01 1Yuhan Chemical Co., Ltd.
01 1Yuhan Chemical Co., Ltd.
01 1Lasertinib
01 1South Korea
Registrant Name : Yuhan Chemical Co., Ltd.
Registration Date : 2021-01-18
Registration Number : 1791-9-ND
Manufacturer Name : Yuhan Chemical Co., Ltd.
Manufacturer Address : 402, 5-ba, Sihwa Industrial Complex, 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do (S...
A Lazertinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lazertinib, including repackagers and relabelers. The FDA regulates Lazertinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lazertinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lazertinib supplier is an individual or a company that provides Lazertinib active pharmaceutical ingredient (API) or Lazertinib finished formulations upon request. The Lazertinib suppliers may include Lazertinib API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Lazertinib Drug Master File in Korea (Lazertinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lazertinib. The MFDS reviews the Lazertinib KDMF as part of the drug registration process and uses the information provided in the Lazertinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lazertinib 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 Lazertinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lazertinib suppliers with KDMF on PharmaCompass.
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