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 CYSVIEW KIT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CYSVIEW KIT, including repackagers and relabelers. The FDA regulates CYSVIEW KIT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CYSVIEW KIT API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A CYSVIEW KIT supplier is an individual or a company that provides CYSVIEW KIT active pharmaceutical ingredient (API) or CYSVIEW KIT finished formulations upon request. The CYSVIEW KIT suppliers may include CYSVIEW KIT API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a CYSVIEW KIT Drug Master File in Korea (CYSVIEW KIT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CYSVIEW KIT. The MFDS reviews the CYSVIEW KIT KDMF as part of the drug registration process and uses the information provided in the CYSVIEW KIT KDMF to evaluate the safety and efficacy of the drug.
After submitting a CYSVIEW KIT 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 CYSVIEW KIT API can apply through the Korea Drug Master File (KDMF).
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