01 1ChemPacific Corp
02 1Pfizer Inc
03 1Viatris
01 1COVIDARABINE
02 2PENTOSTATIN
01 3U.S.A
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18235
Submission : 2005-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2954
Submission : 1977-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24862
Submission : 2011-07-05
Status : Active
Type : II
A Pentostatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentostatin, including repackagers and relabelers. The FDA regulates Pentostatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentostatin 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 Pentostatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentostatin supplier is an individual or a company that provides Pentostatin active pharmaceutical ingredient (API) or Pentostatin finished formulations upon request. The Pentostatin suppliers may include Pentostatin API manufacturers, exporters, distributors and traders.
click here to find a list of Pentostatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentostatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentostatin active pharmaceutical ingredient (API) in detail. Different forms of Pentostatin DMFs exist exist since differing nations have different regulations, such as Pentostatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentostatin DMF submitted to regulatory agencies in the US is known as a USDMF. Pentostatin USDMF includes data on Pentostatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentostatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentostatin suppliers with USDMF on PharmaCompass.
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