01 1AARTI DRUGS LIMITED Mumbai IN
02 1BAJAJ HEALTHCARE LIMITED Thane (West) IN
03 2CORDEN PHARMA BERGAMO S.P.A. Treviglio IT
04 1HEC PHARM CO Yidu CN
05 2HUBEI HONGYUAN PHARMACEUTICAL TECHNOLOGY CO., LTD. Fengshan Town CN
06 1Tianjin Zhongan Pharmaceutical Co Ltd Tianjin CN
07 1Unichem Laboratories Limited Mumbai IN
08 1Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.) Mumbai IN
09 2WUHAN WUYAO PHARMACEUTICAL CO., LTD. Huangshi City CN
01 8Metronidazole
02 2Metronidazole benzoate
03 1Metronidazole, Micronised
04 1Metronidazole, Process II
01 6China
02 4India
03 2Italy
01 7Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 4Withdrawn by Holder
Certificate Number : CEP 2023-417 - Rev 00
Status : Valid
Issue Date : 2024-09-11
Type : Chemical
Substance Number : 934
Certificate Number : R2-CEP 1995-052 - Rev 02
Status : Valid
Issue Date : 2018-04-25
Type : Chemical
Substance Number : 675
Certificate Number : R1-CEP 1996-067 - Rev 04
Status : Valid
Issue Date : 2018-05-31
Type : Chemical
Substance Number : 934
Certificate Number : CEP 2018-264 - Rev 02
Status : Valid
Issue Date : 2024-03-20
Type : Chemical
Substance Number : 675
Certificate Number : R1-CEP 2007-309 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2018-06-08
Type : Chemical
Substance Number : 675
Certificate Number : R1-CEP 1997-083 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2008-07-07
Type : Chemical
Substance Number : 675
Certificate Number : R1-CEP 2002-119 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2009-03-02
Type : Chemical
Substance Number : 675
Certificate Number : CEP 2001-450 - Rev 10
Status : Valid
Issue Date : 2024-11-05
Type : Chemical
Substance Number : 675
Certificate Number : CEP 2024-218 - Rev 00
Status : Valid
Issue Date : 2024-07-11
Type : Chemical
Substance Number : 675
Certificate Number : R1-CEP 2007-083 - Rev 05
Status : Valid
Issue Date : 2022-07-15
Type : Chemical
Substance Number : 675
A PYLERA-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PYLERA-1, including repackagers and relabelers. The FDA regulates PYLERA-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PYLERA-1 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 PYLERA-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PYLERA-1 supplier is an individual or a company that provides PYLERA-1 active pharmaceutical ingredient (API) or PYLERA-1 finished formulations upon request. The PYLERA-1 suppliers may include PYLERA-1 API manufacturers, exporters, distributors and traders.
click here to find a list of PYLERA-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PYLERA-1 CEP of the European Pharmacopoeia monograph is often referred to as a PYLERA-1 Certificate of Suitability (COS). The purpose of a PYLERA-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PYLERA-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PYLERA-1 to their clients by showing that a PYLERA-1 CEP has been issued for it. The manufacturer submits a PYLERA-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a PYLERA-1 CEP holder for the record. Additionally, the data presented in the PYLERA-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PYLERA-1 DMF.
A PYLERA-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PYLERA-1 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 PYLERA-1 suppliers with CEP (COS) on PharmaCompass.
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