About alpha-lipoic acid
Alpha-lipoic acid manufacturers include Viatris (Thioctacid, from Meda), Berlin-Chemie (Berlithion), Wörwag Pharma (espa-lipon), Aristo Pharma and many producers in India, China and Russia. Alpha-lipoic acid, also called thioctic acid, is an antioxidant used to treat the symptoms of diabetic polyneuropathy. It is a medicine in Germany, Eastern Europe, Russia and Asia, and a dietary supplement in the US. Pharmaceutical companies can source alpha-lipoic acid 600 mg tablets and injection through out-licensing, supply or technology transfer.
Alpha-lipoic acid key facts
|
Property |
Alpha-lipoic acid |
|---|---|
|
INN |
Thioctic acid |
|
Molecular formula / weight |
C8H14O2S2 / 206.3 g/mol |
|
CAS number |
1077-28-7 (racemic) |
|
ATC code |
A16AX01 |
|
Drug class |
Antioxidant; agent for diabetic neuropathy |
|
Brand names |
Thioctacid (Viatris), Berlithion (Berlin-Chemie), espa-lipon (Wörwag), Alpha-Lipon (Aristo), alpha-Vibolex, many others |
|
Dosage forms and strengths |
Film-coated tablets 300 mg and 600 mg (including high-release HR forms); solution for injection or infusion 600 mg |
|
Indication |
Sensory symptoms of diabetic polyneuropathy |
|
Typical dose |
600 mg once daily, 30 minutes before breakfast; IV for 2–4 weeks in severe cases |
|
Germany examples |
Thioctacid 600 HR, authorised 18 January 2001; Alpha-Lipon Aristo 600 mg infusion, 24 November 2003 |
|
Pharmacopoeia |
Ph. Eur. monograph (thioctic acid) |
|
Key safety warning |
Insulin autoimmune syndrome; check blood glucose at start of treatment |
|
US status |
Dietary supplement |
Alpha-lipoic acid manufacturers and licensing history
Alpha-lipoic acid was developed in Germany as a medicine for diabetic neuropathy. Thioctacid is the best-known brand. It was developed by Asta Medica, later marketed by Meda and now by Viatris. Thioctacid 600 HR tablets were authorised in Germany on 18 January 2001.
Many other companies sell alpha-lipoic acid. Berlin-Chemie sells Berlithion across Eastern Europe, Wörwag sells espa-lipon, and Aristo sells tablets and infusions. In Russia, local producers such as Biokhimik make 600 mg tablets. India, China, Turkey, Korea and Taiwan also have many brands.
Alpha-lipoic acid API is produced mainly in China and India. Buyers should confirm GMP status, compliance with the Ph. Eur. monograph and whether the API is racemic or R-lipoic acid before choosing a dossier partner.
Alpha-lipoic acid dosage forms and dossier types
Alpha-lipoic acid is approved as 300 mg and 600 mg tablets and as 600 mg injection or infusion. Generic alpha-lipoic acid manufacturers most often develop 600 mg tablets.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Alpha-lipoic acid film-coated tablets |
300 mg, 600 mg |
EU CTD (national); EAEU CTD |
Main form for licensing; reference Thioctacid |
|
Alpha-lipoic acid injection / infusion |
600 mg (e.g. 600 mg/24 ml or 600 mg/50 ml) |
EU CTD (national); EAEU CTD |
Hospital use; severe neuropathy |
|
Alpha-lipoic acid API |
Bulk |
DMF; Ph. Eur. |
Racemic form used in medicines |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
Germany, Central and Eastern Europe |
EU CTD (national) |
Reference Thioctacid |
|
Russia and EAEU |
EAEU CTD |
Many local generics |
|
Asia, Middle East |
ACTD / CTD |
Registered as a medicine in many countries |
|
United States |
Dietary supplement |
Not an approved drug |
Alpha-lipoic acid regulatory and patent status
Alpha-lipoic acid is off-patent and authorised nationally as a medicine in Germany, Austria, Eastern Europe, Russia and much of Asia. Labels warn about insulin autoimmune syndrome and about reduced effect of cisplatin when given together. In the US, it is sold only as a dietary supplement.
Alpha-lipoic acid mechanism of action and therapeutic use
Alpha-lipoic acid is a natural coenzyme in energy metabolism. It acts as an antioxidant, neutralising free radicals and restoring glutathione levels. In diabetic polyneuropathy, it is used to reduce burning, pain and numbness. Tablets are taken once daily on an empty stomach, and severe cases may start with 2–4 weeks of IV treatment.
Alpha-lipoic acid licensing and sourcing
Alpha-lipoic acid suppliers and licensing partners typically offer dossier out-licensing, finished-product supply or technology transfer. Buyers usually compare GMP status (EU GMP, WHO GMP), dossier format and readiness, API source and territory availability. Current offers and supplier contacts are listed among the alpha-lipoic acid manufacturers on Pipelinepharma.
Frequently asked questions about alpha-lipoic acid
Who are the main alpha-lipoic acid manufacturers? Viatris sells Thioctacid, Berlin-Chemie sells Berlithion, Wörwag sells espa-lipon and Aristo sells Alpha-Lipon. Many companies in Russia, India, China and Turkey also make alpha-lipoic acid medicines.
What is the difference between alpha-lipoic acid and thioctic acid? They are the same substance. Thioctic acid is the INN, and alpha-lipoic acid is the common name.
Is an alpha-lipoic acid dossier available for licensing? Yes. Alpha-lipoic acid 600 mg tablet and injection dossiers are available in EU CTD and EAEU formats, referencing Thioctacid.
What forms and strengths of alpha-lipoic acid are available? Alpha-lipoic acid is available as 300 mg and 600 mg tablets and as 600 mg injection or infusion.
Is alpha-lipoic acid approved in the US? No. In the US, alpha-lipoic acid is sold as a dietary supplement, not as an approved drug.
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