01 1YS Life Science Co., Ltd.
01 1YS Life Science Co., Ltd.
01 1Treprostinyl sodium
01 1South Korea
Registrant Name : YS Life Science Co., Ltd.
Registration Date : 2025-04-17
Registration Number : 20250417-210-J-1862
Manufacturer Name : YS Life Science Co., Ltd.
Manufacturer Address : 207 Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do
75
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A Remodulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remodulin, including repackagers and relabelers. The FDA regulates Remodulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remodulin 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 Remodulin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Remodulin supplier is an individual or a company that provides Remodulin active pharmaceutical ingredient (API) or Remodulin finished formulations upon request. The Remodulin suppliers may include Remodulin 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 Remodulin Drug Master File in Korea (Remodulin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Remodulin. The MFDS reviews the Remodulin KDMF as part of the drug registration process and uses the information provided in the Remodulin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Remodulin 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 Remodulin API can apply through the Korea Drug Master File (KDMF).
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