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Alirocumab API Manufacturers & Suppliers

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China

Producer
Produced in  China
|

Employees: 10+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
BSE/TSE
|
CoA
|
WHO-GMP

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USDMF
BSE/TSE
CoA
WHO-GMP
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France

Producer
Produced in  France
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
CoA

All certificates

GMP
CoA
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Alirocumab | CAS No: 1245916-14-6 | GMP-certified suppliers

A medication that helps reduce cardiovascular event risk and lowers elevated LDL cholesterol in adults with established cardiovascular disease or primary hyperlipidemia.

Therapeutic categories

Amino Acids, Peptides, and ProteinsAntibodiesAntibodies, MonoclonalAnticholesteremic AgentsAntimetabolitesBlood Proteins
Generic name
Alirocumab
Molecule type
biotech
CAS number
1245916-14-6
DrugBank ID
DB09302
Approval status
Approved drug
ATC code
C10AX14

Primary indications

  • Alirocumab is an antibody eliciting proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor activity that is indicated for:
  • (i) use in reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease , and/or
  • (ii) use as an adjunct to diet or use alone or in combination with other lipid-lowering therapies (statins, ezetimibe, for example) for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C) levels in the body

Product Snapshot

  • Alirocumab is a subcutaneous injectable monoclonal antibody API
  • It is used for LDL‑C reduction in primary hyperlipidemia, including HeFH, and for cardiovascular risk reduction in established disease
  • It is approved in the US, Canada, and the EU

Clinical Overview

Alirocumab (CAS 1245916-14-6) is a fully human IgG1 monoclonal antibody approved for the management of dyslipidemia and cardiovascular risk reduction. It is indicated to lower the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. It is also used as an adjunct to diet, alone or in combination with other lipid‑lowering therapies, for primary hyperlipidemia including heterozygous familial hypercholesterolemia when additional LDL cholesterol reduction is required.

Alirocumab exerts its therapeutic activity through selective inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 normally binds hepatic LDL receptors and targets them for lysosomal degradation, limiting receptor recycling and reducing LDL cholesterol clearance. By binding circulating PCSK9, alirocumumab prevents this receptor loss, leading to increased hepatic LDL receptor availability and enhanced plasma LDL cholesterol uptake. The pharmacodynamic effect is a concentration‑dependent reduction in free PCSK9 and sustained LDL cholesterol lowering.

As a monoclonal antibody, alirocumab displays pharmacokinetic properties typical of large proteins, including limited volume of distribution and catabolic clearance through proteolytic pathways. Absorption after subcutaneous administration is gradual, and systemic exposure is influenced by target‑mediated drug disposition due to binding interactions with PCSK9. No hepatic or renal metabolism pathways are involved.

Safety considerations reflect its biologic nature. Hypersensitivity reactions, injection site reactions, and rare immunogenicity events have been observed. Long‑term safety monitoring has focused on potential effects of profound LDL cholesterol lowering, although no specific toxicity pattern has been consistently demonstrated in clinical trials.

Alirocumab is marketed in several regions, with Praluent being a commonly used brand. Formulations are supplied as injectable solutions for subcutaneous administration.

For API procurement, sourcing should prioritize suppliers with validated biologics manufacturing capability, robust control of cell culture and purification processes, and comprehensive analytical characterization to ensure product identity, potency, purity, and consistency across batches.

Identification & chemistry

Generic name Alirocumab
Molecule type Biotech
CAS 1245916-14-6
UNII PP0SHH6V16
DrugBank ID DB09302

Pharmacology

SummaryAlirocumab is a monoclonal antibody that binds to and inhibits PCSK9, preventing PCSK9‑mediated degradation of LDL receptors. This increases hepatic LDL receptor availability and enhances clearance of circulating LDL cholesterol. Its pharmacodynamic effect is characterized by concentration‑dependent reductions in free PCSK9.
Mechanism of actionAlirocumab is a fully human IgG1 monoclonal antibody that binds and inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme found to have "gain of function" mutations in autosomal dominant hypercholesterolemia. PCSK9 is secreted by the liver and typically binds to the LDL receptors in serum and marks them for lysosomal degradation. In result, the LDL receptors are not able to recycle to the plasma membrane, reducing their binding to LDL-C and therefore reducing the clearance of LDL-C from plasma. Therefore by inhibiting PCSK9's actions, alirocumab allows for more LDL-C reuptake by the liver and facilitates a higher rate of clearance. Lower LDL cholesterol concentrations are associated with a reduced risk of coronary heart disease.
PharmacodynamicsAlirocumab reduces levels of PCSK9 in a concentration-dependent manner.
Targets
TargetOrganismActions
Proprotein convertase subtilisin/kexin type 9Humansinhibitor

