01 1MSN Laboratories Private Limited
01 1Kukjeon Pharmaceutical Co., Ltd.
01 1Ibrutinib
01 1India
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2025-04-18
Registration Number : Su173-55-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
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A IMBRUVICA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of IMBRUVICA, including repackagers and relabelers. The FDA regulates IMBRUVICA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. IMBRUVICA 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 IMBRUVICA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A IMBRUVICA supplier is an individual or a company that provides IMBRUVICA active pharmaceutical ingredient (API) or IMBRUVICA finished formulations upon request. The IMBRUVICA suppliers may include IMBRUVICA API manufacturers, exporters, distributors and traders.
click here to find a list of IMBRUVICA 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 IMBRUVICA Drug Master File in Korea (IMBRUVICA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of IMBRUVICA. The MFDS reviews the IMBRUVICA KDMF as part of the drug registration process and uses the information provided in the IMBRUVICA KDMF to evaluate the safety and efficacy of the drug.
After submitting a IMBRUVICA 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 IMBRUVICA API can apply through the Korea Drug Master File (KDMF).
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