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Erythropoietin | CAS No: 11096-26-7 | GMP-certified suppliers
A medication that treats anemia in chronic kidney disease, zidovudine‑treated HIV infection, and myelosuppressive chemotherapy while reducing transfusion needs in selected surgeries.
Therapeutic categories
Amino Acids, Peptides, and ProteinsAntianemic PreparationsBiological FactorsBlood and Blood Forming OrgansCarbohydratesColony-Stimulating Factors
Generic name
Erythropoietin
Molecule type
biotech
CAS number
11096-26-7
DrugBank ID
DB00016
Approval status
Approved drug
ATC code
B03XA01
Primary indications
- Indicated in adult and paediatric patients for the:
- Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis
- Treatment of anemia due to zidovudine in patients with HIV-infection
- Treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy
Product Snapshot
- Erythropoietin is an injectable recombinant biologic supplied mainly as solutions or lyophilized powder for parenteral use
- It is used for anemia associated with chronic kidney disease, myelosuppressive chemotherapy, HIV‑related zidovudine therapy, and for reducing transfusion needs in selected surgical settings
- It is approved in major regulated markets including the US, EU, and Canada
Clinical Overview
Erythropoietin (CAS 11096-26-7) is an endogenous renal glycoprotein hormone that regulates erythropoiesis by supporting the proliferation and maturation of erythroid progenitor cells. Recombinant epoetin alfa, a 165‑amino‑acid form produced in mammalian cell culture, is used clinically to correct anemia in chronic kidney disease, zidovudine‑treated HIV infection, myelosuppressive chemotherapy, and selected surgical settings to reduce transfusion requirements.
Epoetin alfa restores deficient erythropoietin activity by engaging the erythropoietin receptor on erythroid precursors. Ligand binding induces receptor conformational change and activates JAK2, leading to downstream phosphorylation of STAT5 and other signaling proteins. STAT5 dimerization and nuclear translocation drive transcription of genes promoting erythroblast survival and differentiation, including anti‑apoptotic pathways such as Bcl‑x. Additional JAK2‑dependent activation of Shc, PI3K, and phospholipase C‑γ1 contributes to erythroid cell proliferation and survival.
Pharmacodynamically, reticulocyte counts typically rise within about 10 days of treatment, with hemoglobin, hematocrit, and red cell mass increasing over 2 to 6 weeks. Responses vary by dose, and in hemodialysis patients, doses above approximately 300 Units/kg three times weekly do not produce enhanced biological effect.
Epoetin alfa has an approximate molecular weight of 30.4 kDa and shares the amino acid sequence and biological activity of endogenous erythropoietin. Intravenous and subcutaneous administration are both used clinically. Absorption, distribution, and elimination parameters vary with route, disease state, and formulation; systemic clearance largely reflects receptor‑mediated uptake and catabolism.
Safety considerations include risks of hypertension, thromboembolic events, excessive hemoglobin rise, and pure red cell aplasia. Dose adjustments are guided by hemoglobin trends, and iron status must be monitored. Biosimilars such as epoetin alfa‑epbx and epoetin zeta are approved in multiple regions and maintain comparable potency and quality to reference products.
For API procurement, sourcing should prioritize validated recombinant cell lines, consistent glycosylation profiles, robust control of host‑cell protein and DNA impurities, and comprehensive characterization to meet regional biologics quality standards.
Epoetin alfa restores deficient erythropoietin activity by engaging the erythropoietin receptor on erythroid precursors. Ligand binding induces receptor conformational change and activates JAK2, leading to downstream phosphorylation of STAT5 and other signaling proteins. STAT5 dimerization and nuclear translocation drive transcription of genes promoting erythroblast survival and differentiation, including anti‑apoptotic pathways such as Bcl‑x. Additional JAK2‑dependent activation of Shc, PI3K, and phospholipase C‑γ1 contributes to erythroid cell proliferation and survival.
Pharmacodynamically, reticulocyte counts typically rise within about 10 days of treatment, with hemoglobin, hematocrit, and red cell mass increasing over 2 to 6 weeks. Responses vary by dose, and in hemodialysis patients, doses above approximately 300 Units/kg three times weekly do not produce enhanced biological effect.
