China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
01 1SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO., LTD. Dezhou City CN
02 1Joint Stock Company "Grindeks" Riga LV
01 2Meldonium dihydrate
01 1China
02 1Latvia
01 2Valid
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Certificate Number : CEP 2022-113 - Rev 01
Status : Valid
Issue Date : 2024-09-17
Type : Chemical
Substance Number : 2624
Certificate Number : R1-CEP 2015-089 - Rev 01
Status : Valid
Issue Date : 2022-05-19
Type : Chemical
Substance Number : 2624
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A D10504 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D10504, including repackagers and relabelers. The FDA regulates D10504 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D10504 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 D10504 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A D10504 supplier is an individual or a company that provides D10504 active pharmaceutical ingredient (API) or D10504 finished formulations upon request. The D10504 suppliers may include D10504 API manufacturers, exporters, distributors and traders.
click here to find a list of D10504 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A D10504 CEP of the European Pharmacopoeia monograph is often referred to as a D10504 Certificate of Suitability (COS). The purpose of a D10504 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of D10504 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of D10504 to their clients by showing that a D10504 CEP has been issued for it. The manufacturer submits a D10504 CEP (COS) as part of the market authorization procedure, and it takes on the role of a D10504 CEP holder for the record. Additionally, the data presented in the D10504 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the D10504 DMF.
A D10504 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. D10504 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 D10504 suppliers with CEP (COS) on PharmaCompass.
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