anidulafungin Injection, lyophilized 100 mg

Dossier type
Dossier status
Ready to file
Country of origin
GMP approvals
PICS, Turkey
Available for
Licensing with supply, Distribution only
Reference Product : Eraxis/Ecalta
Manufacturer #2748
It is a privately held pharmaceutical company based in southeast Europe that was established in the 1990s to import and introduce pharmaceutical items into medicine. The company began by importing hemophilia and intensive care supplies, as well as immunoglobulin-containing items. To suit market demands, the company has added additional dermatological, cardiological, urological, and surgical goods to its portfolio since then. They now offer a diverse product line that includes not only prescription but also OTC, medical gadgets, and dermo-cosmetics.

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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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