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Evolocumab | CAS No: 1256937-27-5 | GMP-certified suppliers
A medication that supports cardiovascular risk reduction and lowers LDL‑cholesterol in adults and pediatric patients with primary hyperlipidemia or familial hypercholesterolemia.
Therapeutic categories
Amino Acids, Peptides, and ProteinsAntibodiesAntibodies, MonoclonalAnticholesteremic AgentsAntimetabolitesBlood Proteins
Generic name
Evolocumab
Molecule type
biotech
CAS number
1256937-27-5
DrugBank ID
DB09303
Approval status
Approved drug
ATC code
C10AX13
Primary indications
- Evolocumab is indicated in adult patients with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
- It is also indicated as an adjunct to diet, alone or in combination with other hypolipidemic treatments, in adults with primary hyperlipidemia (and in pediatric patients ≥10 years old with heterozygous familial hypercholesterolemia) to reduce LDL-C
- In addition, it is indicated adjunctly to other hypolipidemic treatments in patients ≥10 years old with homozygous familiar hypercholesterolemia to reduce LDL-C
Product Snapshot
- Injectable monoclonal antibody supplied as a subcutaneous solution for parenteral administration
- Used for LDL‑C reduction in primary hyperlipidemia, heterozygous and homozygous familial hypercholesterolemia, and for cardiovascular risk reduction
- Approved in major regulated markets including the US, Canada, and the EU
Clinical Overview
Evolocumab (CAS 1256937-27-5) is a fully human IgG2 monoclonal antibody used for LDL‑cholesterol reduction in patients requiring intensive lipid management. It is indicated for adults with established atherosclerotic cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization. It is also approved as adjunct therapy to diet, with or without other lipid‑lowering agents, for primary hyperlipidemia in adults and in pediatric patients aged 10 years or older with heterozygous familial hypercholesterolemia. In patients aged 10 years or older with homozygous familial hypercholesterolemia, it is used in combination with other lipid‑lowering treatments to reduce LDL‑C.
Evolocumab acts by selectively binding circulating PCSK9, a hepatic serine protease that targets LDL receptors for lysosomal degradation. By preventing PCSK9 interaction with LDL receptors, the antibody promotes receptor recycling to the hepatocyte surface, thereby increasing LDL‑C clearance. It binds both wild‑type PCSK9 and gain‑of‑function variants such as D374Y, which are associated with markedly elevated LDL‑C in familial hypercholesterolemia.
Absorption occurs following subcutaneous administration, with bioavailability typical for IgG monoclonal antibodies. Distribution is largely confined to the vascular and interstitial compartments. Metabolism proceeds through nonspecific IgG catabolic pathways, generating small peptides and amino acids. Clearance is target‑mediated and decreases as PCSK9 levels are saturated. The elimination half‑life aligns with that of endogenous IgG subclasses.
Safety considerations include injection‑site reactions, nasopharyngitis, influenza‑like symptoms, and rare hypersensitivity events. As a protein therapeutic, immunogenicity is possible, though neutralizing antibody development has been uncommon in clinical use. No LDL‑lowering ceiling effect is observed when used with maximally tolerated statins.
Common brand references include products marketed globally under the name Repatha for subcutaneous self‑administration.
For API procurement, reliable sourcing requires control of cell line lineage, consistency of glycosylation and tertiary structure, validated viral clearance steps, and adherence to ICH guidelines for biologics manufacturing and quality documentation.
Evolocumab acts by selectively binding circulating PCSK9, a hepatic serine protease that targets LDL receptors for lysosomal degradation. By preventing PCSK9 interaction with LDL receptors, the antibody promotes receptor recycling to the hepatocyte surface, thereby increasing LDL‑C clearance. It binds both wild‑type PCSK9 and gain‑of‑function variants such as D374Y, which are associated with markedly elevated LDL‑C in familial hypercholesterolemia.
Absorption occurs following subcutaneous administration, with bioavailability typical for IgG monoclonal antibodies. Distribution is largely confined to the vascular and interstitial compartments. Metabolism proceeds through nonspecific IgG catabolic pathways, generating small peptides and amino acids. Clearance is target‑mediated and decreases as PCSK9 levels are saturated. The elimination half‑life aligns with that of endogenous IgG subclasses.
Safety considerations include injection‑site reactions, nasopharyngitis, influenza‑like symptoms, and rare hypersensitivity events. As a protein therapeutic, immunogenicity is possible, though neutralizing antibody development has been uncommon in clinical use. No LDL‑lowering ceiling effect is observed when used with maximally tolerated statins.
Common brand references include products marketed globally under the name Repatha for subcutaneous self‑administration.
For API procurement, reliable sourcing requires control of cell line lineage, consistency of glycosylation and tertiary structure, validated viral clearance steps, and adherence to ICH guidelines for biologics manufacturing and quality documentation.
