01 1Divis Laboratories
02 1Glenmark Life Sciences
03 1Hetero Drugs
04 1Ipca Laboratories
05 1Jacobus Pharmaceutical Company, Inc
06 1National Institutes of Health
07 1Sifavitor srl
08 1Taro Pharmaceutical Industries
09 1Viatris
10 1Zydus Lifesciences
01 1PALUDRINE
02 3PROGUANIL HYDROCHLORIDE
03 5PROGUANIL HYDROCHLORIDE USP
04 1PROGUANIL HYDROCHLORIDE, USP
01 5India
02 1Italy
03 4U.S.A
01 6Active
02 4Inactive
01 4Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-12-08
DMF Number : 18065
Submission : 2005-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32644
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-05
Pay. Date : 2017-08-09
DMF Number : 24998
Submission : 2011-05-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-07-30
DMF Number : 21475
Submission : 2008-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13857
Submission : 1998-11-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34
Submission : 1946-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23270
Submission : 2009-11-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-23
Pay. Date : 2014-02-28
DMF Number : 26103
Submission : 2012-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22059
Submission : 2008-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21461
Submission : 2008-03-26
Status : Inactive
Type : II
A Proguanil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Proguanil, including repackagers and relabelers. The FDA regulates Proguanil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Proguanil 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 Proguanil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Proguanil supplier is an individual or a company that provides Proguanil active pharmaceutical ingredient (API) or Proguanil finished formulations upon request. The Proguanil suppliers may include Proguanil API manufacturers, exporters, distributors and traders.
click here to find a list of Proguanil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Proguanil DMF (Drug Master File) is a document detailing the whole manufacturing process of Proguanil active pharmaceutical ingredient (API) in detail. Different forms of Proguanil DMFs exist exist since differing nations have different regulations, such as Proguanil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Proguanil DMF submitted to regulatory agencies in the US is known as a USDMF. Proguanil USDMF includes data on Proguanil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Proguanil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Proguanil suppliers with USDMF on PharmaCompass.
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