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
66
PharmaCompass offers a list of Topotecan Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Topotecan Hydrochloride manufacturer or Topotecan Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Topotecan Hydrochloride manufacturer or Topotecan Hydrochloride supplier.
PharmaCompass also assists you with knowing the Topotecan Hydrochloride API Price utilized in the formulation of products. Topotecan Hydrochloride API Price is not always fixed or binding as the Topotecan Hydrochloride Price is obtained through a variety of data sources. The Topotecan Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Topotecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topotecan, including repackagers and relabelers. The FDA regulates Topotecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topotecan 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 Topotecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topotecan supplier is an individual or a company that provides Topotecan active pharmaceutical ingredient (API) or Topotecan finished formulations upon request. The Topotecan suppliers may include Topotecan API manufacturers, exporters, distributors and traders.
click here to find a list of Topotecan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Topotecan DMF (Drug Master File) is a document detailing the whole manufacturing process of Topotecan active pharmaceutical ingredient (API) in detail. Different forms of Topotecan DMFs exist exist since differing nations have different regulations, such as Topotecan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Topotecan DMF submitted to regulatory agencies in the US is known as a USDMF. Topotecan USDMF includes data on Topotecan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Topotecan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Topotecan suppliers with USDMF on PharmaCompass.
We have 6 companies offering Topotecan
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