01 1Union Quimica Farmaceutica SA
01 1Ibsen Korea Co., Ltd.
01 1Hexaminolevulinate hydrochloride
01 1Spain
Hexaminolevulinate hydrochloride
Registrant Name : Ibsen Korea Co., Ltd.
Registration Date : 2008-05-07
Registration Number : 3231-1-ND
Manufacturer Name : Union Quimica Farmaceutica S...
Manufacturer Address : Poligon Industrial Moli de les Planes, Font de Bocs S/N 08470, Sant Celoni, Barcelona
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A HEXAMINOLEVULINATE HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of HEXAMINOLEVULINATE HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates HEXAMINOLEVULINATE HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. HEXAMINOLEVULINATE 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 HEXAMINOLEVULINATE HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A HEXAMINOLEVULINATE HYDROCHLORIDE supplier is an individual or a company that provides HEXAMINOLEVULINATE HYDROCHLORIDE active pharmaceutical ingredient (API) or HEXAMINOLEVULINATE HYDROCHLORIDE finished formulations upon request. The HEXAMINOLEVULINATE HYDROCHLORIDE suppliers may include HEXAMINOLEVULINATE HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of HEXAMINOLEVULINATE HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 HEXAMINOLEVULINATE HYDROCHLORIDE Drug Master File in Korea (HEXAMINOLEVULINATE HYDROCHLORIDE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of HEXAMINOLEVULINATE HYDROCHLORIDE. The MFDS reviews the HEXAMINOLEVULINATE HYDROCHLORIDE KDMF as part of the drug registration process and uses the information provided in the HEXAMINOLEVULINATE HYDROCHLORIDE KDMF to evaluate the safety and efficacy of the drug.
After submitting a HEXAMINOLEVULINATE 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 HEXAMINOLEVULINATE HYDROCHLORIDE API can apply through the Korea Drug Master File (KDMF).
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