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Country of origin : South-korea

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terbinafine + lidocaine + diphenhydramine hydrochloride + enoxolone

Gel 10 mg + 20 mg + 10 mg + 1 mg - 15 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
South Korea
Manufacturer #21263

​Established in 1959, this Manufacturer is a renowned CTD dossier owner and manufacturer based in Sejong, South Korea, with approximately 342 employees. As a GMP manufacturer, it specializes in producing over-the-counter (OTC) pharmaceutical products, including plasters, aerosols, topical liquids, emollients, hygiene products, ointments, adhesive bandages, mosquito repellents, anti-perspirants, cooling sheets, and bruise treatment creams. The Manufacturer's products are exported to approximately 30 countries worldwide. As a CTD dossier owner and manufacturer, it ensures compliance with international regulatory standards. Committed to excellence, this GMP manufacturer continues to expand its global presence, delivering high-quality healthcare solutions.​

Manufacturer usually replies in 30 days

terbinafine

Cream 10 mg/g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
PICS
Manufacturer #35087

Established in 2020, this manufacturer employs approximately 677 individuals and specializes in providing comprehensive pharmaceutical manufacturing services, including product development, analytical and regulatory services, as well as clinical and commercial manufacturing and packaging for various dosage forms. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, ensuring compliance with stringent quality standards. The manufacturer operates advanced production lines adhering to rigorous GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed in over 20 countries worldwide.

Manufacturer usually replies in 15 days

terbinafine

Cream 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
PICS
Manufacturer #18707
It was established in the 1980s. The company has continued to attain strong growth and has sprung into a global biotech company with a continuous trade surplus in the global market. The company manufactures more than 150 pharmaceutical products, and approved products are more than 340 products from MFDS (Ministry of Food and Drug Safety). For the quality intensification and maximizing of productive capacity, the company completely equipped its manufacturing structure and facilities for producing pharmaceutical products guaranteed safety and effectiveness with stability.

Manufacturer usually replies in 56 days

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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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