01 1MSN Laboratories Private Limited
01 1Kukjeon Pharmaceutical Co., Ltd.
01 1Crizotinib
01 1India
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2025-02-12
Registration Number : Su173-53-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : Unit-III, Sy. No. 111/E & 111/EE, Cheriyal (Village), Kandi (Mandal), Sangareddy Dist...
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A xalkori manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of xalkori, including repackagers and relabelers. The FDA regulates xalkori manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. xalkori 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 xalkori manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A xalkori supplier is an individual or a company that provides xalkori active pharmaceutical ingredient (API) or xalkori finished formulations upon request. The xalkori suppliers may include xalkori API manufacturers, exporters, distributors and traders.
click here to find a list of xalkori 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 xalkori Drug Master File in Korea (xalkori KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of xalkori. The MFDS reviews the xalkori KDMF as part of the drug registration process and uses the information provided in the xalkori KDMF to evaluate the safety and efficacy of the drug.
After submitting a xalkori 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 xalkori API can apply through the Korea Drug Master File (KDMF).
click here to find a list of xalkori suppliers with KDMF on PharmaCompass.
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