01 1BIOVET J.S.C., RAZGRAD BRANCH Razgrad BG
02 1NINGXIA TAIYICIN BIOTECH CO., LTD. Yinchuan City CN
03 1SHANDONG LUKANG SHELILE PHARMACEUTICAL CO., LTD. Zoucheng CN
01 3Tylosin for veterinary use
01 1Bulgaria
02 2China
01 2Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 2007-305 - Rev 01
Status : Valid
Issue Date : 2018-03-21
Type : Chemical and TSE
Substance Number : 1273
Certificate Number : R0-CEP 2020-362 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2022-10-20
Type : Chemical
Substance Number : 1273
Certificate Number : R0-CEP 2020-189 - Rev 01
Status : Valid
Issue Date : 2022-03-25
Type : Chemical
Substance Number : 1273
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A E713 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of E713, including repackagers and relabelers. The FDA regulates E713 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. E713 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 E713 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A E713 supplier is an individual or a company that provides E713 active pharmaceutical ingredient (API) or E713 finished formulations upon request. The E713 suppliers may include E713 API manufacturers, exporters, distributors and traders.
click here to find a list of E713 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A E713 CEP of the European Pharmacopoeia monograph is often referred to as a E713 Certificate of Suitability (COS). The purpose of a E713 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of E713 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of E713 to their clients by showing that a E713 CEP has been issued for it. The manufacturer submits a E713 CEP (COS) as part of the market authorization procedure, and it takes on the role of a E713 CEP holder for the record. Additionally, the data presented in the E713 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the E713 DMF.
A E713 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. E713 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 E713 suppliers with CEP (COS) on PharmaCompass.
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