01 1AVESTA PHARMA PVT. LTD. Mumbai IN
02 1BASF SE Ludwigshafen DE
03 1CLARIANT CHEMICALS (HUIZHOU) LTD. Huizhou CN
04 1CLARIANT PRODUKTE (DEUTSCHLAND) GMBH Frankfurt am Main DE
01 1Macrogols, Type 300, 400, 600, 1000, 1500, 3000, 3350, 4000 and 6000
02 3Macrogols, Type 3350
01 1China
02 1Germany
03 1India
04 1Switzerland
01 3Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 2013-222 - Rev 01
Status : Valid
Issue Date : 2023-01-20
Type : Chemical
Substance Number : 1444
Certificate Number : R1-CEP 2011-028 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2020-03-17
Type : Chemical
Substance Number : 1444
Macrogols, Type 300, 400, 600, 1000, 1500, 3000,...
Certificate Number : CEP 2002-180 - Rev 06
Status : Valid
Issue Date : 2024-11-04
Type : Chemical
Substance Number : 1444
Certificate Number : CEP 2020-432 - Rev 01
Status : Valid
Issue Date : 2024-08-13
Type : Chemical
Substance Number : 1444
A Macrogol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Macrogol, including repackagers and relabelers. The FDA regulates Macrogol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Macrogol 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 Macrogol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Macrogol supplier is an individual or a company that provides Macrogol active pharmaceutical ingredient (API) or Macrogol finished formulations upon request. The Macrogol suppliers may include Macrogol API manufacturers, exporters, distributors and traders.
click here to find a list of Macrogol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Macrogol CEP of the European Pharmacopoeia monograph is often referred to as a Macrogol Certificate of Suitability (COS). The purpose of a Macrogol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Macrogol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Macrogol to their clients by showing that a Macrogol CEP has been issued for it. The manufacturer submits a Macrogol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Macrogol CEP holder for the record. Additionally, the data presented in the Macrogol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Macrogol DMF.
A Macrogol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Macrogol 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 Macrogol suppliers with CEP (COS) on PharmaCompass.
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