01 1CAMBREX CHARLES CITY, INC. Charles City US
02 1Calao s.r.l. Milano IT
03 1DAIICHI SANKYO CO., LTD. Tokyo JP
04 1QUIMICA SINTETICA S.A. Alcala De Henares ES
05 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
06 2ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD. Hengdian CN
01 6Ofloxacin
02 1Ofloxacin, Process H
01 2China
02 1India
03 1Japan
04 1Spain
05 2U.S.A
01 1Expired
02 4Valid
03 2Withdrawn by Holder
Certificate Number : R0-CEP 2001-436 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2005-03-24
Type : Chemical
Substance Number : 1455
Certificate Number : R0-CEP 2002-029 - Rev 01
Status : Expired
Issue Date : 2004-10-13
Type : Chemical
Substance Number : 1455
Certificate Number : CEP 2003-210 - Rev 04
Status : Valid
Issue Date : 2024-12-20
Type : Chemical
Substance Number : 1455
Certificate Number : CEP 2000-134 - Rev 07
Status : Valid
Issue Date : 2023-10-11
Type : Chemical
Substance Number : 1455
Certificate Number : CEP 2000-106 - Rev 09
Status : Valid
Issue Date : 2024-02-28
Type : Chemical
Substance Number : 1455
Certificate Number : CEP 2021-213 - Rev 01
Status : Valid
Issue Date : 2023-10-06
Type : Chemical
Substance Number : 1455
Certificate Number : R1-CEP 2002-146 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2011-02-07
Type : Chemical
Substance Number : 1455
A Ofloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ofloxacin, including repackagers and relabelers. The FDA regulates Ofloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ofloxacin 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 Ofloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ofloxacin supplier is an individual or a company that provides Ofloxacin active pharmaceutical ingredient (API) or Ofloxacin finished formulations upon request. The Ofloxacin suppliers may include Ofloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Ofloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ofloxacin CEP of the European Pharmacopoeia monograph is often referred to as a Ofloxacin Certificate of Suitability (COS). The purpose of a Ofloxacin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ofloxacin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ofloxacin to their clients by showing that a Ofloxacin CEP has been issued for it. The manufacturer submits a Ofloxacin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ofloxacin CEP holder for the record. Additionally, the data presented in the Ofloxacin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ofloxacin DMF.
A Ofloxacin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ofloxacin 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 Ofloxacin suppliers with CEP (COS) on PharmaCompass.
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