01 1CHENGDA PHARMACEUTICALS CO., LTD. Jiashan CN
02 1NORTHEAST PHARMACEUTICAL GROUP COMPANY, LIMITED Shenyang CN
03 2PHARMARESOURCES (KAIYUAN) COMPANY LIMITED Kaiyuan City CN
01 4Levocarnitine
01 4China
01 3Valid
02 1Withdrawn by Holder
Certificate Number : R0-CEP 2019-293 - Rev 01
Status : Valid
Issue Date : 2023-03-24
Type : Chemical
Substance Number : 1339
Certificate Number : CEP 2022-084 - Rev 00
Status : Valid
Issue Date : 2024-09-16
Type : Chemical
Substance Number : 1339
Certificate Number : R1-CEP 2014-044 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2020-08-04
Type : Chemical
Substance Number : 1339
Certificate Number : CEP 2022-068 - Rev 00
Status : Valid
Issue Date : 2024-01-19
Type : Chemical
Substance Number : 1339
A Levocarnitine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levocarnitine, including repackagers and relabelers. The FDA regulates Levocarnitine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levocarnitine 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 Levocarnitine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levocarnitine supplier is an individual or a company that provides Levocarnitine active pharmaceutical ingredient (API) or Levocarnitine finished formulations upon request. The Levocarnitine suppliers may include Levocarnitine API manufacturers, exporters, distributors and traders.
click here to find a list of Levocarnitine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levocarnitine CEP of the European Pharmacopoeia monograph is often referred to as a Levocarnitine Certificate of Suitability (COS). The purpose of a Levocarnitine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levocarnitine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levocarnitine to their clients by showing that a Levocarnitine CEP has been issued for it. The manufacturer submits a Levocarnitine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levocarnitine CEP holder for the record. Additionally, the data presented in the Levocarnitine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levocarnitine DMF.
A Levocarnitine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levocarnitine 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 Levocarnitine suppliers with CEP (COS) on PharmaCompass.
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