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Deferiprone | CAS No: 30652-11-0 | GMP-certified suppliers
A medication that treats transfusional iron overload in thalassemia patients by chelating excess iron to prevent organ damage when first-line agents are insufficient.
Therapeutic categories
Primary indications
- Deferiprone is indicated in thalassemia syndromes when first line chelation agents are not adequate to treat transfusional iron overload
Product Snapshot
- Deferiprone is an oral small molecule available in multiple tablet and solution formulations
- It is primarily used for chelation therapy in thalassemia syndromes to manage transfusional iron overload when first-line agents are insufficient
- The product is approved for use in key regulatory markets including the US, EU, and Canada
Clinical Overview
Pharmacologically, deferiprone belongs to the methylpyridine class of compounds, which feature a pyridine ring substituted with methyl groups. It acts by selectively binding ferric iron (Fe3+) ions with a stoichiometry of three deferiprone molecules to one iron ion, forming a stable complex. This complex is primarily excreted via the urine, enabling removal of excess iron from the body. Deferiprone demonstrates higher selectivity for iron relative to other biologically relevant metals such as zinc, copper, and aluminum.
Absorption of deferiprone occurs following oral administration, with subsequent metabolism involving conjugation by hepatic enzymes including UGT1A6. The drug is eliminated predominantly by renal excretion, necessitating consideration of renal function in dosing.
Safety and toxicity profiles indicate that deferiprone use requires monitoring for adverse effects, including neutropenia and agranulocytosis, which can be serious and necessitate regular hematological surveillance. Liver function and renal status should also be monitored during therapy.
Deferiprone was granted FDA approval on October 14, 2011, as a second-line treatment option when first-line chelators such as deferoxamine are inadequate. It is marketed under various brand names globally and is an established component of iron chelation protocols in thalassemia care.
From an API sourcing perspective, stringent quality control is imperative to ensure purity and consistency, particularly regarding residual solvents and heavy metal contaminants. Manufacturers should verify compliance with pharmacopeial standards and regulatory requirements to meet clinical safety standards and ensure reproducibility in pharmaceutical formulations.
Identification & chemistry
| Generic name | Deferiprone |
|---|---|
| Molecule type | Small molecule |
| CAS | 30652-11-0 |
| UNII | 2BTY8KH53L |
| DrugBank ID | DB08826 |
Pharmacology
| Summary | Deferiprone is an iron chelating agent that selectively binds ferric ions to form a stable complex excreted via urine. It primarily targets excess iron accumulation, reducing iron overload in conditions such as thalassemia syndromes. The compound exhibits lower affinity for other metals like zinc, copper, and aluminum. |
|---|---|
| Mechanism of action | Deferiprone is an iron chelator that binds to ferric ions (iron III) and forms a 3:1 (deferiprone:iron) stable complex and is then eliminated in the urine. Deferiprone is more selective for iron in which other metals such as zinc, copper, and aluminum have a lower affinity for deferiprone. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Iron | Humans | chelator |
ADME / PK
| Absorption | Deferiprone is absorbed in the upper gastrointestinal tract. Absorption is rapid with maximum plasma concentrations occurring after 1 hour in the fasted state and after 2 hours in the fed state. |
|---|---|
| Half-life | The half-life is 1.9 hours. |
| Protein binding | Plasma protein binding is less than 10%. |
| Metabolism | Deferiprone is mainly metabolized by UGT1A6 to the 3-O-glucuronide metabolite. This metabolite cannot chelate iron. |
| Route of elimination | Within 5-6 hours of administration, more than 90% of deferiprone is eliminated from the plasma. 75 to 90% of deferiprone is excreted in the urine as the metabolite. |
| Volume of distribution | In healthy patients, the volume of distribution is 1L/kg, and in thalassemia patients, the volume of distribution is 1.6L/kg. |
Formulation & handling
- Deferiprone is a small molecule drug intended for oral administration in various solid and liquid dosage forms.
- It exhibits moderate water solubility (273 g/L) and low lipophilicity (LogP 0.61), facilitating formulation in aqueous media.
- Food intake does not impact its absorption, allowing flexibility in dosing relative to meals.
Regulatory status
| Lifecycle | The API is marketed in the US, EU, and Canada, with initial key patents expired in the US as of June 2021, while additional US patents remain in effect through 2038, indicating ongoing market protection and extended lifecycle in that region. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Deferiprone includes multiple originator companies supplying branded products across the US, EU, and Canadian markets. Several patents are active in the United States, with expiration dates extending through 2038, indicating that generic competition is currently limited or anticipated in the longer term. This suggests a sustained presence of branded products with restricted immediate generic entry. |
|---|
Safety
| Toxicity | Agranulocytosis and neutropenia may occur, which can lead to fatal infections. Hepatoxicity is also possible. Most common side effects that lead to discontinuation of therapy were the gastrointestinal adverse effects (diarrhea, ulcer, nausea, gastrointestinal disturbances) |
|---|
- Agranulocytosis and neutropenia have been reported
- Routine monitoring of blood cell counts is recommended during handling
- Hepatotoxicity potential necessitates appropriate precautions to minimize exposure
Deferiprone 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.
Deferiprone (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.
Deferiprone API manufacturers & distributors
Compare qualified Deferiprone API suppliers worldwide. We currently have 5 companies offering Deferiprone 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 |
|---|---|---|---|---|---|
| Cipla | Producer | India | India | CoA, GMP, WC | 164 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
When sending a request, specify which Deferiprone 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 Deferiprone 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.
