01 1Cyclacel Pharmaceuticals
01 1CS-682
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12513
Submission : 1997-05-23
Status : Inactive
Type : II
A Sapacitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sapacitabine, including repackagers and relabelers. The FDA regulates Sapacitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sapacitabine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Sapacitabine supplier is an individual or a company that provides Sapacitabine active pharmaceutical ingredient (API) or Sapacitabine finished formulations upon request. The Sapacitabine suppliers may include Sapacitabine API manufacturers, exporters, distributors and traders.
click here to find a list of Sapacitabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sapacitabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Sapacitabine active pharmaceutical ingredient (API) in detail. Different forms of Sapacitabine DMFs exist exist since differing nations have different regulations, such as Sapacitabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sapacitabine DMF submitted to regulatory agencies in the US is known as a USDMF. Sapacitabine USDMF includes data on Sapacitabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sapacitabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sapacitabine suppliers with USDMF on PharmaCompass.
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