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Status : Withdrawn by Holder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 10
Status : Valid
Issue Date : 2025-02-17
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Status : Withdrawn by Holder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
80
PharmaCompass offers a list of Ofloxacin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ofloxacin manufacturer or Ofloxacin supplier for your needs.
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PharmaCompass also assists you with knowing the Ofloxacin API Price utilized in the formulation of products. Ofloxacin API Price is not always fixed or binding as the Ofloxacin Price is obtained through a variety of data sources. The Ofloxacin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ofus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ofus, including repackagers and relabelers. The FDA regulates Ofus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ofus 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 Ofus supplier is an individual or a company that provides Ofus active pharmaceutical ingredient (API) or Ofus finished formulations upon request. The Ofus suppliers may include Ofus API manufacturers, exporters, distributors and traders.
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A Ofus CEP of the European Pharmacopoeia monograph is often referred to as a Ofus Certificate of Suitability (COS). The purpose of a Ofus CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ofus EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ofus to their clients by showing that a Ofus CEP has been issued for it. The manufacturer submits a Ofus CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ofus CEP holder for the record. Additionally, the data presented in the Ofus CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ofus DMF.
A Ofus CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ofus 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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