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