01 1Adare Pharma Solutions
02 1Chemtrade Solutions LLC
03 1EURAND
04 1F. Hoffmann-La Roche
05 1Glenmark Life Sciences
06 1Global Calcium
07 1India Phosphate
08 1K+S Kali GmbH
09 1Klinge Chemicals Ltd
10 1Macco Organiques, Spol. s.r o
11 1Mallinckrodt Pharmaceuticals
12 2Morton Salt
13 1Nandu Chemicals
14 1THINQ Pharma-CRO PVT Ltd
15 1VM Chemicals
16 1Wuhan Shiji Pharmaceutical
01 1MICROCAPS® POTASSIUM CHLORIDE
02 1MORTON USP POTASSIUM CHLORIDE
03 4POTASSIUM CHLORIDE
04 1POTASSIUM CHLORIDE 99.9% KCI PH. EUR., USP
05 2POTASSIUM CHLORIDE BP
06 1POTASSIUM CHLORIDE MICROCAPS COMPRESSIBLE
07 1POTASSIUM CHLORIDE SUSTAINED RELEASE CAPSULES 600MG
08 5POTASSIUM CHLORIDE USP
09 1USP POTASSIUM CHLORIDE
01 1Canada
02 1China
03 1Czech Republic
04 1Germany
05 6India
06 1Ireland
07 1Switzerland
08 4U.S.A
09 1United Kingdom
01 12Active
02 5Inactive
01 6Complete
02 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6118
Submission : 1985-12-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-26
Pay. Date : 2013-04-19
DMF Number : 5440
Submission : 1984-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-11-03
DMF Number : 28651
Submission : 2014-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31771
Submission : 2017-09-06
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2014-06-25
DMF Number : 25595
Submission : 2012-06-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-04
Pay. Date : 2013-08-21
DMF Number : 3953
Submission : 1980-08-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31851
Submission : 2017-09-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-13
Pay. Date : 2018-05-25
DMF Number : 30511
Submission : 2016-10-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25840
Submission : 2011-11-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29040
Submission : 2015-01-06
Status : Active
Type : II
A K-Dur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of K-Dur, including repackagers and relabelers. The FDA regulates K-Dur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. K-Dur 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 K-Dur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A K-Dur supplier is an individual or a company that provides K-Dur active pharmaceutical ingredient (API) or K-Dur finished formulations upon request. The K-Dur suppliers may include K-Dur API manufacturers, exporters, distributors and traders.
click here to find a list of K-Dur suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A K-Dur DMF (Drug Master File) is a document detailing the whole manufacturing process of K-Dur active pharmaceutical ingredient (API) in detail. Different forms of K-Dur DMFs exist exist since differing nations have different regulations, such as K-Dur USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A K-Dur DMF submitted to regulatory agencies in the US is known as a USDMF. K-Dur USDMF includes data on K-Dur's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The K-Dur USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of K-Dur suppliers with USDMF on PharmaCompass.
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