This CTD dossier owner and manufacturer, operating for over four decades in South Asia, manufactures and markets a diverse range of products. Their portfolio includes OTC and prescription drugs in various dosage forms such as creams, lotions, tablets, syrups, and injections. Their key product categories include dermatological products, dental care, ear and nasal drops, analgesics, and ayurvedic remedies. They emphasize quality, timely delivery, and cost-efficiency in their operations. While the company does not explicitly mention therapy areas, their product offerings suggest a focus on areas like dermatology, pain management, and oral health. They have a strong track record of success in the region.
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.