LEBSA- Your strategic API source for niche molecules.
01 2LABORATORIOS ESPINOS Y BOFILL SA (LEBSA)
01 1Jimax Pharmachem Co., Ltd.
02 1Samoh Pharmaceutical Co., Ltd.
01 2Betahistine dihydrochloride
01 2Spain
LEBSA- Your strategic API source for niche molecules.
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
LEBSA- Your strategic API source for niche molecules.
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 Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine Dihydrochloride, including repackagers and relabelers. The FDA regulates Betahistine Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine Dihydrochloride 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 Dihydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betahistine Dihydrochloride supplier is an individual or a company that provides Betahistine Dihydrochloride active pharmaceutical ingredient (API) or Betahistine Dihydrochloride finished formulations upon request. The Betahistine Dihydrochloride suppliers may include Betahistine Dihydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Betahistine Dihydrochloride 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 Dihydrochloride Drug Master File in Korea (Betahistine Dihydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Betahistine Dihydrochloride. The MFDS reviews the Betahistine Dihydrochloride KDMF as part of the drug registration process and uses the information provided in the Betahistine Dihydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Betahistine Dihydrochloride 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 Dihydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Betahistine Dihydrochloride suppliers with KDMF on PharmaCompass.
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