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