01 1ROVI ESCÚZAR, SL
01 1Ilsung IS Co., Ltd.
01 1Bemiparin sodium
01 1Blank
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
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A Heparin natrium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparin natrium, including repackagers and relabelers. The FDA regulates Heparin natrium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparin natrium 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 Heparin natrium supplier is an individual or a company that provides Heparin natrium active pharmaceutical ingredient (API) or Heparin natrium finished formulations upon request. The Heparin natrium suppliers may include Heparin natrium 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 Heparin natrium Drug Master File in Korea (Heparin natrium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Heparin natrium. The MFDS reviews the Heparin natrium KDMF as part of the drug registration process and uses the information provided in the Heparin natrium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Heparin natrium 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 Heparin natrium API can apply through the Korea Drug Master File (KDMF).
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