ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1ChemCon GmbH
03 1Emcure Pharmaceuticals
04 1Heraeus Holding
05 1TTY BIOPHARM CO LTD
06 1Umicore
07 1Zydus Lifesciences
01 5ARSENIC TRIOXIDE
02 1ARSENIC TRIOXIDE USP
03 1Arsenic Trioxide
01 3Germany
02 2India
03 1Taiwan
04 1U.S.A
01 5Active
02 2Inactive
01 3Complete
02 4Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-06
Pay. Date : 2014-04-07
DMF Number : 26075
Submission : 2012-05-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-12
Pay. Date : 2019-06-14
DMF Number : 33758
Submission : 2019-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33453
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20033
Submission : 2006-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21092
Submission : 2007-12-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2017-01-20
DMF Number : 31325
Submission : 2017-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27382
Submission : 2013-09-23
Status : Inactive
Type : II
A Arsenic Trioxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arsenic Trioxide, including repackagers and relabelers. The FDA regulates Arsenic Trioxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arsenic Trioxide 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 Arsenic Trioxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arsenic Trioxide supplier is an individual or a company that provides Arsenic Trioxide active pharmaceutical ingredient (API) or Arsenic Trioxide finished formulations upon request. The Arsenic Trioxide suppliers may include Arsenic Trioxide API manufacturers, exporters, distributors and traders.
click here to find a list of Arsenic Trioxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Arsenic Trioxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Arsenic Trioxide active pharmaceutical ingredient (API) in detail. Different forms of Arsenic Trioxide DMFs exist exist since differing nations have different regulations, such as Arsenic Trioxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arsenic Trioxide DMF submitted to regulatory agencies in the US is known as a USDMF. Arsenic Trioxide USDMF includes data on Arsenic Trioxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arsenic Trioxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arsenic Trioxide suppliers with USDMF on PharmaCompass.
We have 7 companies offering Arsenic Trioxide
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