01 1Changzhou SynTheAll Pharmaceutical Co., Ltd.
02 1MSN Laboratories Private Limited, Unit-III
01 1B1 Medison Korea Co., Ltd.
02 1Gukjeon Co., Ltd.
01 2Janubrutinib
01 1China
02 1India
Registrant Name : Gukjeon Co., Ltd.
Registration Date : 2026-02-19
Registration Number : Su173-70-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : Sy. No. 111/E & 111/EE, Cheriyal Village, Kandi Mandal, Sangareddy District, Pincode ...
Registrant Name : B1 Medison Korea Co., Ltd.
Registration Date : 2022-09-16
Registration Number : Number 969-1-ND
Manufacturer Name : Changzhou SynTheAll Pharmace...
Manufacturer Address : 589 North Yulong Road, Xinbei District Changzhou, Jiangsu, 213127, China
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PharmaCompass offers a list of Zanubrutinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Zanubrutinib manufacturer or Zanubrutinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zanubrutinib manufacturer or Zanubrutinib supplier.
A Zanubrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zanubrutinib, including repackagers and relabelers. The FDA regulates Zanubrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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.
A Zanubrutinib supplier is an individual or a company that provides Zanubrutinib active pharmaceutical ingredient (API) or Zanubrutinib finished formulations upon request. The Zanubrutinib suppliers may include Zanubrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Zanubrutinib 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 Zanubrutinib Drug Master File in Korea (Zanubrutinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zanubrutinib. The MFDS reviews the Zanubrutinib KDMF as part of the drug registration process and uses the information provided in the Zanubrutinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a 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 Zanubrutinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zanubrutinib suppliers with KDMF on PharmaCompass.
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