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 Lioton 1000 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lioton 1000, including repackagers and relabelers. The FDA regulates Lioton 1000 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lioton 1000 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 Lioton 1000 supplier is an individual or a company that provides Lioton 1000 active pharmaceutical ingredient (API) or Lioton 1000 finished formulations upon request. The Lioton 1000 suppliers may include Lioton 1000 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 Lioton 1000 Drug Master File in Korea (Lioton 1000 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lioton 1000. The MFDS reviews the Lioton 1000 KDMF as part of the drug registration process and uses the information provided in the Lioton 1000 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lioton 1000 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 Lioton 1000 API can apply through the Korea Drug Master File (KDMF).
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