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 3Germany
02 2India
03 1Taiwan
04 1U.S.A
01 5Active
02 2Inactive
01 7Blank
01 1224MF10077
02 6Blank
01 7Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-06
Pay. Date : 2014-04-07
DMF Number : 26075
Submission : 2012-05-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-23
Pay. Date : 2017-01-20
DMF Number : 31325
Submission : 2017-01-31
Status : Active
Type : II
NDC Package Code : 72659-245
Start Marketing Date : 2018-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33453
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-12
Pay. Date : 2019-06-14
DMF Number : 33758
Submission : 2019-06-07
Status : Active
Type : II
NDC Package Code : 64757-0001
Start Marketing Date : 2014-11-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20033
Submission : 2006-12-13
Status : Active
Type : II
Registration Number : 224MF10077
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2012-04-08
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21092
Submission : 2007-12-03
Status : Inactive
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.
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