Acriflavine manufacturers

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acriflavine + benzalkonium chloride

Cream 0.1 % + 0.025 % - 25 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Malaysia
GMP approvals
WHO
Manufacturer #39009

Founded in 1979, this Malaysian pharmaceutical company brings over four decades of experience producing Rx generics, OTC consumer health products, and biosimilars. Three GMP-certified facilities supply solid, liquid, and injectable dosage forms spanning cardiovascular, diabetes, and anti-infective therapy areas. Distributes across Southeast Asia and select international markets.

Manufacturer usually replies in 3 business days

acriflavine

Cutaneous solution 0.2 % - 1000 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #28191

This company is a pharmaceutical manufacturer with over three decades of experience established in 1992. They specialize in producing sterile ophthalmic products and non-sterile dermatological products, including ointments, creams, lotions, emulsions, gels, and medicated shampoos. Their key therapy areas focus on eye health and skin conditions. They offer a diverse range of dosage forms to cater to various patient needs. The company boasts several GMP certifications, including US FDA cGMP, WHO-GMP, ISO 13485:2016, ISO 9001:2015, Health-Canada, and PIC/S-Malaysia, demonstrating their commitment to quality and international standards. Their products are distributed across numerous countries globally, primarily in the EU and North America. They also hold product patents for several of their formulations.

acriflavine

Emulsion 0.1 % - 1000 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #28191

This company is a pharmaceutical manufacturer with over three decades of experience established in 1992. They specialize in producing sterile ophthalmic products and non-sterile dermatological products, including ointments, creams, lotions, emulsions, gels, and medicated shampoos. Their key therapy areas focus on eye health and skin conditions. They offer a diverse range of dosage forms to cater to various patient needs. The company boasts several GMP certifications, including US FDA cGMP, WHO-GMP, ISO 13485:2016, ISO 9001:2015, Health-Canada, and PIC/S-Malaysia, demonstrating their commitment to quality and international standards. Their products are distributed across numerous countries globally, primarily in the EU and North America. They also hold product patents for several of their formulations.

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About acriflavine

Acriflavine manufacturers today mainly supply veterinary and laboratory markets. In the EU, Aquarium Münster Pahlsmeier and Tetra hold authorisations for acriflavine-containing fish medicines. Acriflavine (INN acriflavinium chloride) is an acridine dye and topical antiseptic, developed by Paul Ehrlich in 1912. It was widely used during the First World War, and is now studied as an HIF-1 inhibitor in cancer research. Pharmaceutical and veterinary companies can source acriflavine API and finished products through supply or out-licensing.

Acriflavine key facts

Property Acriflavine
INN Acriflavinium chloride
Chemical description Mixture of 3,6-diamino-10-methylacridinium chloride and 3,6-diaminoacridine (proflavine)
Molecular formula / weight C14H14ClN3 / 259.7 g/mol (acriflavinium chloride component)
CAS number 8048-52-0 (acriflavine); 69235-50-3 (acriflavinium chloride mixture)
ATC code D08AA03 (antiseptic); R02AA13 (throat preparation); QG01AC90 (veterinary)
Drug class Acridine-derivative antiseptic
Brand names (veterinary, EU) Faunamor, Dessamor (Italy); TetraMedica FungiStop plus
Originator Paul Ehrlich (Germany), 1912
Dosage forms Concentrate or dip solution for ornamental fish; topical antiseptic solutions; API powder
Indications External fungal and bacterial infections of ornamental fish (EU veterinary); historically, wound antiseptic and throat preparations
EU veterinary approvals Italy, 22 February 2002 (Faunamor, Dessamor); Austria (Faunamor concentrate)
Research use HIF-1 inhibitor (Johns Hopkins, 2009); fluorescent stain for RNA
Control status Schedule 5 or 7 poison in Australia

Acriflavine manufacturers and licensing history

Acriflavine was developed in 1912 by Paul Ehrlich. During the First World War it was used as a topical antiseptic and against sleeping sickness. Its human use declined after penicillin was introduced.

