01 1AKUMS LIFESCIENCES LIMITED Mohali District IN
02 2APITORIA PHARMA PRIVATE LIMITED Hyderabad IN
03 2ASTELLAS PHARMA INC. Tokyo JP
04 1COVALENT LABORATORIES PRIVATE LIMITED Hyderabad IN
05 1DHANUKA LABORATORIES LTD. Gurgaon IN
06 1HANMI FINE CHEMICAL CO., LTD. Siheung-si KR
07 1KYONGBO PHARMACEUTICAL CO., LTD. Asan-si KR
08 1LUPIN LIMITED Mumbai IN
09 2NECTAR LIFESCIENCES LIMITED Tehsil Dera Bassi IN
10 1ORCHID PHARMA LIMITED Alathur IN
11 2Qilu Antibiotics Pharmaceutical Co., Ltd. Jinan CN
12 1SANDOZ GMBH Kundl AT
13 2SANDOZ PRIVATE LIMITED Navi Mumbai IN
14 1SURYA PHARMACEUTICAL LTD. Chandigarh IN
15 1UNIMARK REMEDIES LIMITED Mumbai IN
16 1ZHEJIANG APELOA TOSPO PHARMACEUTICAL CO., LTD. Dongyang City CN
01 17Cefixime
02 1Cefixime, Alternative process
03 2Cefixime, Process 2
04 1Cefixime, Process II
01 3China
02 3Germany
03 11India
04 2Japan
05 2South Korea
01 12Valid
02 3Withdrawn by EDQM Failure to CEP procedure
03 6Withdrawn by Holder
Certificate Number : R1-CEP 2009-005 - Rev 01
Status : Valid
Issue Date : 2022-01-13
Type : Chemical
Substance Number : 1188
Certificate Number : CEP 2007-055 - Rev 03
Status : Valid
Issue Date : 2023-12-13
Type : Chemical
Substance Number : 1188
Certificate Number : CEP 2023-014 - Rev 00
Status : Valid
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 1188
Certificate Number : R1-CEP 2002-155 - Rev 06
Status : Valid
Issue Date : 2019-07-02
Type : Chemical
Substance Number : 1188
Certificate Number : R1-CEP 2011-239 - Rev 00
Status : Valid
Issue Date : 2019-03-08
Type : Chemical
Substance Number : 1188
Certificate Number : R1-CEP 2017-042 - Rev 00
Status : Valid
Issue Date : 2022-05-23
Type : Chemical
Substance Number : 1188
Certificate Number : CEP 2002-125 - Rev 03
Status : Valid
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 1188
Certificate Number : R1-CEP 2014-213 - Rev 00
Status : Valid
Issue Date : 2021-02-19
Type : Chemical
Substance Number : 1188
Certificate Number : R0-CEP 2021-361 - Rev 00
Status : Valid
Issue Date : 2021-12-09
Type : Chemical
Substance Number : 1188
Certificate Number : CEP 2019-162 - Rev 01
Status : Valid
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 1188
A Oroken manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oroken, including repackagers and relabelers. The FDA regulates Oroken manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oroken 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 Oroken manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oroken supplier is an individual or a company that provides Oroken active pharmaceutical ingredient (API) or Oroken finished formulations upon request. The Oroken suppliers may include Oroken API manufacturers, exporters, distributors and traders.
click here to find a list of Oroken suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oroken CEP of the European Pharmacopoeia monograph is often referred to as a Oroken Certificate of Suitability (COS). The purpose of a Oroken CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oroken EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oroken to their clients by showing that a Oroken CEP has been issued for it. The manufacturer submits a Oroken CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oroken CEP holder for the record. Additionally, the data presented in the Oroken CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oroken DMF.
A Oroken CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oroken 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 Oroken suppliers with CEP (COS) on PharmaCompass.
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