Aspirin manufacturers

About aspirin

Aspirin manufacturers include the originator Bayer and hundreds of generic producers worldwide, with most API made in China and Europe. Aspirin (acetylsalicylic acid) is one of the oldest and most widely used medicines. At higher doses, it relieves pain, fever and inflammation. At low doses, it prevents blood clots and is used to prevent heart attacks and strokes. Pharmaceutical companies can source aspirin tablets, gastro-resistant and effervescent forms, and API through out-licensing, supply or technology transfer. Dossiers are available in EU CTD and US ANDA or OTC formats.

Aspirin key facts

Aspirin manufacturers and licensing history

Bayer chemists made a pure, stable form of acetylsalicylic acid in 1897, and Bayer registered the Aspirin trademark in 1899. In many countries, "aspirin" later became a generic name, while Bayer keeps the trademark in others.

Today, aspirin is made by hundreds of companies worldwide. Most acetylsalicylic acid API is produced in China, with Bayer and other European producers also supplying large volumes. Finished products range from simple tablets to gastro-resistant, effervescent and combination products, such as fixed-dose combinations with clopidogrel or statins.

Buyers should confirm GMP status, a CEP or DMF, salicylic acid impurity limits and moisture protection in packaging before choosing a dossier partner.

Aspirin dosage forms and dossier types

Aspirin is approved in many forms. Generic aspirin manufacturers most often develop low-dose gastro-resistant tablets for heart protection and standard tablets for pain.

Aspirin regulatory and patent status

Aspirin is off-patent and available worldwide. It is on the WHO Model List of Essential Medicines. Guidance on low-dose aspirin for primary prevention has tightened in recent years, and it is now mainly recommended for secondary prevention in people with heart disease or previous stroke. Labels warn against use in children and teenagers because of Reye's syndrome.

Aspirin mechanism of action and therapeutic use

Aspirin irreversibly blocks cyclooxygenase (COX) enzymes. At higher doses, this reduces prostaglandins and relieves pain, fever and inflammation. At low doses, it stops platelets producing thromboxane A2 for their whole lifespan, which reduces blood clotting. Aspirin is used for pain and fever, and at low doses to prevent heart attacks and strokes.

Aspirin licensing and sourcing

Aspirin suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, US FDA or WHO GMP), dossier format, API source and territory availability. Current offers and supplier contacts are listed among the aspirin manufacturers on Pipelinepharma.

Frequently asked questions about aspirin

Who are the main aspirin manufacturers? Bayer is the originator. Hundreds of generic manufacturers make aspirin worldwide, and most API is produced in China and Europe.

Is an aspirin EU CTD dossier available for licensing? Yes. Aspirin low-dose gastro-resistant and analgesic tablet dossiers in EU CTD format are widely available.

What forms and strengths of aspirin are available? Aspirin is available as 75–100 mg low-dose tablets, 300–500 mg analgesic tablets, gastro-resistant, effervescent and chewable tablets, and combinations.

What is the difference between aspirin and acetylsalicylic acid? They are the same substance. Acetylsalicylic acid is the INN, and Aspirin is Bayer's trademark, which became a generic name in many countries.

Can children take aspirin? Aspirin is generally not used in children and teenagers because of the risk of Reye's syndrome, except under medical supervision for specific conditions.