About aminocaproic acid
Aminocaproic acid manufacturers include Epic Pharma (Amicar), Hikma, and US generic makers such as Vitruvias, Leading Pharma, Ajenat, Somerset and Sunny, plus producers in China, Japan and Russia. Aminocaproic acid is an antifibrinolytic that helps stop bleeding by preventing blood clots from breaking down. Pharmaceutical companies can source aminocaproic acid tablets, oral solution and injection through out-licensing, supply or technology transfer. Dossiers are available in US ANDA and CTD formats.
Aminocaproic acid key facts
|
Property |
Aminocaproic acid |
|---|---|
|
INN |
Aminocaproic acid (epsilon-aminocaproic acid) |
|
Chemical name |
6-aminohexanoic acid |
|
Molecular formula / weight |
C6H13NO2 / 131.2 g/mol |
|
CAS number |
60-32-2 |
|
ATC code |
B02AA01 |
|
Drug class |
Antifibrinolytic |
|
Brand name |
Amicar (US) |
|
US NDA |
NDA 015197 (Amicar) |
|
Dosage forms and strengths |
Tablets 500 mg and 1,000 mg; oral solution 250 mg/ml; injection 250 mg/ml |
|
Indications |
To enhance haemostasis when fibrinolysis contributes to bleeding |
|
Typical dose |
4–5 g in the first hour, then 1–1.25 g per hour; maximum 30 g per day |
|
US generics |
Several, including oral solution approvals in 2018, 2021 and 2022 |
|
Patent status |
Off-patent |
Aminocaproic acid manufacturers and licensing history
Aminocaproic acid has been used since the 1960s and is sold in the US as Amicar. Epic Pharma holds the Amicar tablet and oral solution products, and Hikma supplies injection.
US generics are made by several companies, including Vitruvias and Leading Pharma for tablets. Generic oral solutions were approved for Sunny (2018), Ajenat (2021) and Somerset (2022). Aminocaproic acid is also widely used in China, Japan and Russia.
Aminocaproic acid API is simple to make and widely available. Buyers should confirm GMP status, a US DMF and the impurity profile before choosing a dossier partner.
Aminocaproic acid dosage forms and dossier types
Aminocaproic acid is approved as tablets, oral solution and injection. Generic aminocaproic acid manufacturers most often develop tablets and oral solution.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Aminocaproic acid tablets |
500 mg, 1,000 mg |
US ANDA; CTD |
Reference Amicar |
|
Aminocaproic acid oral solution |
250 mg/ml |
US ANDA |
Also used as mouthwash for dental bleeding |
|
Aminocaproic acid injection |
250 mg/ml |
US ANDA; CTD |
Hospital use; contains benzyl alcohol |
|
Aminocaproic acid API |
Bulk |
US DMF |
Widely available |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
ANDA (eCTD) |
Reference Amicar; bioequivalence |
|
European Union |
EU CTD |
Check national reference products; tranexamic acid is more common |
|
China, Russia, Asia |
National CTD |
Widely registered |
Aminocaproic acid regulatory and patent status
Aminocaproic acid is long off-patent. Amicar remains the US reference product, and several generic tablets and oral solutions are approved. In much of Europe, tranexamic acid is used more often, so check whether a reference product is authorised in each target country.
Aminocaproic acid mechanism of action and therapeutic use
Aminocaproic acid blocks plasminogen activators and, to a lesser extent, plasmin itself. This stops fibrin clots from breaking down too quickly. It is used when excessive fibrinolysis contributes to bleeding, such as after heart surgery or in some bleeding disorders. It should not be used when there is active intravascular clotting.
Aminocaproic acid licensing and sourcing
Aminocaproic acid 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 and readiness, API source and territory availability. Current offers and supplier contacts are listed among the aminocaproic acid manufacturers on Pipelinepharma.
Frequently asked questions about aminocaproic acid
Who are the main aminocaproic acid manufacturers? Epic Pharma holds Amicar, and Hikma supplies injection in the US. Generic makers include Vitruvias, Leading Pharma, Ajenat, Somerset and Sunny.
Is there a generic version of aminocaproic acid? Yes. Generic aminocaproic acid tablets and oral solution are approved in the US, with oral solution approvals in 2018, 2021 and 2022.
What is the difference between aminocaproic acid and tranexamic acid? Both are antifibrinolytics. Tranexamic acid is about ten times more potent and is more widely used in Europe.
What forms and strengths of aminocaproic acid are available? Aminocaproic acid is available as 500 mg and 1,000 mg tablets, 250 mg/ml oral solution and 250 mg/ml injection.
Is an aminocaproic acid dossier available for licensing? Yes. Aminocaproic acid tablet, oral solution and injection dossiers are available in US ANDA and CTD formats.
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