Epoetin alfa has an approximate molecular weight of 30.4 kDa and shares the amino acid sequence and biological activity of endogenous erythropoietin. Intravenous and subcutaneous administration are both used clinically. Absorption, distribution, and elimination parameters vary with route, disease state, and formulation; systemic clearance largely reflects receptor‑mediated uptake and catabolism.
Safety considerations include risks of hypertension, thromboembolic events, excessive hemoglobin rise, and pure red cell aplasia. Dose adjustments are guided by hemoglobin trends, and iron status must be monitored. Biosimilars such as epoetin alfa‑epbx and epoetin zeta are approved in multiple regions and maintain comparable potency and quality to reference products.
For API procurement, sourcing should prioritize validated recombinant cell lines, consistent glycosylation profiles, robust control of host‑cell protein and DNA impurities, and comprehensive characterization to meet regional biologics quality standards.
Identification & chemistry
| Generic name | Erythropoietin |
|---|---|
| Molecule type | Biotech |
| CAS | 11096-26-7 |
| UNII | 64FS3BFH5W |
| DrugBank ID | DB00016 |
Pharmacology
| Summary | Epoetin alfa is an exogenous erythropoietin analog that binds the erythropoietin receptor on erythroid progenitor cells to restore deficient signaling. Receptor engagement activates JAK2-mediated pathways, including STAT5, PI3K, and other effectors that promote erythroid cell survival, proliferation, and differentiation. These actions increase reticulocyte production and support normalization of erythrocyte mass in conditions with impaired endogenous erythropoietin activity. |
|---|---|
| Mechanism of action | Erythropoietin or exogenous epoetin alfa binds to the erythropoietin receptor (EPO-R) and activates intracellular signal transduction pathways . The affinity (Kd) of EPO for its receptor on human cells is ∼100 to 200 pM . Upon binding to EPO-R on the surface of erythroid progenitor cells, a conformational change is induced which brings EPO-R-associated Janus family tyrosine protein kinase 2 (JAK2) molecules into close proximity. JAK2 molecules are subsequently activated via phosphorylation, then phosphorylate tyrosine residues in the cytoplasmic domain of the EPO-R that serve as docking sites for Src homology 2-domain-containing intracellular signaling proteins . The signalling proteins include STAT5 that once phosphorylated by JAK2, dissociates from the EPO-R, dimerizes, and translocates to the nucleus where they serve as transcription factors to activate target genes involved in cell division or differentiation, including the apoptosis inhibitor Bcl-x . The inhibition of apoptosis by the EPO-activated JAK2/STAT5/Bcl-x pathway is critical in erythroid differentiation. Via JAK2-mediated tyrosine phosphorylation, erythropoietin and epoetin alfa also activates other intracellular proteins involved in erythroid cell proliferation and survival, such as Shc , phosphatidylinositol 3-kinase (PI3K), and phospholipase C-γ1 . |
| Pharmacodynamics | Erythropoietin and epoetin alfa are involved in the regulation of erythrocyte differentiation and the maintenance of a physiological level of circulating erythrocyte mass. It is reported to increase the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks . Depending on the dose administered, the rate of hemoglobin increase may vary. In patients receiving hemodialysis, a greater biologic response is not observed at doses exceeding 300 Units/kg 3 times weekly . Epoetin alfa serves to restore erythropoietin deficiency in pathological and other clinical conditions where normal production of erythropoietin is impaired or compromised. In anemic patients with chronic renal failure (CRF), administration with epoetin alfa stimulated erythropoiesis by increasing the reticulocyte count within 10 days, followed by increases in the red cell count, hemoglobin, and hematocrit, usually within 2 to 6 weeks [FDA Label]. Epoetin alfa was shown to be effective in increasing hematocrit in zidovudine-treated HIV-infected patients and anemic cancer patients undergoing chemotherapy [FDA Label]. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Erythropoietin receptor | Humans | agonist |
ADME / PK
| Absorption | The time to reach peak concentration is slower via the subcutaneous route than the intravenous route which ranges from 20 to 25 hours, and the peak is always well below the peak achieved using the intravenous route (5–10% of those seen with IV administration).The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenously administered product and is approximately 20-40%. **Adult and paediatric patients with CRF:** Following subcutaneous administration, the peak plasma levels are achieved within 5 to 24 hours [FDA Label]. **Cancer patients receiving cyclic chemotherapy:** The average time to reach peak plasma concentration was approximately 13.3 ± 12.4 hours after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing. The Cmax is expected be 3- to 7- fold higher and the Tmax is expected to be 2- to 3-fold longer in patients receiving a 40,000 Units SC weekly dosing regimen [FDA Label]. |
