01 1Cipla
02 1Emcure Pharmaceuticals
03 1Fresenius Kabi AB Brunna
04 1Novartis Pharmaceuticals Corporation
05 1ScinoPharm Taiwan Ltd
06 1Synbias Pharma Limited Liability Company
01 5TOPOTECAN HYDROCHLORIDE
02 1TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE
01 2India
02 1Sweden
03 1Switzerland
04 1Taiwan
05 1Ukraine
01 3Active
02 3Inactive
01 1Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21621
Submission : 2008-07-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23443
Submission : 2010-01-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22303
Submission : 2009-01-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24458
Submission : 2011-02-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-18
DMF Number : 20810
Submission : 2007-08-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23682
Submission : 2010-03-29
Status : Inactive
Type : II
22
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A Topotecan HCl - Hycamtin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topotecan HCl - Hycamtin, including repackagers and relabelers. The FDA regulates Topotecan HCl - Hycamtin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topotecan HCl - Hycamtin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Topotecan HCl - Hycamtin DMF (Drug Master File) is a document detailing the whole manufacturing process of Topotecan HCl - Hycamtin active pharmaceutical ingredient (API) in detail. Different forms of Topotecan HCl - Hycamtin DMFs exist exist since differing nations have different regulations, such as Topotecan HCl - Hycamtin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Topotecan HCl - Hycamtin DMF submitted to regulatory agencies in the US is known as a USDMF. Topotecan HCl - Hycamtin USDMF includes data on Topotecan HCl - Hycamtin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Topotecan HCl - Hycamtin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 6 companies offering Topotecan HCl - Hycamtin
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