Albumin tannate manufacturers

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albumin tannate

Tablets 500 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #16168
It focuses on manufacturing drugs from herbal source materials. They are one of Europe's largest herbal medicine manufacturers. They have been introducing contemporary herbal remedies to the market for over 75 years, integrating natural medicine successes with the most cutting-edge medication production methods.

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About albumin tannate

Albumin tannate manufacturers include Medice in Germany (Tannalbin tablets) and several Japanese producers of Japanese Pharmacopoeia albumin tannate powder. Albumin tannate (tannin albuminate) is a heat-treated compound of protein and tannic acid that slowly releases tannin in the gut. It is used as an astringent antidiarrhoeal. Pharmaceutical companies can source albumin tannate tablets, powder and API through out-licensing, supply or technology transfer.

Albumin tannate key facts

Property

Albumin tannate

Common names

Albumin tannate; tannin albuminate; tannic acid albumin

Chemical description

Protein (albumin) combined with tannic acid and hardened by heat

CAS number

9006-52-4

ATC code

A07XA01

Drug class

Antidiarrhoeal; intestinal astringent

Brand names

Tannalbin (Germany); Japanese Pharmacopoeia albumin tannate (several makers)

Dosage forms and strengths

Tablets 500 mg (Germany); oral powder (Japan)

Protein source

Egg albumin in German Tannalbin; Japanese products are contraindicated in milk allergy

Indications

Diarrhoea (non-specific)

Germany

Tannalbin 500 mg tablets, Medice, authorised 15 September 2003; non-prescription

Japan

Japanese Pharmacopoeia monograph; products marketed since 1953

Japanese API master files

Nikko Pharmaceutical; Yashiro Pharmaceutical

Albumin tannate manufacturers and licensing history

Albumin tannate is an old antidiarrhoeal with no single originator. It is made by heating tannic acid with protein at 110–120 °C for several hours, which gives a compound that releases tannin slowly in the intestine.

In Germany, Medice markets Tannalbin 500 mg tablets, made with egg albumin. The current authorisation dates from 15 September 2003, and the product is sold freely without prescription.

In Japan, albumin tannate is listed in the Japanese Pharmacopoeia and sold as powder by several companies, with products on the market since 1953. Japanese products are contraindicated in people with milk allergy. Nikko Pharmaceutical and Yashiro Pharmaceutical hold Japanese master files for the API.

Buyers should confirm the protein source (egg or milk), GMP status and pharmacopoeial standard before choosing a supplier.

Albumin tannate dosage forms and dossier types

Albumin tannate is supplied as 500 mg tablets in Germany and as oral powder in Japan.

Form

Strengths

Typical dossier

Notes

Albumin tannate tablets

500 mg

EU national dossier

Reference Tannalbin; non-prescription

Albumin tannate oral powder

Bulk powder for dispensing

Japanese dossier

Japanese Pharmacopoeia standard

Albumin tannate API

Bulk

Japanese master file

Protein source must be declared

Target market

Dossier format

Key requirement

Germany, EU

National CTD

Reference Tannalbin; egg allergy labelling

Japan

Japanese CTD

Japanese Pharmacopoeia; milk allergy contraindication

Other markets

National

Check local antidiarrhoeal rules

Albumin tannate regulatory and patent status

Albumin tannate is off-patent and long established. It is classified under ATC code A07XA01. In Germany, Tannalbin is a non-prescription medicine. In Japan, albumin tannate is a pharmacopoeial product, sold by several companies.

Albumin tannate mechanism of action and therapeutic use

Albumin tannate passes through the stomach and slowly releases tannin in the intestine. Tannin binds proteins on the gut lining, which has an astringent effect and reduces secretion. It does not produce measurable tannin levels in the blood. Albumin tannate is used for non-specific diarrhoea. It should be taken several hours apart from iron preparations, which tannin can inactivate.

Albumin tannate licensing and sourcing

Albumin tannate suppliers and licensing partners typically offer finished-product supply, dossier out-licensing or API supply. Buyers usually compare GMP status, protein source, pharmacopoeial standard and territory availability. Current offers and supplier contacts are listed among the albumin tannate manufacturers on Pipelinepharma.

Frequently asked questions about albumin tannate

Who are the main albumin tannate manufacturers? Medice makes Tannalbin tablets in Germany. In Japan, several companies sell Japanese Pharmacopoeia albumin tannate powder, and Nikko Pharmaceutical and Yashiro Pharmaceutical hold API master files.

Is albumin tannate a prescription medicine? In Germany, Tannalbin tablets are sold without prescription. Status varies by country.

Is albumin tannate safe for people with allergies? It depends on the product. German Tannalbin is made with egg albumin, and Japanese products are contraindicated in milk allergy. Labels should state the protein source.

What forms and strengths of albumin tannate are available? Albumin tannate is available as 500 mg tablets in Germany and as oral powder in Japan.

Does albumin tannate interact with other medicines? Yes. Albumin tannate can make iron preparations less effective, so the two should be taken several hours apart.

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