01 1Chemische Fabrik Berg
02 1Herbrand PharmaChemicals GmbH
03 1Macleods Pharmaceuticals Limited
04 1Roche Diagnostics GmbH
05 1Blank
01 16-PROPYL-2-THIOURACIL
02 3PROPYLTHIOURACIL
03 1PROPYLTHIOURACIL USP
01 3Germany
02 1India
03 1Blank
01 3Active
02 2Inactive
01 1Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16578
Submission : 2003-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4928
Submission : 1983-03-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-06
Pay. Date : 2015-05-12
DMF Number : 29101
Submission : 2015-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8377
Submission : 1990-01-15
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8278
Submission : 1989-10-03
Status : Inactive
Type : II
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A Propylthiouracil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propylthiouracil, including repackagers and relabelers. The FDA regulates Propylthiouracil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propylthiouracil 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 Propylthiouracil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Propylthiouracil supplier is an individual or a company that provides Propylthiouracil active pharmaceutical ingredient (API) or Propylthiouracil finished formulations upon request. The Propylthiouracil suppliers may include Propylthiouracil API manufacturers, exporters, distributors and traders.
click here to find a list of Propylthiouracil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Propylthiouracil DMF (Drug Master File) is a document detailing the whole manufacturing process of Propylthiouracil active pharmaceutical ingredient (API) in detail. Different forms of Propylthiouracil DMFs exist exist since differing nations have different regulations, such as Propylthiouracil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Propylthiouracil DMF submitted to regulatory agencies in the US is known as a USDMF. Propylthiouracil USDMF includes data on Propylthiouracil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Propylthiouracil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Propylthiouracil suppliers with USDMF on PharmaCompass.
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