ADME / PK

AbsorptionFollowing subcutaneous (SC) administration, alirocumab is absorbed into the bloodstream and maximum concentrations are reached at a median time of 3-7 days. The absolute availability after SC administration was 85%.
Half-lifeIn monotherapy, the median half-life of alirocumab at steady state was 17–20 days in patients receiving alirocumab at SC doses of 75 or 150 mg every 2 weeks. As statin therapy increases the production of PCSK9, statin co-administration is thought to shorten alirocumab half-life; therefore the median apparent half-life of alirocumab was reduced to 12 days at equivalent alirocumab doses. However, this difference is not considered clinically significant and does not change dosing recommendations.
MetabolismAntibodies are generally metabolized by the reticuloendothelial system and degraded into small peptides and individual amino acids - therefore specific metabolism studies were not conducted. Alirocumab did not show evidence of affecting CYP 450 enzymes or transporter proteins in co-administration with statins.
Volume of distributionAlirocumab is mainly distributed through the circulatory system, with minimal extravascular distribution.

Formulation & handling

  • Alirocumab is a monoclonal antibody supplied as a ready‑to‑use aqueous solution for subcutaneous administration, requiring biologic‑appropriate excipients to maintain conformational stability.
  • The protein formulation is sensitive to agitation and freeze–thaw cycles, necessitating controlled cold‑chain storage and gentle handling during fill–finish.
  • As a parenteral biologic, it is not suitable for oral delivery due to enzymatic degradation and poor gastrointestinal absorption.

Regulatory status

LifecycleThe API is marketed in the US, Canada, and the EU, indicating broad commercialization across major regulated markets. With patent expiry expected to shift the product toward a post‑exclusivity phase, the lifecycle is moving into a mature stage characterized by increasing generic competition.
MarketsUS, Canada, EU
Supply Chain
Supply chain summaryAlirocumab is supplied by a small number of originator biologic manufacturers responsible for both development and commercial production. Branded products are established in the US, Canada, and EU, reflecting broad geographic distribution. Patent protection for this biologic remains in place in key markets, so biosimilar competition is expected only after upcoming expiries, with limited alternative suppliers currently active.

Good Manufacturing Practices

Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
 

Alirocumab is a type of PCSK9-inhibitors

PCSK9 inhibitors belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) and are widely used in the treatment of hypercholesterolemia, specifically for patients with familial hypercholesterolemia or those who are unable to achieve optimal cholesterol levels through traditional therapies.


PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein that plays a crucial role in regulating the number of low-density lipoprotein (LDL) receptors on the surface of liver cells. These receptors are responsible for removing LDL cholesterol from the bloodstream. Inhibiting the action of PCSK9 can lead to increased LDL receptor availability, resulting in enhanced LDL cholesterol clearance and lowered LDL cholesterol levels.

Pharmaceutical API subcategory PCSK9 inhibitors are designed to target PCSK9 and prevent it from binding to LDL receptors. This inhibition allows for increased recycling and preservation of LDL receptors on liver cells, leading to improved LDL cholesterol clearance and reduced LDL cholesterol levels in the blood.

PCSK9 inhibitors, such as evolocumab and alirocumab, are typically administered through subcutaneous injections. These drugs have demonstrated significant efficacy in reducing LDL cholesterol levels and have shown great promise in preventing cardiovascular events in high-risk patients.

The development of PCSK9 inhibitors represents a breakthrough in the management of hypercholesterolemia, particularly in patients who do not respond well to statin therapy or who require additional LDL cholesterol reduction. Ongoing research aims to optimize PCSK9 inhibitors' efficacy, safety, and dosing regimens to further enhance their clinical impact on cardiovascular health.


Alirocumab (PCSK9-inhibitors), classified under 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.



Alirocumab API manufacturers & distributors

Compare qualified Alirocumab API suppliers worldwide. We currently have 2 companies offering Alirocumab 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.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
China China BSE/TSE, CoA, USDMF, WHO-GMP229 products
Producer
France France CoA, GMP93 products

When sending a request, specify which Alirocumab 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 Alirocumab 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.

