrients/Minerals/Electrolytes: A Comprehensive Technical DescriptionTherapeutic nutrients, minerals, and electrolytes are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to support and enhance overall health and well-being. These compounds play a crucial role in maintaining the body's physiological balance, aiding in various metabolic processes, and addressing specific deficiencies.
Therapeutic nutrients encompass a broad range of substances, including vitamins, minerals, and electrolytes. Vitamins are organic compounds required in small quantities for proper bodily functions and are essential for growth, development, and disease prevention. Minerals, on the other hand, are inorganic substances that support numerous physiological processes, such as bone formation, nerve function, and energy production.
Electrolytes are minerals that carry an electric charge when dissolved in bodily fluids, including sodium, potassium, calcium, magnesium, and chloride. They play a crucial role in maintaining proper hydration, nerve impulses, muscle contractions, and pH balance.
Pharmaceutical APIs in the Therapeutic Nutrients/Minerals/Electrolyte category are designed to address specific deficiencies or imbalances in the body. These APIs are often used in the formulation of dietary supplements, nutritional products, and therapeutic treatments. They are manufactured under stringent quality control guidelines to ensure purity, potency, and bioavailability.
Therapeutic nutrients/minerals/electrolytes APIs are available in various forms, including tablets, capsules, powders, and liquid formulations. They are formulated to meet specific dosage requirements and can be combined with other ingredients for targeted health benefits.
Overall, therapeutic nutrients, minerals, and electrolytes APIs are essential components in maintaining optimal health. Their use helps address deficiencies, support bodily functions, and promote overall well-being. Pharmaceutical companies and healthcare professionals rely on these high-quality APIs to develop effective and safe products that contribute to a healthier population.
Iron Dextran API manufacturers & distributors
Compare qualified Iron Dextran API suppliers worldwide. We currently have 5 companies offering Iron Dextran API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Mylan | Producer | India | India | CoA, USDMF | 201 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sichuan Kelun Pharmaceuti... | Producer | China | China | CoA | 6 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA | 762 products |
| Zhejiang Apeloa Tospo-Jia... | Producer | China | China | CoA, USDMF | 15 products |
When sending a request, specify which Iron Dextran 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 Iron Dextran 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.
