01 1Thermo Fisher Scientific Cork Limited
01 1Novartis Korea Ltd.
01 1Lapatinib ditosylate
01 1U.S.A
Registrant Name : Novartis Korea Ltd.
Registration Date : 2007-07-24
Registration Number : 89-3-ND
Manufacturer Name : Thermo Fisher Scientific Cor...
Manufacturer Address : Currabinny, Carrigaline, Co, Cork, P43 AY66, Ireland
A Lapatinib Ditosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lapatinib Ditosylate, including repackagers and relabelers. The FDA regulates Lapatinib Ditosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lapatinib Ditosylate 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 Lapatinib Ditosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lapatinib Ditosylate supplier is an individual or a company that provides Lapatinib Ditosylate active pharmaceutical ingredient (API) or Lapatinib Ditosylate finished formulations upon request. The Lapatinib Ditosylate suppliers may include Lapatinib Ditosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Lapatinib Ditosylate 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 Lapatinib Ditosylate Drug Master File in Korea (Lapatinib Ditosylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lapatinib Ditosylate. The MFDS reviews the Lapatinib Ditosylate KDMF as part of the drug registration process and uses the information provided in the Lapatinib Ditosylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lapatinib Ditosylate 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 Lapatinib Ditosylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lapatinib Ditosylate suppliers with KDMF on PharmaCompass.
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