Identification & chemistry
| Generic name | Evolocumab |
|---|---|
| Molecule type | Biotech |
| CAS | 1256937-27-5 |
| UNII | LKC0U3A8NJ |
| DrugBank ID | DB09303 |
Pharmacology
| Summary | Evolocumab is a monoclonal antibody that binds PCSK9, a hepatic protease that promotes lysosomal degradation of LDL receptors. By blocking PCSK9–receptor interactions, it preserves LDL receptor recycling to the cell surface and enhances cellular clearance of circulating LDL‑cholesterol. This results in sustained reduction of plasma LDL‑cholesterol across both normal and gain‑of‑function PCSK9 variants. |
|---|---|
| Mechanism of action | Evolocumab is a human IgG monoclonal antibody which targets PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is a serine protease produced by the liver which binds LDL receptors and creates a complex to be targeted for lysosomal degradation. LDL receptors typically bind LDL-cholesterol ("bad" cholesterol) for cellular reuptake, therefore the formation of these complexes with PCSK9 inhibits LDL receptor recycling to the cell surface, resulting in decreased cellular reuptake of LDL-C and increased levels of free LDL-C in the plasma. Individuals with familial hypercholesterolemia often may have "gain of function" mutations in the PCSK9 molecules in their body, resulting in increased LDL-C plasma levels and a consequent cardiovascular risk. Evolocumab is able to bind both the normal PCSK9 and the "gain of function" mutant, D374Y. The exact mechanism of the binding has not been published, however the precursor molecule, mAb1, is indicative of the interaction. The mAb1 molecule binds on the catalytic site of PCSK9 next to the binding site for the LDL receptor and creates hydrogen bonds and hydrophobic interactions, resulting in the steric inhibition of binding between PCSK9 and the LDL receptor. Because the formation of complexes between LDL receptor and PCSK9 are prevented, the internalized LDL receptors are less likely to be degrated by lysosomes and may recycle to the surface of the cell to serve their function of removing LDL from the blood. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Proprotein convertase subtilisin/kexin type 9 | Humans | inhibitor |
ADME / PK
| Absorption | Total bioavailability from subcutaneous injection was 82% in cynomolgus monkeys. |
|---|---|
| Clearance | Evolocumab showed non-linear, dose-dependent clearance in healthy volunteers; clearance decreased with increasing dose. |
Formulation & handling
- Recombinant monoclonal antibody supplied as an aqueous solution for subcutaneous administration; requires cold‑chain storage and protection from agitation to maintain structural integrity.
- High protein concentration formulations (up to 140 mg/mL) may exhibit elevated viscosity, influencing device selection and injection force considerations.
- Formulation stressors such as heat, freezing, or vigorous shaking can cause aggregation, necessitating controlled handling during transport and compounding steps.
Regulatory status
| Lifecycle | With key patent protections expired or nearing expiry, the API is broadly established in the US, Canada, and EU. Market presence across these regions indicates a mature lifecycle with limited remaining exclusivity. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Evolocumab is supplied by a single originator company that manufactures the reference biologic used across major regulated markets, including the United States, Canada, and the European Union. The branded product has broad global availability, with distribution centered in these regions. Patent protection for the molecule remains in force in key markets, indicating that biosimilar competition is limited at present but may increase as expiries approach in the coming years. |
|---|
Evolocumab is a type of Lipid-lowering agents
Lipid-lowering agents are a category of pharmaceutical active ingredients (APIs) that are widely used in the treatment of hyperlipidemia, a condition characterized by elevated levels of lipids (such as cholesterol and triglycerides) in the blood. These agents play a crucial role in managing lipid abnormalities and reducing the risk of cardiovascular diseases.
One of the most commonly prescribed lipid-lowering agents is statins. Statins work by inhibiting an enzyme called HMG-CoA reductase, which is responsible for the production of cholesterol in the liver. By blocking this enzyme, statins effectively lower cholesterol levels in the bloodstream.
Another class of lipid-lowering agents is fibric acid derivatives, which primarily target triglyceride levels. These agents activate a nuclear receptor known as PPAR-alpha, which regulates lipid metabolism. By activating PPAR-alpha, fibric acid derivatives enhance the breakdown of triglycerides and increase the elimination of fatty acids from the bloodstream.
Additionally, bile acid sequestrants are often used as lipid-lowering agents. These agents bind to bile acids in the intestine, preventing their reabsorption. As a result, the liver utilizes more cholesterol to produce new bile acids, leading to a decrease in circulating cholesterol levels.
Lipid-lowering agents are available in various formulations, including tablets, capsules, and suspensions, allowing for convenient administration. They are usually prescribed alongside lifestyle modifications, such as dietary changes and regular exercise, to optimize the management of hyperlipidemia.
It is important to note that the use of lipid-lowering agents should be under the supervision of a healthcare professional, as they may have potential side effects and interactions with other medications. Proper monitoring of lipid levels and regular follow-up visits are essential for ensuring the effectiveness and safety of these pharmaceutical agents.
Evolocumab API manufacturers & distributors
Compare qualified Evolocumab API suppliers worldwide. We currently have 1 companies offering Evolocumab 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF, WHO-GMP | 229 products |
When sending a request, specify which Evolocumab 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 Evolocumab 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 Evolocumab API
Sourcing
What matters most when sourcing GMP-grade Evolocumab?
