Veranova: A CDMO that manages complexity with confidence.
01 1Veranova, L. P.
02 1Heraeus Precious Metals GmbH & Co. K.G.
01 2Cisplatin
01 1Germany
02 1U.S.A
Veranova: A CDMO that manages complexity with confidence.
Registration Number : 222MF10106
Registrant's Address : 435 Devon Park Drive, Suite 400, Wayne, Pennsylvania 19087 USA
Initial Date of Registration : 2010-03-19
Latest Date of Registration : 2010-03-19
Registration Number : 218MF10212
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2006-03-20
Latest Date of Registration : 2007-04-18
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Cisplatin Drug Master File in Japan (Cisplatin JDMF) empowers Cisplatin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Cisplatin JDMF during the approval evaluation for pharmaceutical products. At the time of Cisplatin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Cisplatin suppliers with JDMF on PharmaCompass.
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