01 1Changzhou SynTheAll Pharmaceutical Co., Ltd.
01 1Beijin Korea Co., Ltd.
01 1Janubrutinib
01 1China
Registrant Name : Beijin Korea Co., Ltd.
Registration Date : 2022-09-16
Registration Number : No. 969-1-ND
Manufacturer Name : Changzhou SynTheAll Pharmace...
Manufacturer Address : 589 North Yulong Road, Xinbei District Changzhou, Jiangsu, 213127, China
A (R)-Zanubrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (R)-Zanubrutinib, including repackagers and relabelers. The FDA regulates (R)-Zanubrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (R)-Zanubrutinib 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 (R)-Zanubrutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (R)-Zanubrutinib supplier is an individual or a company that provides (R)-Zanubrutinib active pharmaceutical ingredient (API) or (R)-Zanubrutinib finished formulations upon request. The (R)-Zanubrutinib suppliers may include (R)-Zanubrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of (R)-Zanubrutinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 (R)-Zanubrutinib Drug Master File in Korea ((R)-Zanubrutinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (R)-Zanubrutinib. The MFDS reviews the (R)-Zanubrutinib KDMF as part of the drug registration process and uses the information provided in the (R)-Zanubrutinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a (R)-Zanubrutinib 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 (R)-Zanubrutinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (R)-Zanubrutinib suppliers with KDMF on PharmaCompass.
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