01 1Chemische Fabrik Berg GmbH Bitterfeld-Wolfen DE
02 1RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A. Milano IT
03 1SHANGHAI WONDER PHARMACEUTICAL CO., LTD Shanghai CN
01 3Dimenhydrinate
01 1China
02 1Germany
03 1Italy
01 3Valid
Certificate Number : R1-CEP 2000-235 - Rev 05
Status : Valid
Issue Date : 2022-01-13
Type : Chemical
Substance Number : 601
Certificate Number : CEP 2017-283 - Rev 01
Status : Valid
Issue Date : 2024-01-19
Type : Chemical
Substance Number : 601
Certificate Number : CEP 2020-110 - Rev 01
Status : Valid
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 601
A Dimenhydrinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dimenhydrinate, including repackagers and relabelers. The FDA regulates Dimenhydrinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dimenhydrinate 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 Dimenhydrinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dimenhydrinate supplier is an individual or a company that provides Dimenhydrinate active pharmaceutical ingredient (API) or Dimenhydrinate finished formulations upon request. The Dimenhydrinate suppliers may include Dimenhydrinate API manufacturers, exporters, distributors and traders.
click here to find a list of Dimenhydrinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dimenhydrinate CEP of the European Pharmacopoeia monograph is often referred to as a Dimenhydrinate Certificate of Suitability (COS). The purpose of a Dimenhydrinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dimenhydrinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dimenhydrinate to their clients by showing that a Dimenhydrinate CEP has been issued for it. The manufacturer submits a Dimenhydrinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dimenhydrinate CEP holder for the record. Additionally, the data presented in the Dimenhydrinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dimenhydrinate DMF.
A Dimenhydrinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dimenhydrinate 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 Dimenhydrinate suppliers with CEP (COS) on PharmaCompass.
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