Today, most authorised acriflavine products in the EU are veterinary medicines for ornamental fish. Aquarium Münster Pahlsmeier holds authorisations for Faunamor and Dessamor in Italy and Faunamor in Austria. Tetra markets TetraMedica FungiStop plus, which combines acriflavinium chloride with ethacridine, methylene blue and copper sulfate.

Acriflavine API is also sold as a laboratory reagent. Buyers should confirm pharmaceutical-grade GMP production, the proflavine-to-acriflavinium ratio and the impurity profile before choosing a supply partner.

Acriflavine dosage forms and dossier types

Acriflavine is mainly supplied as veterinary dip or concentrate solutions for ornamental fish, often in combination products. Human topical and throat preparations exist under ATC codes D08AA03 and R02AA13, but authorised human products are now rare.

Form Strengths Typical dossier Notes
Acriflavine fish dip / concentrate (combination) 0.3–2.0 mg/ml acriflavinium chloride EU veterinary dossier (Art. 12(3) full or Art. 13a well-established use) Ornamental fish; non-prescription
Acriflavine topical antiseptic solution Per national MA National dossier Historical human use; few current authorisations
Acriflavine API Bulk DMF / supplier documentation Mixture with proflavine; also sold as reagent
Target market Dossier format Key requirement
European Union (veterinary) EU veterinary dossier Ornamental fish only; pet-animal exemptions in some states
Australia National Schedule 5 or 7 poison controls
Other markets National Check whether human or veterinary use is authorised

Acriflavine regulatory and patent status

Acriflavine is an off-patent substance with more than a century of use. In the EU, current authorisations are veterinary products for ornamental fish. These include Faunamor and Dessamor in Italy, authorised on 22 February 2002, and Faunamor concentrate in Austria. Dessamor was authorised as a well-established-use application.

Acriflavine is listed under WHO ATC codes D08AA03 and R02AA13, but human products are now uncommon. In Australia, acriflavine is a Schedule 5 or Schedule 7 poison, depending on use.

Acriflavine mechanism of action and therapeutic use

Acriflavine intercalates into nucleic acids, which inhibits bacterial and viral replication. It is used topically as an antiseptic and in water treatments for external fungal infections of ornamental fish. In research, acriflavine binds HIF-1 alpha and blocks HIF-1 dimerisation, which reduced tumour growth and blood vessel formation in animal models. These cancer uses are not approved.

Acriflavine licensing and sourcing

Acriflavine suppliers and licensing partners typically offer API supply, finished veterinary products or dossier out-licensing. Buyers usually compare GMP status, product grade (pharmaceutical, veterinary or reagent), dossier format and territory availability. Current offers and supplier contacts are listed among the acriflavine manufacturers on Pipelinepharma.

Frequently asked questions about acriflavine

Who are the main acriflavine manufacturers?
In the EU, Aquarium Münster Pahlsmeier and Tetra hold authorisations for acriflavine-containing fish medicines. Acriflavine API is also produced by fine-chemical and reagent suppliers. Buyers should confirm which suppliers produce pharmaceutical-grade material.

Is acriflavine approved for human use?
Acriflavine has WHO ATC codes for human antiseptic (D08AA03) and throat (R02AA13) use, but authorised human products are now rare. Most current EU authorisations are veterinary products for ornamental fish.

What is the difference between acriflavine and proflavine?
Acriflavine is usually a mixture of acriflavinium chloride (3,6-diamino-10-methylacridinium chloride) and proflavine (3,6-diaminoacridine). Proflavine is a separate acridine antiseptic.

Is an acriflavine veterinary dossier available for licensing?
Acriflavine veterinary dossiers exist for ornamental-fish products in the EU, including full and well-established-use applications. Most are combination products with methylene blue, malachite green or ethacridine.

Is acriflavine a controlled substance?
Acriflavine is not a narcotic, but it is a Schedule 5 or Schedule 7 poison in Australia. Buyers should check local chemical and poison regulations before import.

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