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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