01 2HEC PHARM CO., LTD. Yidu City CN
02 1JIANGXI GUOYAO PHARMACEUTICAL LIMITED LIABILITY COMPANY Nanchang CN
03 1LIVZON GROUP (NINGXIA) PHARMACEUTICAL CO., LTD. Pingluo CN
04 1NANYANG PUKANG PHARMACEUTICAL CO., LTD. Nanyang CN
05 1NINGXIA TAIYICIN BIOTECH CO., LTD. Yinchuan City CN
06 1NORTH CHINA PHARMACEUTICAL GROUP HUALUAN CO., LTD. Shijiazhuang City CN
07 1TOPFOND PHARMACEUTICAL CO., LTD. Zhumadian CN
08 2XINYU PHARMACEUTICAL CO., LTD. Suzhou City CN
01 8Lincomycin hydrochloride
02 1Lincomycin hydrochloride, Alternative process
03 1Lincomycin hydrochloride, Process III, code C20103
01 10China
01 6Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
Lincomycin Hydrochloride, Process III, Code C201...
Certificate Number : CEP 2019-136 - Rev 03
Status : Valid
Issue Date : 2024-11-19
Type : Chemical
Substance Number : 583
Certificate Number : CEP 2018-038 - Rev 02
Status : Valid
Issue Date : 2023-11-29
Type : Chemical
Substance Number : 583
Certificate Number : R1-CEP 2008-225 - Rev 02
Status : Valid
Issue Date : 2021-11-29
Type : Chemical
Substance Number : 583
Certificate Number : R1-CEP 2007-135 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2014-02-10
Type : Chemical
Substance Number : 583
Certificate Number : R0-CEP 2018-090 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2021-12-09
Type : Chemical
Substance Number : 583
Certificate Number : R0-CEP 2013-114 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2015-10-01
Type : Chemical
Substance Number : 583
Certificate Number : CEP 2017-155 - Rev 01
Status : Valid
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 583
Certificate Number : R1-CEP 2007-295 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2017-04-13
Type : Chemical
Substance Number : 583
Certificate Number : CEP 2017-168 - Rev 01
Status : Valid
Issue Date : 2024-07-16
Type : Chemical
Substance Number : 583
Lincomycin Hydrochloride, Alternative Process
Certificate Number : CEP 2020-105 - Rev 02
Status : Valid
Issue Date : 2025-04-29
Type : Chemical
Substance Number : 583
57
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A U 10149a manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of U 10149a, including repackagers and relabelers. The FDA regulates U 10149a manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. U 10149a API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A U 10149a supplier is an individual or a company that provides U 10149a active pharmaceutical ingredient (API) or U 10149a finished formulations upon request. The U 10149a suppliers may include U 10149a API manufacturers, exporters, distributors and traders.
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A U 10149a CEP of the European Pharmacopoeia monograph is often referred to as a U 10149a Certificate of Suitability (COS). The purpose of a U 10149a CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of U 10149a EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of U 10149a to their clients by showing that a U 10149a CEP has been issued for it. The manufacturer submits a U 10149a CEP (COS) as part of the market authorization procedure, and it takes on the role of a U 10149a CEP holder for the record. Additionally, the data presented in the U 10149a CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the U 10149a DMF.
A U 10149a CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. U 10149a 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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