01 2Heraeus Precious Metals GmbH & Co. K.G.
01 1Korea United Pharmaceutical Co., Ltd.
02 1Sungjin Exim Co., Ltd.
01 2Cisplatin
01 2Germany
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2019-04-10
Registration Number : 20190410-210-J-334
Manufacturer Name : Heraeus Precious Metals GmbH...
Manufacturer Address : Heraeusstraße 12-14 63450 Hanau, Germany
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2021-07-13
Registration Number : 20190410-210-J-334(1)
Manufacturer Name : Heraeus Precious Metals GmbH...
Manufacturer Address : Heraeusstrße 12-14, 63450 Hanau, Germany
A Cisplatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cisplatin, including repackagers and relabelers. The FDA regulates Cisplatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cisplatin 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 Cisplatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cisplatin supplier is an individual or a company that provides Cisplatin active pharmaceutical ingredient (API) or Cisplatin finished formulations upon request. The Cisplatin suppliers may include Cisplatin API manufacturers, exporters, distributors and traders.
click here to find a list of Cisplatin 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 Cisplatin Drug Master File in Korea (Cisplatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cisplatin. The MFDS reviews the Cisplatin KDMF as part of the drug registration process and uses the information provided in the Cisplatin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cisplatin 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 Cisplatin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cisplatin suppliers with KDMF on PharmaCompass.
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