Ammonium glycyrrhizate manufacturers

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ammonium glycyrrhizate

Tablets, enteric coated 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
EU GMP
Manufacturer #39894

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About ammonium glycyrrhizate

Ammonium glycyrrhizate manufacturers include liquorice extract producers such as MAFCO and many Chinese producers, plus Minophagen Pharmaceutical in Japan, which uses it in Stronger Neo-Minophagen C. Ammonium glycyrrhizate is the ammonium salt of glycyrrhizin, the main active compound in liquorice root. It is used in liver medicines in Japan and China, as an anti-inflammatory in skin products, and as a sweetener and flavour. Pharmaceutical companies can source ammonium glycyrrhizate API and finished products through supply or out-licensing.

Ammonium glycyrrhizate key facts

Property

Ammonium glycyrrhizate

Names

Ammonium glycyrrhizate; monoammonium glycyrrhizinate (MAG)

Source

Liquorice root (Glycyrrhiza glabra, G. uralensis, G. inflata)

Molecular formula / weight

C42H65NO16 / 840.0 g/mol

CAS number

53956-04-0 (monoammonium salt)

Pharmacopoeia

Ph. Eur. monograph (ammonium glycyrrhizate)

Drug class

Hepatoprotective; anti-inflammatory; flavour and sweetener

Key medicines

Stronger Neo-Minophagen C (injection, Japan); Glycyron (tablets, Japan); compound glycyrrhizin injections and tablets (China)

SNMC composition

2.65 mg/ml monoammonium glycyrrhizinate (2 mg/ml glycyrrhizin), with glycine and cysteine

Indications (Japan, China)

Chronic liver disease (improvement of liver function); some allergic and skin conditions

Other uses

Anti-irritant in cosmetics; sweetener and flavour (e.g. Magnasweet)

Key safety risk

Pseudoaldosteronism: high blood pressure, low potassium, oedema

Ammonium glycyrrhizate manufacturers and licensing history

Glycyrrhizin has been used in Japanese medicine for decades. Minophagen Pharmaceutical's Stronger Neo-Minophagen C (SNMC), an intravenous injection, contains monoammonium glycyrrhizinate with glycine and cysteine. It is used for chronic liver disease, and Glycyron tablets provide an oral form.

In China, compound glycyrrhizin injections and tablets based on monoammonium glycyrrhizinate are widely used for liver disease. Many Chinese companies make both the API and the finished products.

Ammonium glycyrrhizate is also a common cosmetic ingredient and a flavour enhancer. MAFCO is a major supplier of liquorice derivatives, including Magnasweet.

Buyers should confirm the grade (pharmaceutical, cosmetic or food), compliance with the Ph. Eur. monograph and GMP status before choosing a supplier.

Ammonium glycyrrhizate dosage forms and dossier types

Ammonium glycyrrhizate is supplied as injections and tablets for liver disease, as an ingredient in topical products and as bulk API.

Form

Strengths

Typical dossier

Notes

Compound glycyrrhizin injection

E.g. 2 mg/ml glycyrrhizin (with glycine and cysteine)

Japan / China national dossier

Reference SNMC; liver disease

Compound glycyrrhizin tablets

Per national MA

Japan / China national dossier

Reference Glycyron

Ammonium glycyrrhizate API

Bulk

Ph. Eur.; DMF

Pharmaceutical, cosmetic or food grade

Target market

Dossier format

Key requirement

Japan

Japanese dossier

Reference SNMC or Glycyron

China

NMPA (CTD-based)

Many local generics

European Union

Ph. Eur. API; cosmetic or food use

No approved liver medicine; used as excipient and in cosmetics

Other Asian markets

National CTD

Check local registration

Ammonium glycyrrhizate regulatory and patent status

Ammonium glycyrrhizate is off-patent and has a Ph. Eur. monograph. Glycyrrhizin injections and tablets are approved medicines in Japan and China. In the EU and US, ammonium glycyrrhizate is used mainly in cosmetics, as an excipient and as a flavour. Labels warn about pseudoaldosteronism, especially at high doses or with diuretics and corticosteroids.

Ammonium glycyrrhizate mechanism of action and therapeutic use

Glycyrrhizin has anti-inflammatory and immune-modulating effects and helps protect liver cells. In Japan and China, it is used to improve liver function in chronic liver disease, including viral hepatitis. On the skin, it is used to soothe irritation. High doses can cause sodium retention and potassium loss, leading to high blood pressure.

Ammonium glycyrrhizate licensing and sourcing

Ammonium glycyrrhizate suppliers and licensing partners typically offer API supply, finished-product supply or dossier out-licensing. Buyers usually compare GMP status, product grade, pharmacopoeial compliance and territory availability. Current offers and supplier contacts are listed among the ammonium glycyrrhizate manufacturers on Pipelinepharma.

Frequently asked questions about ammonium glycyrrhizate

Who are the main ammonium glycyrrhizate manufacturers? Minophagen Pharmaceutical makes SNMC and Glycyron in Japan. Many Chinese companies make compound glycyrrhizin products and API, and MAFCO supplies liquorice derivatives worldwide.

What is the difference between ammonium glycyrrhizate and glycyrrhizin? Glycyrrhizin (glycyrrhizic acid) is the active compound in liquorice root. Ammonium glycyrrhizate is its ammonium salt, which is more stable and easier to formulate.

What is ammonium glycyrrhizate used for? Ammonium glycyrrhizate is used in liver medicines in Japan and China, as an anti-inflammatory in skin products, and as a sweetener and flavour.

Is ammonium glycyrrhizate approved in the EU? Ammonium glycyrrhizate has a Ph. Eur. monograph and is used in cosmetics and as an excipient. No glycyrrhizin liver medicine is approved in the EU.

What are the safety risks of ammonium glycyrrhizate? At high doses, ammonium glycyrrhizate can cause pseudoaldosteronism, with high blood pressure, low potassium and fluid retention.

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