Aspen API. More than just an API.
01 1Fine Chemicals Corporation (Pty) Ltd. Cape Town ZA
02 1Johnson Matthey Pharmaceutical Materials West Deptford US
03 1MACFARLAN SMITH LIMITED Edinburgh GB
04 1Rusan Pharma Ltd. Mumbai IN
05 1AREVIPHARMA GMBH Radebeul DE
06 1CAMBREX CHARLES CITY, INC. Charles City US
07 1CURIA WISCONSIN, INC. Grafton US
08 1JANSSEN PHARMACEUTICA NV Beerse BE
09 1Kern Pharma, S.L. Terrassa ES
10 1N.V. ORGANON Oss NL
11 1RUSAN PHARMA LTD Mumbai IN
12 1SPECGX LLC Webster Groves US
13 1YICHANG HUMANWELL PHARMACEUTICAL CO., LTD. Yichang CN
01 13Fentanyl
01 1Belgium
02 1China
03 1Germany
04 2India
05 1Ireland
06 1South Africa
07 1Spain
08 4U.S.A
09 1United Kingdom
01 11Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
Certificate Number : R1-CEP 2005-233 - Rev 03
Status : Valid
Issue Date : 2018-10-04
Type : Chemical
Substance Number : 1210
Certificate Number : R1-CEP 2000-141 - Rev 03
Status : Valid
Issue Date : 2013-03-04
Type : Chemical
Substance Number : 1210
Certificate Number : R1-CEP 2016-018 - Rev 00
Status : Valid
Issue Date : 2022-05-20
Type : Chemical
Substance Number : 1210
Certificate Number : R1-CEP 2007-158 - Rev 01
Status : Valid
Issue Date : 2014-10-14
Type : Chemical
Substance Number : 1210
Certificate Number : R1-CEP 2004-288 - Rev 03
Status : Valid
Issue Date : 2020-05-25
Type : Chemical
Substance Number : 1210
Certificate Number : R1-CEP 2005-044 - Rev 03
Status : Valid
Issue Date : 2021-08-27
Type : Chemical
Substance Number : 1210
Certificate Number : R1-CEP 1998-044 - Rev 03
Status : Valid
Issue Date : 2018-01-18
Type : Chemical
Substance Number : 1210
Certificate Number : R1-CEP 2008-136 - Rev 00
Status : Valid
Issue Date : 2014-07-22
Type : Chemical
Substance Number : 1210
Certificate Number : CEP 2005-260 - Rev 03
Status : Valid
Issue Date : 2024-02-14
Type : Chemical
Substance Number : 1210
Certificate Number : R0-CEP 2021-136 - Rev 00
Status : Valid
Issue Date : 2022-06-30
Type : Chemical
Substance Number : 1210
A Fentanyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fentanyl, including repackagers and relabelers. The FDA regulates Fentanyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fentanyl 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 Fentanyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fentanyl supplier is an individual or a company that provides Fentanyl active pharmaceutical ingredient (API) or Fentanyl finished formulations upon request. The Fentanyl suppliers may include Fentanyl API manufacturers, exporters, distributors and traders.
click here to find a list of Fentanyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fentanyl CEP of the European Pharmacopoeia monograph is often referred to as a Fentanyl Certificate of Suitability (COS). The purpose of a Fentanyl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fentanyl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fentanyl to their clients by showing that a Fentanyl CEP has been issued for it. The manufacturer submits a Fentanyl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fentanyl CEP holder for the record. Additionally, the data presented in the Fentanyl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fentanyl DMF.
A Fentanyl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fentanyl 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 Fentanyl suppliers with CEP (COS) on PharmaCompass.
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