01 2Fresenius Kabi Austria GmbH Linz AT
02 2SERUMWERK BERNBURG AG Bernburg DE
01 1Starches, hydroxyethyl, Mw 130, MS 0.42, C2/C6 6
02 2Starches, hydroxyethyl, Mw 200, MS 0.5, C2/C6 6
03 1Starches, hydroxyethyl, Mw 450, MS 0.7, C2/C6 5
01 2Austria
02 2Germany
01 4Valid
Starches, Hydroxyethyl, Mw 200, MS 0.5, C2/C6 6
Certificate Number : R1-CEP 2010-242 - Rev 00
Status : Valid
Issue Date : 2017-06-29
Type : Chemical
Substance Number : 1785
Starches, Hydroxyethyl, Mw 450, MS 0.7, C2/C6 5
Certificate Number : R1-CEP 2010-284 - Rev 00
Status : Valid
Issue Date : 2017-06-29
Type : Chemical
Substance Number : 1785
Starches, Hydroxyethyl, Mw 130, MS 0.42, C2/C6 6
Certificate Number : R1-CEP 2013-234 - Rev 00
Status : Valid
Issue Date : 2019-06-21
Type : Chemical
Substance Number : 1785
Starches, Hydroxyethyl, Mw 200, MS 0.5, C2/C6 6
Certificate Number : R1-CEP 2014-281 - Rev 00
Status : Valid
Issue Date : 2020-03-26
Type : Chemical
Substance Number : 1785
A Cornstarch manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cornstarch, including repackagers and relabelers. The FDA regulates Cornstarch manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cornstarch 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 Cornstarch manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cornstarch supplier is an individual or a company that provides Cornstarch active pharmaceutical ingredient (API) or Cornstarch finished formulations upon request. The Cornstarch suppliers may include Cornstarch API manufacturers, exporters, distributors and traders.
click here to find a list of Cornstarch suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cornstarch CEP of the European Pharmacopoeia monograph is often referred to as a Cornstarch Certificate of Suitability (COS). The purpose of a Cornstarch CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cornstarch EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cornstarch to their clients by showing that a Cornstarch CEP has been issued for it. The manufacturer submits a Cornstarch CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cornstarch CEP holder for the record. Additionally, the data presented in the Cornstarch CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cornstarch DMF.
A Cornstarch CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cornstarch 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 Cornstarch suppliers with CEP (COS) on PharmaCompass.
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