|---|---|
| Half-life | **Healthy volunteers:** The half life is approximately 4 hours in healthy volunteers receiving an intravenous injection . A half-life of approximately 6 hours has been reported in children . **Adult and paediatric patients with CRF:** The elimination half life following intravenous administration ranges from 4 to 13 hours, which is about 20% longer in CRF patients than that in healthy subjects. The half life is reported to be similar between adult patients receiving or not receiving dialysis [FDA Label]. **Cancer patients receiving cyclic chemotherapy:** Following subcutaneous administration, the average half life is 40 hours with range of 16 to 67 hours [FDA Label]. |
| Protein binding | No information of serum protein binding available. |
| Metabolism | Binding of erythropoietin and epoetin alfa to EPO-R leads to cellular internalization, which involves the degradation of the ligand. Erythropoietin and epoetin alfa may also be degraded by the reticuloendothelial scavenging pathway or lymphatic system . |
| Route of elimination | Erythropoietin and epoetin alfa are cleared via uptake and degradation via the EPO-R-expressing cells, and may also involve other cellular pathways in the interstitium, probably via cells in the reticuloendothelial scavenging pathway or lymphatic system . Only a small amount of unchanged epoetin alfa is found in the urine . |
| Volume of distribution | In healthy volunteers, the volume of distribution of intravenous epoetin alfa was generally similar to the plasma volume (range of 40–63.80 mL/kg), indicating limited extravascular distribution . |
| Clearance | **Healthy volunteers: ** In male volunteers receiving intravenous epoetin alfa, the total body clearance was approximately 8.12 ± 1.00 mL/h/kg . **Cancer patients receiving cyclic chemotherapy:** The average clearance was approximately 20.2 ± 15.9 mL/h/kg after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing [FDA Label]. The patients receiving a 40,000 Units SC weekly dosing regimen display a lower clearance (9.2 ± 4.7 mL/h/kg) [FDA Label]. |
Formulation & handling
- Recombinant glycoprotein biologic requiring parenteral administration (IV or SC) due to degradation in the GI tract.
- Cold‑chain handling is required; the protein is sensitive to agitation, heat, and freeze–thaw cycles.
- Formulations use aqueous solutions or lyophilized powder; avoid vigorous mixing to maintain structural integrity and activity.
Regulatory status
| Lifecycle | The API’s Canadian patent expired in 2014, and with established availability across the EU, US, and Canada, the product is in a mature, post‑exclusivity phase. Market dynamics are consistent with a well‑established generic environment. |
|---|
| Markets | EU, US, Canada |
|---|
Supply Chain
| Supply chain summary | Erythropoietin is supplied by several pharmaceutical manufacturers and packagers, with the originator role historically associated with companies marketing recombinant erythropoietin in major regulated markets. Branded products are established across the EU, US, and Canada. The listed Canadian patent expired in 2014, indicating that generic and biosimilar competition is already present or well‑established. |
|---|
Safety
| Toxicity | Overdose from epoetin alfa include signs and symptoms associated with an excessive and/or rapid increase in hemoglobin concentration, including cardiovascular events. Patients with suspected or known overdose should be monitored closely for cardiovascular events and hematologic abnormalities. Polycythemia should be managed acutely with phlebotomy, as clinically indicated. Following resolution of the overdose, reintroduction of epoetin alfa therapy should be accompanied by close monitoring for evidence of rapid increases in hemoglobin concentration (>1 gm/dL per 14 days). In patients with an excessive hematopoietic response, reduce the dose in accordance with the recommendations described in the drug label [FDA Label]. |
|---|
High Level Warnings:
- Rapid hemoglobin elevations from excessive exposure can precipitate cardiovascular events and other hematologic disturbances
- Compounds should be handled with controls that minimize risk of accidental high‑dose administration during development or manufacturing
- Excessive erythropoietic activity and polycythemia have been observed in overdose scenarios
Erythropoietin is a type of Erythropoietic growth factors
Erythropoietic growth factors belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically designed to stimulate the production of red blood cells in the body. These growth factors play a crucial role in the treatment of various medical conditions associated with reduced red blood cell production, such as anemia caused by chronic kidney disease, cancer, or certain types of chemotherapy.
