ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Cipla
03 1Emcure Pharmaceuticals
04 1Fresenius Kabi AB Brunna
05 1Novartis Pharmaceuticals Corporation
06 1Sai Phytoceuticals
07 1ScinoPharm Taiwan, Ltd
08 1Synbias Pharma Limited Liability Company
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 22859
Submission : 2010-06-30
Status :
Type : II
22
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 8 companies offering Topotecan
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