We show synonyms and CAS numbers for Alirocumab API to help you connect with the right supplier. However, a synonym or CAS number does not always mean it is exactly the same specification. Always confirm the final specs directly with the supplier before placing an order.

Frequently asked questions about Alirocumab API


Sourcing

What matters most when sourcing GMP-grade Alirocumab?
Key considerations include verifying compliance with GMP standards in the US, Canada, and EU to meet regulatory expectations across these markets. Because Alirocumab is produced by a small number of originator biologic manufacturers, confirming lawful sourcing and supply continuity is essential. Patent protection in major markets also requires attention to ensure procurement aligns with current exclusivity restrictions.
Which documents are typically required when sourcing Alirocumab API?
Request the core API documentation set: CoA (2 companies), GMP (1 company), BSE/TSE (1 company), USDMF (1 company), WHO-GMP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Alirocumab API?
Known or reported manufacturers for Alirocumab: Apino Pharma Co., Ltd.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Alirocumab 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 Alirocumab manufacturers?
Audit reports may be requested for Alirocumab: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Alirocumab API on Pharmaoffer?
Reported supplier count for Alirocumab: 2 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Alirocumab API?
Production countries reported for Alirocumab: China (1 producer), France (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Alirocumab usually hold?
Common certifications for Alirocumab suppliers: CoA (2 companies), GMP (1 company), BSE/TSE (1 company), USDMF (1 company), WHO-GMP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Alirocumab (CAS 1245916-14-6) used for?
Alirocumab is used to lower LDL cholesterol in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia, when additional LDL reduction is needed. It is also used to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
Which therapeutic class does Alirocumab fall into?
Alirocumab 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 Alirocumab mainly prescribed for?
The primary indications for Alirocumab: Alirocumab is an antibody eliciting proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor activity that is indicated for:, (i) use in reducing the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease , and/or, (ii) use as an adjunct to diet or use alone or in combination with other lipid-lowering therapies (statins, ezetimibe, for example) for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C) levels in the body. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Alirocumab work?
Alirocumab is a fully human IgG1 monoclonal antibody that binds and inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme found to have "gain of function" mutations in autosomal dominant hypercholesterolemia. PCSK9 is secreted by the liver and typically binds to the LDL receptors in serum and marks them for lysosomal degradation. In result, the LDL receptors are not able to recycle to the plasma membrane, reducing their binding to LDL-C and therefore reducing the clearance of LDL-C from plasma. Therefore by inhibiting PCSK9's actions, Alirocumab allows for more LDL-C reuptake by the liver and facilitates a higher rate of clearance. Lower LDL cholesterol concentrations are associated with a reduced risk of coronary heart disease.
What should someone know about the safety or toxicity profile of Alirocumab?
Alirocumab’s safety profile reflects its use as a biologic monoclonal antibody. Reported adverse effects include hypersensitivity reactions, injection‑site reactions, and infrequent immunogenicity. Clinical experience has not shown a consistent toxicity pattern related to LDL‑cholesterol lowering, but long‑term monitoring remains part of routine use.
What are important formulation and handling considerations for Alirocumab as an API?
Alirocumab is formulated as a ready‑to‑use aqueous solution for subcutaneous injection and requires excipients that maintain monoclonal antibody conformational stability. The protein is sensitive to agitation and freeze–thaw cycles, so cold‑chain storage and gentle handling during manufacturing and distribution are necessary. Because it is a parenteral biologic with poor gastrointestinal stability and absorption, it is not suitable for oral formulations. Its distribution is primarily intravascular, which supports formulation approaches that preserve systemic exposure after subcutaneous administration.
Is Alirocumab a biotech?
Alirocumab is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Alirocumab?
An oral formulation of Alirocumab is not feasible because the monoclonal antibody would undergo enzymatic degradation in the gastrointestinal tract and has poor absorption by this route. Its stability is maintained only in a controlled, aqueous formulation for subcutaneous use, which requires protection from agitation, freeze–thaw cycles, and temperature excursions.

Regulatory

Where is Alirocumab approved or in use globally?
Alirocumab 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 Alirocumab right now?
Alirocumab is regulated in major markets including the United States, Canada, and the European Union. Its development and use follow the established approval and oversight frameworks in these regions. Patent protection is generally managed under each region’s standard pharmaceutical patent systems, which govern exclusivity and generic entry.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Alirocumab procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Alirocumab. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Alirocumab included in the PRO Data Insights coverage?
PRO Data Insights coverage for Alirocumab: . Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Alirocumab?
Market report availability for Alirocumab: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.