anidulafungin
Powder for solution for infusion
100 mg
Manufacturer usually replies in 5 days
Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Storage +2 - +8 C
Manufacturer #1586
A pharmaceutical manufacturer based in the EU that has been selling its products in Europe, the Middle East, CIS, LATAM, and Asia for 10+ years.
The company's production lines are GMP-compliant.
Main dosage forms include solid, liquid, and injection.
The company prepares dossier in EU CTD format.
Manufacturer usually replies in 5 days
Anidulafungin
Anidulafungin is an antifungal medication used to treat fungal infections. It is mainly used to
cure infections in the blood, abdomen, or stomach, and esophagus.
It is effective in treating candidemia and other forms of candida infections, which occur in
intra-abdominal abscess, and peritonitis, aspergillus infections, and esophageal candidiasis,
and recommended for the treatment of or pharyngeal candidiasis. It is a semi-synthetic
lipopeptide synthesized while fermenting Aspergillus nidulans.
Anidulafungin is sold under the trade names Eraxis, Ecalta, and Andulfa amongst others. Due
to the common occurrence of these infections around the world, this medicine is
manufactured and supplied by companies around the world.
Vicuron Pharmaceuticals originally manufactured and submitted for FDA approval. Pfizer
acquired the drug upon its acquisition of Vicuron in the fall of 2005 and got FDA approval in,
2006.
Forms and Dosage:
Anidulafungin is a white to off-white powder. It is practically insoluble in water and slightly
soluble in ethanol. It is available as injection, lyophilized product for intravenous (IV)
infusion.
In the treatment of Candidemia, Candidal Peritonitis, Intra-Abdominal Abscess, the
recommended initial dose is 200 mg through an IV infusion, followed by 100 mg per day
from day 2. This medicine should be administered 14 days after the last positive culture.
In the treatment of Esophageal Candidiasis, the initial adult dose is 100 mg through an IV
infusion, followed by 50 mg per day, from day 2. This treatment has to be continued for at
least 2 weeks and at least for a week post-resolution of symptoms.
Off-label, Anidulafungin has also been used to treat Candida Auris, and based on the latest tests it
has been recommended by the CDC as initial therapy for the treatment of C Auris infections. In
the treatment of these infections, the initial adult dose is 200 mg and 100 mg from day2.
The cost of Anidulafungin
In the USA, the consumers have to pay around $103 for a supply of 1 powder for injection, of
50 mg quantity. In India, a100mg vials are sold at USD130 for 1 injection.
How does Anidulafungin work?
Anidulafungin is a cyclic lipopeptide echinocandin derivative. This enzyme is important for
fungal cell wall synthesis, which results in the final cell lysis and death. The active agent
works against Candida species and Aspergillus. It is different in that it inhibits glucan
synthase, but not mammalian cells. Overall resulting in inhibition of the formation of 1,3-β-
D-glucan, ultimately leading to osmotic instability and cell death.
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