01 1Ash Stevens LLC
01 1Takeda Pharmaceutical Korea
01 1Ixazomibcitrate
01 1U.S.A
Registrant Name : Takeda Pharmaceutical Korea
Registration Date : 2019-01-29
Registration Number : 20190308-211-J-316
Manufacturer Name : Ash Stevens LLC
Manufacturer Address : 18655 Krause St. Riverview, MI 48193 USA
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A Ninlaro manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ninlaro, including repackagers and relabelers. The FDA regulates Ninlaro manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ninlaro 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 Ninlaro manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ninlaro supplier is an individual or a company that provides Ninlaro active pharmaceutical ingredient (API) or Ninlaro finished formulations upon request. The Ninlaro suppliers may include Ninlaro API manufacturers, exporters, distributors and traders.
click here to find a list of Ninlaro 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 Ninlaro Drug Master File in Korea (Ninlaro KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ninlaro. The MFDS reviews the Ninlaro KDMF as part of the drug registration process and uses the information provided in the Ninlaro KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ninlaro 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 Ninlaro API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ninlaro suppliers with KDMF on PharmaCompass.
