01 1ROVI ESCÚZAR, SL
01 1Ilsung IS Co., Ltd.
01 1Bemiparin sodium
01 1Spain
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2025-02-21
Registration Number : 20250221-211-J-1761
Manufacturer Name : ROVI ESCÚZAR, SL
Manufacturer Address : Avenida de la Serrezuela, 5518130 ESCÚZAR (GRANADA), SPAIN
97
PharmaCompass offers a list of Dalteparin sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dalteparin sodium manufacturer or Dalteparin sodium supplier for your needs.
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A Fluxum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluxum, including repackagers and relabelers. The FDA regulates Fluxum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluxum 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 Fluxum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Fluxum supplier is an individual or a company that provides Fluxum active pharmaceutical ingredient (API) or Fluxum finished formulations upon request. The Fluxum suppliers may include Fluxum API manufacturers, exporters, distributors and traders.
click here to find a list of Fluxum 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 Fluxum Drug Master File in Korea (Fluxum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fluxum. The MFDS reviews the Fluxum KDMF as part of the drug registration process and uses the information provided in the Fluxum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fluxum 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 Fluxum API can apply through the Korea Drug Master File (KDMF).
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