About us ...

From our site in Charles City, Iowa, USA, we develop and manufacture small molecule APIs, fine chemicals and intermediates for a wide range of applications.

Home to a team of more than 350 employees, the site is comprised of four large scale commercial cGMP production plants, as well as a cGMP pilot plant and cGMP kilo laboratory.

From our Charles City facility, we currently produce more than 40 APIs per year across our multi-purpose production units. Our site is also equipped to handle controlled substances, with potent compound development, manufacturing, drying and packaging capabilities. The facility is one of a limited number to be authorized by the Drug Enforcement Administration (DEA) to import narcotic raw materials at commercial scale.

EU CEP's List:

Substance  Certificate Holder Certificate Number Issue
Date
Status End date Type
2016 Ondansetron hydrochloride dihydrate Cambrex Charles City, Inc. US 50616 Charles City   R1-CEP 2003-130-Rev 01 12/12/2011 VALID   Chemistry
1792 Nicotine resinate Nicotine content 20% Cambrex Charles City, Inc. US 50616 Charles City   R1-CEP 2008-171-Rev 01 05/02/2015 VALID   Chemistry
863 Sulfasalazine Cambrex Charles City, Inc. US 50616 Charles City   R1-CEP 1996-040-Rev 02 30/08/2007 VALID   Chemistry
1455 Ofloxacin Cambrex Charles City, Inc. US 50616 Charles City   R0-CEP 2002-029-Rev 01 13/10/2004 EXPIRED 04/11/2008 Chemistry
727 Lidocaine Cambrex, Karlskoga AB SE 69185 Karlskoga   R1-CEP 2011-326-Rev 00 17/05/2018 VALID   Chemistry
1699 Mesalazine Grade S Cambrex, Karlskoga AB SE 69185 Karlskoga   R1-CEP 2003-071-Rev 02 22/04/2013 VALID   Chemistry
2132 Torasemide Cambrex Charles City, Inc. US 50616 Charles City   R1-CEP 2005-111-Rev 00 17/02/2012 VALID   Chemistry
2303 Adrenaline Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R0-CEP 2013-266-Rev 02 09/03/2018 VALID   Chemistry
1103 Fentanyl citrate Cambrex Charles City, Inc. US 50616 Charles City   R1-CEP 2006-288-Rev 00 01/08/2014 VALID   Chemistry
2630 Rivastigmine hydrogen tartrate Cambrex, Karlskoga AB SE 69185 Karlskoga   R0-CEP 2014-292-Rev 00 16/06/2016 VALID   Chemistry
254 Adrenaline tartrate Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R0-CEP 2013-221-Rev 02 09/03/2018 VALID   Chemistry
803 Amiodarone hydrochloride Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2005-127-Rev 02 04/04/2017 VALID   Chemistry
1699 Mesalazine Grade SH Cambrex, Karlskoga AB SE 69185 Karlskoga   R1-CEP 2004-093-Rev 02 22/04/2013 VALID   Chemistry
936 Midazolam Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2006-025-Rev 03 28/07/2017 VALID   Chemistry
1210 Fentanyl Cambrex Charles City, Inc. US 50616 Charles City   R1-CEP 2004-288-Rev 01 30/05/2013 VALID   Chemistry
704 Benzoyl Peroxide, Hydrous Cambrex, Karlskoga AB SE 69185 Karlskoga   R1-CEP 2009-118-Rev 01 08/06/2017 VALID   Chemistry
394 Hydrochlorothiazide Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2004-307-Rev 04 07/03/2017 VALID   Chemistry
1792 Nicotine resinate Nicotine content 15% Cambrex Charles City, Inc. US 50616 Charles City   R1-CEP 2008-089-Rev 01 26/02/2015 VALID   Chemistry
285 Noradrenaline tartrate Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2009-006-Rev 01 21/02/2018 VALID   Chemistry
562 Sodium cromoglicate Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2006-055-Rev 01 20/03/2017 VALID   Chemistry
1121 Lorazepam Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2008-049-Rev 01 03/05/2018 VALID   Chemistry
1191 Clozapine Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2005-128-Rev 02 11/06/2018 VALID   Chemistry
2629 Rivastigmine Cambrex, Karlskoga AB SE 69185 Karlskoga   R0-CEP 2014-291-Rev 01 10/05/2017 VALID   Chemistry
541 Bupivacaine hydrochloride Cambrex, Karlskoga AB SE 69185 Karlskoga   R1-CEP 2011-254-Rev 00 31/01/2019 VALID   Chemistry
879 Bromazepam Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2008-318-Rev 01 20/12/2017 VALID   Chemistry
227 Lidocaine hydrochloride monohydrate Cambrex, Karlskoga AB SE 69185 Karlskoga   R1-CEP 2011-325-Rev 01 12/02/2018 VALID   Chemistry
1280 Zolpidem tartrate Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo   R1-CEP 2005-035-Rev 03 27/03/2019 VALID   Chemistry
 
 

Activities ...

  • Contract Manufacturing
 
 

Services and Products ...

  • Active Pharmaceutical Ingredients
  • High Potency API's
  • Small Molecule Synthesis
  • Containment Facilities
  • Controlled Status Products
 
  • Narcotics
  • Analytical Services
  • Analytical Method Development & Validation
  • Oligonucleotides
 

Certifications ...

  • GMP- as per ICH Q7a
  • GMP-USA-FDA-Inspected
 
  • USA-DEA-Schedule I-IV
 
 
 
 
 
 
 
 

About Us

SURIMS is the new name for Actex Pharma Services which was a consultancy established in 2003, supporting companies in the identification, qualification and management of quality vendors and suppliers in ingredients and formulations.

The Pharmaceutical Services Directory supports the identification and on-boarding of quality suppliers and also incorporates software features that manage relationships between suppliers and their customers. These include the building and deployment of questionnaires and assessments, electronic signatures and sign-offs and project management between vendor/partner and customer.

Access to the features and software is available on a 'pay as you go' basis, or a customised version can be licensed for your company for its own supplier on-boarding and supplier management activities. Further information on our software services please contact Tel: +353 87 294 0436 or email info@pharmaservicesdirectory.com

 
 
 

Get in Touch

The Pharmaceutical Services Directory
info@pharmaservicesdirectory.com.

 
 

© 2019 Actex Pharma Services | All Rights Reserved.