The primary erythropoietic growth factor used in pharmaceutical formulations is recombinant human erythropoietin (rhEPO). This synthetic version of the naturally occurring hormone erythropoietin is produced using biotechnology processes, ensuring high purity and potency. RhEPO acts by binding to specific receptors on bone marrow cells, thereby promoting the production and maturation of red blood cells.
The use of erythropoietic growth factors has significantly improved the management of anemia-related conditions. By increasing red blood cell count, these pharmaceutical APIs help enhance oxygen-carrying capacity, leading to improved energy levels and reduced fatigue in patients. Additionally, they have the potential to reduce the need for blood transfusions, which can be associated with certain risks and complications.
When formulating medications containing erythropoietic growth factors, stringent quality control measures are employed to ensure product safety and efficacy. These APIs are typically formulated into injectable formulations to allow for precise dosing and rapid absorption.
In conclusion, erythropoietic growth factors, particularly recombinant human erythropoietin, are vital pharmaceutical APIs used to stimulate red blood cell production in various medical conditions. Their use has revolutionized the management of anemia-related disorders and improved the quality of life for many patients.
Erythropoietin (Erythropoietic growth factors), classified under Hematopoietic Agents
Hematopoietic agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the treatment of various blood disorders and diseases. These agents stimulate the production, maturation, and function of blood cells, particularly those involved in the process of hematopoiesis, which is the formation of new blood cells.
One of the commonly used hematopoietic agents is erythropoietin, a glycoprotein hormone that regulates red blood cell production. It is employed in the treatment of anemia associated with chronic kidney disease, cancer chemotherapy, and certain other conditions. Another important hematopoietic agent is granulocyte colony-stimulating factor (G-CSF), which stimulates the production of white blood cells known as neutrophils. G-CSF is used to prevent infections in patients undergoing chemotherapy and to enhance the recovery of blood cell counts after bone marrow transplantation.
Thrombopoietin receptor agonists are another class of hematopoietic agents that promote the production of platelets, essential for blood clotting. These agents find applications in the management of thrombocytopenia, a condition characterized by low platelet counts.
Hematopoietic agents are typically administered through injections or infusions, and their dosage and frequency vary depending on the specific indication and patient's response. While these agents provide critical therapeutic benefits, their use requires careful monitoring to ensure optimal efficacy and safety.
In conclusion, hematopoietic agents are vital pharmaceutical APIs used to stimulate the production of blood cells and treat various blood disorders. Their use significantly improves patients' quality of life and plays a crucial role in managing hematological conditions.
Erythropoietin API manufacturers & distributors
Compare qualified Erythropoietin API suppliers worldwide. We currently have 3 companies offering Erythropoietin API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 229 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Lek Pharma | Producer | Slovenia | Slovenia | CoA, GMP | 32 products |
When sending a request, specify which Erythropoietin 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 Erythropoietin 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 Erythropoietin API
Sourcing
What matters most when sourcing GMP-grade Erythropoietin?
Key considerations include confirming GMP compliance and alignment with regulatory expectations in the EU, US, and Canada. It is also important to verify that the manufacturer has experience supplying recombinant Erythropoietin in these regulated markets. Given the expired Canadian patent and the presence of biosimilars, assessing product comparability and supply reliability is essential.
Which documents are typically required when sourcing Erythropoietin API?
Request the core API documentation set: GMP (3 companies), CoA (3 companies), USDMF (2 companies), MSDS (2 companies), BSE/TSE (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Erythropoietin API?
Known or reported manufacturers for Erythropoietin: Apino Pharma Co., Ltd., AXXO GmbH. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Erythropoietin 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 Erythropoietin manufacturers?
Audit reports may be requested for Erythropoietin: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Erythropoietin API on Pharmaoffer?
Reported supplier count for Erythropoietin: 3 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Erythropoietin API?
Production countries reported for Erythropoietin: China (1 producer), Slovenia (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Erythropoietin usually hold?