Key considerations include confirming that the material is manufactured under GMP and compliant with US, Canadian, and EU regulatory requirements. Because Evolocumab is supplied by a single originator, verifying authorized supply channels and documentation is essential. Patent protection in major markets limits alternative sources, so ensuring legitimate origin and full traceability is critical.
Which documents are typically required when sourcing Evolocumab API?
Request the core API documentation set: CoA (1 company), BSE/TSE (1 company), USDMF (1 company), WHO-GMP (1 company), GMP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Evolocumab API?
Known or reported manufacturers for Evolocumab: Apino Pharma Co., Ltd.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Evolocumab 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 Evolocumab manufacturers?
Audit reports may be requested for Evolocumab: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Evolocumab API on Pharmaoffer?
Reported supplier count for Evolocumab: 1 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Evolocumab API?
Production countries reported for Evolocumab: China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Evolocumab usually hold?
Common certifications for Evolocumab suppliers: CoA (1 company), BSE/TSE (1 company), USDMF (1 company), WHO-GMP (1 company), GMP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Evolocumab (CAS 1256937-27-5) used for?
Evolocumab is used to reduce elevated LDL‑cholesterol in patients who require intensive lipid lowering. It is indicated for adults with atherosclerotic cardiovascular disease to lower the risk of myocardial infarction, stroke, and coronary revascularization, and as adjunct therapy for primary hyperlipidemia in adults and in children aged 10 years or older with heterozygous familial hypercholesterolemia. It is also used with other lipid‑lowering treatments in patients aged 10 years or older with homozygous familial hypercholesterolemia.
Which therapeutic class does Evolocumab fall into?
Evolocumab belongs to the following therapeutic categories: Amino Acids, Peptides, and Proteins, Antibodies, Antibodies, Monoclonal, Anticholesteremic Agents, Antimetabolites. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Evolocumab mainly prescribed for?
The primary indications for Evolocumab: Evolocumab is indicated in adult patients with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization, It is also indicated as an adjunct to diet, alone or in combination with other hypolipidemic treatments, in adults with primary hyperlipidemia (and in pediatric patients ≥10 years old with heterozygous familial hypercholesterolemia) to reduce LDL-C, In addition, it is indicated adjunctly to other hypolipidemic treatments in patients ≥10 years old with homozygous familiar hypercholesterolemia to reduce LDL-C. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Evolocumab work?
Evolocumab is a human IgG monoclonal antibody which targets PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is a serine protease produced by the liver which binds LDL receptors and creates a complex to be targeted for lysosomal degradation. LDL receptors typically bind LDL-cholesterol ("bad" cholesterol) for cellular reuptake, therefore the formation of these complexes with PCSK9 inhibits LDL receptor recycling to the cell surface, resulting in decreased cellular reuptake of LDL-C and increased levels of free LDL-C in the plasma. Individuals with familial hypercholesterolemia often may have "gain of function" mutations in the PCSK9 molecules in their body, resulting in increased LDL-C plasma levels and a consequent cardiovascular risk. Evolocumab is able to bind both the normal PCSK9 and the "gain of function" mutant, D374Y. The exact mechanism of the binding has not been published, however the precursor molecule, mAb1, is indicative of the interaction. The mAb1 molecule binds on the catalytic site of PCSK9 next to the binding site for the LDL receptor and creates hydrogen bonds and hydrophobic interactions, resulting in the steric inhibition of binding between PCSK9 and the LDL receptor. Because the formation of complexes between LDL receptor and PCSK9 are prevented, the internalized LDL receptors are less likely to be degrated by lysosomes and may recycle to the surface of the cell to serve their function of removing LDL from the blood.
What should someone know about the safety or toxicity profile of Evolocumab?
Evolocumab is generally well tolerated, with injection‑site reactions, nasopharyngitis, and influenza‑like symptoms reported as common adverse effects. Rare hypersensitivity reactions can occur, and immunogenicity is possible, although neutralizing antibodies have been uncommon. As an IgG monoclonal antibody, it follows typical protein catabolic pathways and does not show unexpected organ‑specific toxicities in the provided context. Its safety profile is consistent with target‑mediated clearance and the pharmacology of PCSK9 inhibition.
What are important formulation and handling considerations for Evolocumab as an API?
Evolocumab is a recombinant monoclonal antibody formulated as an aqueous solution that requires cold‑chain storage and protection from agitation to preserve structural integrity. High‑concentration formulations can have increased viscosity, which affects injection device selection and required injection force. Heat, freezing, or vigorous shaking can induce aggregation, so controlled handling during transport and compounding is essential.
Is Evolocumab a biotech?
Evolocumab is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies.
Regulatory
Where is Evolocumab approved or in use globally?
Evolocumab is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Evolocumab right now?
Evolocumab is approved for use in the United States, Canada, and the European Union. In these regions, its ongoing availability is governed by standard regulatory requirements for biologic therapies. Patent protections follow jurisdiction‑specific frameworks that define the duration of market exclusivity and outline requirements for biosimilar entry.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Evolocumab procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Evolocumab. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Evolocumab included in the PRO Data Insights coverage?
PRO Data Insights coverage for Evolocumab: . Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Evolocumab?
Market report availability for Evolocumab: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
