China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
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 leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
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
A Meldonium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meldonium, including repackagers and relabelers. The FDA regulates Meldonium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meldonium 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 Meldonium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meldonium supplier is an individual or a company that provides Meldonium active pharmaceutical ingredient (API) or Meldonium finished formulations upon request. The Meldonium suppliers may include Meldonium API manufacturers, exporters, distributors and traders.
click here to find a list of Meldonium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meldonium CEP of the European Pharmacopoeia monograph is often referred to as a Meldonium Certificate of Suitability (COS). The purpose of a Meldonium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Meldonium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Meldonium to their clients by showing that a Meldonium CEP has been issued for it. The manufacturer submits a Meldonium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Meldonium CEP holder for the record. Additionally, the data presented in the Meldonium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Meldonium DMF.
A Meldonium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meldonium 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 Meldonium suppliers with CEP (COS) on PharmaCompass.
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