01 1ACS DOBFAR S.P.A. Tribiano IT
02 1ANTIBIOTICOS DO BRASIL LTDA. Cosmopolis BR
03 1AUROBINDO PHARMA LIMITED Hyderabad IN
04 2FRESENIUS KABI IPSUM S.R.L. Cassina de’ Pecchi IT
05 1GlaxoSmithKline Research & Development Limited London GB
06 2HANMI FINE CHEMICAL CO., LTD. Siheung-si KR
07 1KYONGBO PHARMACEUTICAL CO., LTD. Asan-si KR
08 1NECTAR LIFESCIENCES LIMITED Tehsil Dera Bassi IN
09 2ORCHID PHARMA LIMITED Alathur IN
10 2Qilu Antibiotics Pharmaceutical Co., Ltd. Jinan CN
11 2SANDOZ GMBH Kundl AT
01 1Ceftazidime Pentahydrate
02 8Ceftazidime Pentahydrate, Sterile
03 7Ceftazidime pentahydrate with sodium carbonate for injection, Sterile
01 1Brazil
02 2China
03 2Germany
04 4India
05 3Italy
06 3South Korea
07 1United Kingdom
01 14Valid
02 2Withdrawn by Holder
Ceftazidime Pentahydrate, Sterile
Certificate Number : CEP 2023-299 - Rev 00
Status : Valid
Issue Date : 2024-07-29
Type : Chemical
Substance Number : 1405
Ceftazidime Pentahydrate With Sodium Carbonate F...
Certificate Number : CEP 2010-026 - Rev 03
Status : Valid
Issue Date : 2024-04-15
Type : Chemical
Substance Number : 2344
Ceftazidime Pentahydrate, Sterile
Certificate Number : R1-CEP 2002-069 - Rev 07
Status : Valid
Issue Date : 2023-06-14
Type : Chemical
Substance Number : 1405
Ceftazidime Pentahydrate With Sodium Carbonate F...
Certificate Number : R0-CEP 2019-231 - Rev 01
Status : Valid
Issue Date : 2021-11-15
Type : Chemical
Substance Number : 2344
Ceftazidime Pentahydrate, Sterile
Certificate Number : CEP 2005-028 - Rev 05
Status : Valid
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 1405
Ceftazidime Pentahydrate With Sodium Carbonate F...
Certificate Number : CEP 2009-234 - Rev 01
Status : Valid
Issue Date : 2024-09-09
Type : Chemical
Substance Number : 2344
Ceftazidime Pentahydrate With Sodium Carbonate F...
Certificate Number : R1-CEP 2010-125 - Rev 03
Status : Valid
Issue Date : 2021-01-06
Type : Chemical
Substance Number : 2344
Ceftazidime Pentahydrate, Sterile
Certificate Number : R1-CEP 2016-195 - Rev 00
Status : Valid
Issue Date : 2022-11-10
Type : Chemical
Substance Number : 1405
Ceftazidime Pentahydrate, Sterile
Certificate Number : R1-CEP 2001-252 - Rev 04
Status : Valid
Issue Date : 2015-06-15
Type : Chemical
Substance Number : 1405
Ceftazidime Pentahydrate With Sodium Carbonate F...
Certificate Number : R1-CEP 2010-272 - Rev 01
Status : Valid
Issue Date : 2019-05-03
Type : Chemical
Substance Number : 2344
A AVYCAZ manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AVYCAZ, including repackagers and relabelers. The FDA regulates AVYCAZ manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AVYCAZ 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 AVYCAZ supplier is an individual or a company that provides AVYCAZ active pharmaceutical ingredient (API) or AVYCAZ finished formulations upon request. The AVYCAZ suppliers may include AVYCAZ API manufacturers, exporters, distributors and traders.
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A AVYCAZ CEP of the European Pharmacopoeia monograph is often referred to as a AVYCAZ Certificate of Suitability (COS). The purpose of a AVYCAZ CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AVYCAZ EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AVYCAZ to their clients by showing that a AVYCAZ CEP has been issued for it. The manufacturer submits a AVYCAZ CEP (COS) as part of the market authorization procedure, and it takes on the role of a AVYCAZ CEP holder for the record. Additionally, the data presented in the AVYCAZ CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AVYCAZ DMF.
A AVYCAZ CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AVYCAZ 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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