01 1Inistesti Co., Ltd.
02 1Novartis Ringaskiddy Limited
01 1G-Therapeutics Korea Co., Ltd.
02 1Inistesti Co., Ltd.
01 2Terbinafine
01 1South Korea
02 1Switzerland
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2010-11-16
Registration Number : 20101116-49-A-248-15
Manufacturer Name : Inistesti Co., Ltd.
Manufacturer Address : 500 Shinnae-ro, Geumwang-eup, Eumseong-gun, Chungcheongbuk-do
Registrant Name : G-Therapeutics Korea Co., Ltd.
Registration Date : 2011-02-15
Registration Number : 20110215-49-A-244-16
Manufacturer Name : Novartis Ringaskiddy Limited
Manufacturer Address : Ringaskiddy, Co. Cork
A Terbinafine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terbinafine, including repackagers and relabelers. The FDA regulates Terbinafine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terbinafine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Terbinafine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Terbinafine supplier is an individual or a company that provides Terbinafine active pharmaceutical ingredient (API) or Terbinafine finished formulations upon request. The Terbinafine suppliers may include Terbinafine API manufacturers, exporters, distributors and traders.
click here to find a list of Terbinafine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Terbinafine Drug Master File in Korea (Terbinafine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Terbinafine. The MFDS reviews the Terbinafine KDMF as part of the drug registration process and uses the information provided in the Terbinafine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Terbinafine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Terbinafine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Terbinafine suppliers with KDMF on PharmaCompass.
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