Common certifications for Erythropoietin suppliers: GMP (3 companies), CoA (3 companies), USDMF (2 companies), MSDS (2 companies), BSE/TSE (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Erythropoietin (CAS 11096-26-7) used for?
Erythropoietin is used to treat anemia associated with chronic kidney disease, myelosuppressive chemotherapy, zidovudine‑treated HIV infection, and selected surgical settings to reduce transfusion requirements. It restores deficient Erythropoietin activity by activating Erythropoietin receptors and JAK2/STAT5 signaling, promoting proliferation and maturation of erythroid progenitor cells.
Which therapeutic class does Erythropoietin fall into?
Erythropoietin belongs to the following therapeutic categories: Amino Acids, Peptides, and Proteins, Antianemic Preparations, Biological Factors, Blood and Blood Forming Organs, Carbohydrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Erythropoietin mainly prescribed for?
The primary indications for Erythropoietin: Indicated in adult and paediatric patients for the:, Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis, Treatment of anemia due to zidovudine in patients with HIV-infection, Treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Erythropoietin work?
Erythropoietin or exogenous epoetin alfa binds to the Erythropoietin receptor (EPO-R) and activates intracellular signal transduction pathways . The affinity (Kd) of EPO for its receptor on human cells is ∼100 to 200 pM . Upon binding to EPO-R on the surface of erythroid progenitor cells, a conformational change is induced which brings EPO-R-associated Janus family tyrosine protein kinase 2 (JAK2) molecules into close proximity. JAK2 molecules are subsequently activated via phosphorylation, then phosphorylate tyrosine residues in the cytoplasmic domain of the EPO-R that serve as docking sites for Src homology 2-domain-containing intracellular signaling proteins . The signalling proteins include STAT5 that once phosphorylated by JAK2, dissociates from the EPO-R, dimerizes, and translocates to the nucleus where they serve as transcription factors to activate target genes involved in cell division or differentiation, including the apoptosis inhibitor Bcl-x . The inhibition of apoptosis by the EPO-activated JAK2/STAT5/Bcl-x pathway is critical in erythroid differentiation. Via JAK2-mediated tyrosine phosphorylation, Erythropoietin and epoetin alfa also activates other intracellular proteins involved in erythroid cell proliferation and survival, such as Shc , phosphatidylinositol 3-kinase (PI3K), and phospholipase C-γ1 .
What should someone know about the safety or toxicity profile of Erythropoietin?
Erythropoietin can cause rapid hemoglobin increases, which may trigger hypertension, thromboembolic events, or other cardiovascular complications. Excessive exposure may lead to excessive erythropoietic activity, polycythemia, and hematologic disturbances, and rare cases of pure red cell aplasia have been associated with its use. Careful dose adjustment based on hemoglobin trends and appropriate handling during development and manufacturing help reduce the risk of accidental high‑dose administration.
What are important formulation and handling considerations for Erythropoietin as an API?
Erythropoietin is a recombinant glycoprotein that requires parenteral formulation, typically as an aqueous solution or lyophilized powder, because it is degraded in the gastrointestinal tract. It must be handled under cold‑chain conditions and protected from heat, agitation, and freeze–thaw cycles to maintain structural integrity. Reconstitution or dilution should avoid vigorous mixing to prevent protein denaturation. These measures support stability and preserve biological activity during manufacturing and administration.
Is Erythropoietin a biotech?
Erythropoietin is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Erythropoietin?
Oral Erythropoietin is not viable because the protein is degraded in the gastrointestinal tract, so stability concerns focus on its parenteral formulations. The molecule is sensitive to heat, freezing, and agitation, requiring cold‑chain storage and gentle handling. Both aqueous and lyophilized formulations must be protected from temperature excursions and vigorous mixing to maintain structural integrity and activity.
Regulatory
Where is Erythropoietin approved or in use globally?
Erythropoietin is reported as approved in the following major regions: EU, US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Erythropoietin right now?
Erythropoietin is regulated and approved for use in the EU, US, and Canada. Patent protection for Erythropoietin products is product‑specific and varies by manufacturer and formulation, and multiple versions coexist under differing intellectual property frameworks in these regions.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Erythropoietin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Erythropoietin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Erythropoietin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Erythropoietin: 274 verified transactions across 46 suppliers and 76 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Erythropoietin?
Market report availability for Erythropoietin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
