Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1Andenex-Chemie Engelhard + Partner GmbH
03 1Heraeus Holding
04 1Hetero Drugs
05 1IDT Australia Limited
06 1Laurus Labs
07 1Plantex Ltd.
08 1Qilu Pharmaceutical
09 1Strem Chemicals
10 1Umicore
11 2Blank
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9601
Submission : 1992-03-26
Status :
Type : II
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.
A Cisplatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Cisplatin active pharmaceutical ingredient (API) in detail. Different forms of Cisplatin DMFs exist exist since differing nations have different regulations, such as Cisplatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cisplatin DMF submitted to regulatory agencies in the US is known as a USDMF. Cisplatin USDMF includes data on Cisplatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cisplatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cisplatin suppliers with USDMF on PharmaCompass.
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