Allylestrenol manufacturers

About allylestrenol

Allylestrenol manufacturers include Gedeon Richter (Turinal), Dexa Medica (Pregnolin) and many producers in India and China. Allylestrenol is an oral progestogen used for threatened and recurrent miscarriage and to prevent premature labour. It was originally developed by Organon as Gestanin. It remains available in some European countries and much of Asia, but not in the US or Canada. Pharmaceutical companies can source allylestrenol 5 mg tablets and API through out-licensing, supply or technology transfer.

Allylestrenol key facts

Allylestrenol manufacturers and licensing history

Allylestrenol was developed by Organon and sold as Gestanin. Gedeon Richter of Hungary markets it as Turinal, which is widely sold in Central and Eastern Europe, Russia and Asia.

Allylestrenol is now made mainly in Asia. Dexa Medica sells Pregnolin in Indonesia, Chinese producers make allylestrenol tablets for the domestic market, and many Indian companies market 5 mg tablets. In Japan, a 25 mg tablet, Perselin, is used for benign prostatic hyperplasia.

Allylestrenol API is produced in India and China. Buyers should confirm GMP status, a DMF and the impurity profile before choosing a dossier partner.

Allylestrenol dosage forms and dossier types

Allylestrenol is approved as 5 mg tablets for pregnancy-related indications, and as 25 mg tablets in Japan for benign prostatic hyperplasia. Generic allylestrenol manufacturers most often develop 5 mg tablets.

Allylestrenol regulatory and patent status

Allylestrenol is off-patent. It is registered in a few European countries and widely in Asia, but not in the US or Canada. Current guidance says its use in miscarriage should be limited to cases of proven progesterone deficiency, so check local labels and treatment guidelines before filing.

Allylestrenol mechanism of action and therapeutic use

Allylestrenol acts like progesterone on the uterus. It supports the uterine lining and placental function, which helps maintain pregnancy. It is used for threatened and recurrent miscarriage and for threatened premature labour, usually at 5 mg one to three times daily. In Japan, higher doses are used for benign prostatic hyperplasia because of its antigonadotropic effects.

Allylestrenol licensing and sourcing

Allylestrenol 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 allylestrenol manufacturers on Pipelinepharma.

Frequently asked questions about allylestrenol

Who are the main allylestrenol manufacturers? Gedeon Richter makes Turinal, and Dexa Medica makes Pregnolin in Indonesia. Many Indian and Chinese companies also produce allylestrenol tablets and API.

Where is allylestrenol approved? Allylestrenol is available in some European countries, Russia, Japan and much of Asia. It is not approved in the US or Canada.

Is an allylestrenol dossier available for licensing? Yes. Allylestrenol 5 mg tablet dossiers are available in national CTD and ACTD formats, referencing Turinal.

What forms and strengths of allylestrenol are available? Allylestrenol is available as 5 mg tablets. Japan also has 25 mg tablets for benign prostatic hyperplasia.

Is allylestrenol still recommended for miscarriage? Current guidance limits its use in threatened or recurrent miscarriage to cases of proven progesterone deficiency.