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
A Topotecan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topotecan Hydrochloride, including repackagers and relabelers. The FDA regulates Topotecan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topotecan Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topotecan Hydrochloride supplier is an individual or a company that provides Topotecan Hydrochloride active pharmaceutical ingredient (API) or Topotecan Hydrochloride finished formulations upon request. The Topotecan Hydrochloride suppliers may include Topotecan Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Topotecan Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Topotecan Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Topotecan Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Topotecan Hydrochloride DMFs exist exist since differing nations have different regulations, such as Topotecan Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Topotecan Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Topotecan Hydrochloride USDMF includes data on Topotecan Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Topotecan Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Topotecan Hydrochloride suppliers with USDMF on PharmaCompass.
We have 8 companies offering Topotecan Hydrochloride
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