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01 2LABORATORIOS ESPINOS Y BOFILL SA (LEBSA)
01 1Jimax Pharmachem Co., Ltd.
02 1Samoh Pharmaceutical Co., Ltd.
01 2Betahistine dihydrochloride
01 2Spain
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2024-11-12
Registration Number : 20220916-211-J-1364(A)
Manufacturer Name : LABORATORIOS ESPINOS Y BOFIL...
Manufacturer Address : Ctra. De L'Hospitalet, 34 08940 Cornellà De Llobregat, Barcelona, Spain
Registrant Name : Jimax Pharmachem Co., Ltd.
Registration Date : 2022-09-16
Registration Number : 20220916-211-J-1364
Manufacturer Name : LABORATORIOS ESPINOS Y BOFIL...
Manufacturer Address : Ctra. De L'Hospitalet, 34 08940 Cornellà De Llobregat, Barcelona, Spain
A Betahistine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine Hydrochloride, including repackagers and relabelers. The FDA regulates Betahistine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine 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 Betahistine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betahistine Hydrochloride supplier is an individual or a company that provides Betahistine Hydrochloride active pharmaceutical ingredient (API) or Betahistine Hydrochloride finished formulations upon request. The Betahistine Hydrochloride suppliers may include Betahistine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Betahistine 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 Betahistine Hydrochloride Drug Master File in Korea (Betahistine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betahistine Hydrochloride. The MFDS reviews the Betahistine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Betahistine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betahistine 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 Betahistine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Betahistine Hydrochloride suppliers with KDMF on PharmaCompass.
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