Aspen API. More than just an API.
01 1Fine Chemicals Corporation (Pty) Ltd. Cape Town ZA
02 1MACFARLAN SMITH LIMITED Edinburgh GB
03 1VERANOVA, L.P. West Deptford US
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 1SANECA PHARMACEUTICALS A.S. Hlohovec SK
12 1SPECGX LLC Webster Groves US
13 1YICHANG HUMANWELL PHARMACEUTICAL CO., LTD. Yichang CN
Aspen API. More than just an API.
Certificate Number : R1-CEP 2013-071 - Rev 00
Status : Valid
Issue Date : 2019-09-04
Type : Chemical
Substance Number : 1103
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : R1-CEP 2005-104 - Rev 04
Status : Valid
Issue Date : 2023-08-30
Type : Chemical
Substance Number : 1103
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Certificate Number : R1-CEP 2016-023 - Rev 00
Status : Valid
Issue Date : 2022-05-30
Type : Chemical
Substance Number : 1103
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : R1-CEP 2000-303 - Rev 04
Status : Valid
Issue Date : 2014-10-13
Type : Chemical
Substance Number : 1103
A Fentanyl Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fentanyl Citrate, including repackagers and relabelers. The FDA regulates Fentanyl Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fentanyl Citrate 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 Fentanyl Citrate supplier is an individual or a company that provides Fentanyl Citrate active pharmaceutical ingredient (API) or Fentanyl Citrate finished formulations upon request. The Fentanyl Citrate suppliers may include Fentanyl Citrate API manufacturers, exporters, distributors and traders.
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A Fentanyl Citrate CEP of the European Pharmacopoeia monograph is often referred to as a Fentanyl Citrate Certificate of Suitability (COS). The purpose of a Fentanyl Citrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fentanyl Citrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fentanyl Citrate to their clients by showing that a Fentanyl Citrate CEP has been issued for it. The manufacturer submits a Fentanyl Citrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fentanyl Citrate CEP holder for the record. Additionally, the data presented in the Fentanyl Citrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fentanyl Citrate DMF.
A Fentanyl Citrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fentanyl Citrate 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 Citrate suppliers with CEP (COS) on PharmaCompass.
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