01 1Kaken Pharmaceutical Co., Ltd. Shizuoka Factory
01 1Samoh Pharmaceutical Co., Ltd.
01 1Butenapine hydrochloride
01 1Japan
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-03-23
Registration Number : 20230323-211-J-1455
Manufacturer Name : Kaken Pharmaceutical Co., Lt...
Manufacturer Address : 301-banchi, Gensuke, Fujieda-City, Shizuoka 426-8646, Japan
A Butenafine (Hydrochloride) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butenafine (Hydrochloride), including repackagers and relabelers. The FDA regulates Butenafine (Hydrochloride) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butenafine (Hydrochloride) 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 Butenafine (Hydrochloride) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butenafine (Hydrochloride) supplier is an individual or a company that provides Butenafine (Hydrochloride) active pharmaceutical ingredient (API) or Butenafine (Hydrochloride) finished formulations upon request. The Butenafine (Hydrochloride) suppliers may include Butenafine (Hydrochloride) API manufacturers, exporters, distributors and traders.
click here to find a list of Butenafine (Hydrochloride) 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 Butenafine (Hydrochloride) Drug Master File in Korea (Butenafine (Hydrochloride) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Butenafine (Hydrochloride). The MFDS reviews the Butenafine (Hydrochloride) KDMF as part of the drug registration process and uses the information provided in the Butenafine (Hydrochloride) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Butenafine (Hydrochloride) 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 Butenafine (Hydrochloride) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Butenafine (Hydrochloride) suppliers with KDMF on PharmaCompass.
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