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'Product Blog'

Manufacture of Active Pharmaceutical Ingredients (API) at Strem Chemicals

API’s Manufactured Under FDA Regulatory Compliance by cGMP Protocol According to ICH Q7 with Submission of Chemistry, Manufacturing, and Controls Documentation and Drug Master Files to Support ANDA Approvals

For pharmaceutical applications, manufacturing of API's (active pharmaceutical ingredients) and critical intermediates are conducted under current Good Manufacturing Practices (cGMP) in our kilo–lab facility (class 10,000), which has been operational since 1988. Strem can optimize a synthetic route to an API that meets strict purity and process control requirements.  We also can develop, validate, and justify process and release test methods, complete and evaluate degradation and stability studies, and develop a complete Chemistry, Manufacturing, and Controls documentation package for submission to the FDA within a drug mater file.

Strem operates under a cGMP compliant quality management system compliant to ICH Q7.  We are inspected by several customers each year and by the FDA approximately bi-annually.  Our customers include both small and large, domestic and international drug companies. We are currently expanding our internal analytical test facilities.  Strem works closely with customers to achieve regulatory approvals and maintain a product in a state of validation throughout its lifecycle.

The Newburyport facility was last inspected by the Food and Drug Administration in 2014.

Below is a list of Strem’s Regulatory Filings:


  1.        US FDA DMF #7017 15 June 1987
  2.        France EDMF Reference Number 2004–006, 18 March, 2004
  3.        Germany EDMF Reference Number 11.02–3620–629 23 December, 2007
  4.        Czech Republic EDMF Reference Number 4309STREM1105A04 December, 2007
  5.        Austria EDMF ASMF07263; December, 2007
  6.        Belgium EDMF 2007–1328; December, 2007
  7.        Spain EDMF 237/2007 December, 2007
  8.        Italy EDMF AIN/2007/5202 December, 2007
  9.        EDMF have also been filed in 2007 in Cyprus, Estonia, France, Greece, Ireland, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, UK


  1.    US Drug Master File 15938, 11 April 2002
  2.    European Certificate of Suitability Reference Number R1–CEP 2002–129–Rev 01, 18 January, 2008
  3.    Australia Drug Master File 2003/18057, 7 May, 2003
  4.    Belgium Drug Master File 671, 12 March 2002
  5.    Norway Drug Master File 03–2687, 14 March 2003
  6.    Luxembourg Drug Master File (11/2005)
  7.    Unregistered filings of the Applicants part have been submitted on 2/5/2003 to Denmark, England, Finland, France, Greece, Ireland, Italy, The Netherlands, Portugal, Spain, and Sweden.

Pamidronic Acid

  1.    FDA DMF #12803 22 December 1997 (Administered by Strem's partner)
  2.    Canada Drug Master File 2001–007, updated February, 2007
  3.    Australia Drug Master File 2007/8380, August 2007


  1.    FDA DMF #19978, 13 December, 2006

Dexmedetomidine Hydrochloride

  1.    US Drug Master File 24202, 15 December 2011 (Administered by Strem's partner)


Visit the link below to view related up-to-date information on our website:

Custom Synthesis & cGMP


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