01 2Pfizer Inc
02 1Blank
01 19-AMINOCAMPTOTHECIN ACTIVE DRUG SUBSTANCE
02 19-AMINOCAMPTOTHECIN COLLOIDAL DISPERSION
03 19-AMINOCAMPTOTHECIN COLLOIDAL DISPERSION AND DILUENT
01 2U.S.A
02 1Blank
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13008
Submission : 1998-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11335
Submission : 1995-02-07
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11328
Submission : 1995-02-07
Status : Inactive
Type : II
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A 9-Aminocamptothecin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 9-Aminocamptothecin, including repackagers and relabelers. The FDA regulates 9-Aminocamptothecin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 9-Aminocamptothecin 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 9-Aminocamptothecin supplier is an individual or a company that provides 9-Aminocamptothecin active pharmaceutical ingredient (API) or 9-Aminocamptothecin finished formulations upon request. The 9-Aminocamptothecin suppliers may include 9-Aminocamptothecin API manufacturers, exporters, distributors and traders.
click here to find a list of 9-Aminocamptothecin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 9-Aminocamptothecin DMF (Drug Master File) is a document detailing the whole manufacturing process of 9-Aminocamptothecin active pharmaceutical ingredient (API) in detail. Different forms of 9-Aminocamptothecin DMFs exist exist since differing nations have different regulations, such as 9-Aminocamptothecin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 9-Aminocamptothecin DMF submitted to regulatory agencies in the US is known as a USDMF. 9-Aminocamptothecin USDMF includes data on 9-Aminocamptothecin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 9-Aminocamptothecin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 9-Aminocamptothecin suppliers with USDMF on PharmaCompass.
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