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amorolfine

Nail lacquer 5%

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
Argentina
Manufacturer #16463
The company was formed in the 2000s. as the result of a great business effort, with quality, prestige, and ethics at the service of the medical body as standards. It is one of the largest diversified health care companies in the world, with a presence in more than 160 countries and made up of more than 107,000 employees dedicated to making people not only live longer but better. They offer a wide range of solutions for health care, with a portfolio of products belonging to the Ophthalmology and Respiratory Lines.

Manufacturer usually replies in 3 days

amorolfine

Nail lacquer 5g/100ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
Argentina
Manufacturer #16192
A pharmaceutical manufacturer based in LATAM that is active in dermatology, urology, and respiratory for 20+ years.

Manufacturer usually replies in 3 days

Amorolfine

Amorolfine is a morpholine antifungal drug. It cures Onychomycosis, a fungal infection of the toe and fingernails. It’s actions inhibits enzymes, depleting ergosterol and causes ignosterol to accumulate in the fungal cytoplasmic cell membranes. Amorolfine is commonly sold as a topical solution. Efficacy studies conducted back in the 90s suggested that the medicine was highly effective in curing toenail onychomycosis with nearly 70% cure rate; complete cure rates three months to six months after stopping treatment was also high at 50%. However in the acute case, Systemic treatments may be considered more effective.

A fungal nail infection spreads from a fungal skin infection causing nails to thicken and discolour, and cause pain. While the regular course of treatment is antifungal tablets, however, sometimes applying an antifungal lacquer directly to the nail is more suitable if the infection is at the tip of the fingernail or toenail.

Amorolfine is marketed as Curanail, Loceryl, Locetar, and Odenil amongst other brand names. It is manufactured in several countries around the world as generic formulation. Johnson & Johnson Consumer Products, Inc. filed the first patent and received approval for medical use in 1994. However, Galderma Research and Development SNC, which it has held since 2004, own the current patent. In between, several other companies have filed their individual patents. Amorolfine is approved for sale as an over-the-counter topical solution in Australia, Brazil, Russia, Germany and the UK, and by prescription in other countries. The FDA does not approve Amorolfine in the United States or Canada. However, it can be ordered by mail from other countries.

Forms and Dosage:

Amorolfine is available as a topical solution. It is a nail lacquer with 5% concentration. The patient is recommended to apply the nail lacquer once each week to the affected area. The treatment takes between 6 to 12 months before it can completely cure the infection.

The price of Amorolfine

The price of one fluid ounce of nail lacquer is around US$36 in the developed world. However, this medicine is significantly cheaper when prepared by local generic medicine makers. A OTC version of the same medicine costs as low as US$8 in India.

How does Amorolfine work?

Amorolfine is a morpholine derivative. Its actions inhibit ergosterol biosynthesis in the fungal cell membrane. Ergosterol is a sterol of cell membranes in fungi and protozoa. It serves works similar to cholesterol serves in animal cells. Fungi and protozoa cannot survive without ergosterol. Ergosterol is a provitamin form of vitamin D2 which is formed in our body through exposure to sunlight. This medicine alters the membrane sterol content leading to increased membrane permeability eventually disrupting key fungal metabolic processes.

Finding Amorolfine Manufacturers and Suppliers

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