Digitalis – the source for a life-saving API

Digitalis (commonly known as Foxglove) is a native Central European plant. You can find it mainly in forests during summer time. Digitalis was first recorded in the year 1542 by Leonard Fuchs.

This plant can also be found in many home gardens due to the beautiful flowering. But take care if children are around: 2-3 dried leaves can lead to death if eaten. 

This toxicological effect is exploited for the API Digoxin, which is extracted from digitalis. Digoxin, first discovered in 1930, is a powerful heart glycoside that strengthens the heart muscle to combat congestive heart failure and atrial fibrillation. One commonly known drug product brand is Lanoxin®. Digoxin is on the World Health Organization's List of Essential Medicines.
The Digitalis plant used for the extraction of Digoxin has been specially modified to provide a high yield of Digoxin. This plant does not have the typical digitalis blossom.

Transo-Pharm offers Digoxin from the Indian manufacturer, Alkaloids Corporation. They obtain Digitalis from a Dutch and a German grower and perform the extraction in Pune, South-East of Mumbai.

Key attributes are:

• Alkaloids produces Digoxin for more than 14 years
• One of the largest Digoxin production facilities worldwide
• FDA & EDQM inspected site
• Equipment: mono purpose extraction block, mono purpose finishing block (from crude to final API)
• Micronization step - including PSD analytics - is done in-house
• Installed capacity for up to 800 kg p.a.
• Production process is chloroform free
• Micronized material is very stable; does not require cold chain shipping & cold storage

 
Let’s circle back to the main subject of this article, Digitalis: Alkaloids always keeps 2 years stock of Digitalis in order to have a buffer just in case mother-nature causes a bad crop…