01 1AURORIUM LLC Midlothian US
02 1K+S MINERALS AND AGRICULTURE GMBH Kassel DE
03 1Klinge Chemicals Ltd East Kilbride GB
04 1MACCO ORGANIQUES, S.R.O. Bruntál CZ
01 4Potassium chloride
01 1Czech Republic
02 1Germany
03 1U.S.A
04 1United Kingdom
01 4Valid
Certificate Number : CEP 2003-263 - Rev 05
Status : Valid
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 185
Certificate Number : CEP 2010-380 - Rev 05
Status : Valid
Issue Date : 2024-07-15
Type : Chemical
Substance Number : 185
Certificate Number : CEP 2001-435 - Rev 02
Status : Valid
Issue Date : 2024-09-17
Type : Chemical
Substance Number : 185
Certificate Number : R0-CEP 2018-159 - Rev 00
Status : Valid
Issue Date : 2020-02-19
Type : Chemical
Substance Number : 185
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 CEP of the European Pharmacopoeia monograph is often referred to as a K-Dur Certificate of Suitability (COS). The purpose of a K-Dur CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of K-Dur EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of K-Dur to their clients by showing that a K-Dur CEP has been issued for it. The manufacturer submits a K-Dur CEP (COS) as part of the market authorization procedure, and it takes on the role of a K-Dur CEP holder for the record. Additionally, the data presented in the K-Dur CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the K-Dur DMF.
A K-Dur CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. K-Dur CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of K-Dur suppliers with CEP (COS) on PharmaCompass.
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