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Country of origin : Spain

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2 products found

terbinafine

Tablets, film coated 250 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref: Lamisil®
Manufacturer #252
This company is a leading player in the pharmaceutical industry, boasting decades of experience in research, development, and manufacturing. They specialize in the production of a wide range of pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) for both human and veterinary use. Their product portfolio spans multiple therapeutic areas, including but not limited to, oncology, cardiology, and other essential therapeutic categories. They offer a comprehensive range of services, including contract manufacturing (CMO) and the production of over-the-counter (OTC) products. The company holds EU and US GMP approvals for its production lines, ensuring adherence to rigorous quality standards. Their production lines encompass various dosage forms, including solids, liquids, and injectables. Their global presence extends across Europe and North America, with a network of 10 manufacturing facilities. They have a strong commitment to research and development, with dedicated teams focusing on innovative solutions and advancements in the pharmaceutical field.

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Terbinafine is an antifungal medication pityriasis versicolor, fungal nail infections, tinea capitis, tinea corporis, tinea cruris, tinea pedis, and cutaneous candidiasis. Terbinafine manufacturers produce medications with it as the standalone ingredient, as well as use it in combination drug formulations along with ingredients such as mometasone and urea. Suppliers of terbinafine market it in the form of 125mg and 250mg oral tablets as well as 10mg/g topical creams. The developer and earliest manufacturer of terbinafine was Novartis, who first introduced it into the market under the trade name Lamisil in Europe in 1991, and the U.S. in 1996. Lamisil is currently available in over 70 countries worldwide, including but not limited to Australia, Brazil, Russia, South Africa, Thailand, and many more geographical markets. What is more, following the expiry of the manufacturer’s patent in 2007, other producers and suppliers launched their formulations of the drug into the market. Terbinafine is included in the World Health Organization’s list of Essential Medicines that contains the most important medications recommended for a basic health system. And it is a widely prescribed drug, with over 1 million prescriptions being registered yearly in the U.S. alone. The global terbinafine market is fragmented, with multiple pharmaceutical companies, from small local manufacturers to large multinational industry players marketing both generic and trade name terbinafine formulations. Among the largest manufacturers and suppliers of terbinafine are well-known names such as Novartis, GlaxoSmithKline, Gedeon Richter, Sun Pharmaceuticals, Teva, Pfizer, and Mylan. Buyers are advised that online sellers may attempt to market fraudulent versions of the generic drug, whereas Pipeline Pharma, through its pre-auditing and quality control procedures ensures that only verified terbinafine manufacturers and wholesalers enter our online marketplace, offering you a risk-free B2B pharmaceutical sales platform. Costs per 28 (250mg) tablets of terbinafine range from 25 EUR to 30 EUR, whereas 15g (10mg/g) of terbinafine topical cream can cost anywhere from 4,00 EUR to 11,00 EUR.

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