Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
01 1CURIA FRANCE S.A.S. Bon-Encontre FR
02 1Dishman Pharmaceuticals and Chemicals Limited Ahmedabad IN
01 2Hexetidine
01 1India
02 1U.S.A
01 1Valid
02 1Withdrawn by Holder
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Certificate Number : R1-CEP 2005-238 - Rev 03
Status : Valid
Issue Date : 2022-08-25
Type : Chemical
Substance Number : 1221
Certificate Number : R0-CEP 2010-238 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2012-09-10
Type : Chemical
Substance Number : 1221
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A Oraldene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oraldene, including repackagers and relabelers. The FDA regulates Oraldene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oraldene API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Oraldene supplier is an individual or a company that provides Oraldene active pharmaceutical ingredient (API) or Oraldene finished formulations upon request. The Oraldene suppliers may include Oraldene API manufacturers, exporters, distributors and traders.
click here to find a list of Oraldene suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Oraldene CEP of the European Pharmacopoeia monograph is often referred to as a Oraldene Certificate of Suitability (COS). The purpose of a Oraldene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oraldene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oraldene to their clients by showing that a Oraldene CEP has been issued for it. The manufacturer submits a Oraldene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oraldene CEP holder for the record. Additionally, the data presented in the Oraldene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oraldene DMF.
A Oraldene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oraldene CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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