Custom Synthesis and cGMP Profile Sheet - Strem Chemicals
Chemicals, Inc. Metals
Inorganics
Organometallics
Catalysts
Ligands
Corporate Headquarters, Newburyport, MA, USA
Nanomaterials
Custom Synthesis
cGMP
cGMP kilo-lab manufacturing suites
Custom Synthesis and cGMP Production Custom synthesis services and process development are conducted under the strictest confidence. A broad range of chemical transformations are possible at Strem’s facility. For pharmaceutical applications, manufacturing is conducted under current Good Manufacturing Practices (cGMP) in kilo-lab suites. This capability has been available at the Newburyport headquarters since 1988. Complete documentation is provided, including validation and stability studies. Both Active Pharmaceutical Ingredients (APIs) and late stage raw materials for APIs are manufactured. Active Drug Master Files (DMF’s) are also maintained in North America and Europe. Quality agreements are in place with major US and International drug companies.
Strem’s cGMP facilities were most recently inspected by the FDA in 2016. Regulatory Filings* Cisplatin • • • • • • • • •
US FDA DMF #7017 15 June 1987 France EDMF Reference Number 2004-006, 18 March, 2004 Germany EDMF Reference Number 11.02-3620-629 23 December, 2007 Czech Republic EDMF Reference Number 4309STREM1105A04 December, 2007 Austria EDMF ASMF07263; December, 2007 Belgium EDMF 2007-1328; December, 2007 Spain EDMF 237/2007 December, 2007 Italy EDMF AIN/2007/5202 December, 2007 EDMF have also been filed in 2007 in Cyprus, Estonia, France, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, UK
Carboplatin • • • • • • •
US Drug Master File 15938, 11 April 2002 European Certificate of Suitability Reference Number R1-CEP 2002-129-Rev 01, 17 January, 2008 Australia Drug Master File 2003/18057, 7 May, 2003 Belgium Drug Master File 671, 12 March 2002 Norway Drug Master File 03-2687, 14 March 2003 Luxembourg Drug Master File (11/2005) 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, Sweden
Pamidronic Acid • • •
FDA DMF #12803 22 December 1997 Canada Drug Master File 2001-007, updated February, 2007 Australia Drug Master File 2007/8380, August 2007
Fomepizole •
FDA DMF #19978, 13 December, 2006
Dexmedetomidine Hydrochloride •
US Drug Master file 24202, 15 December 2011 (Administered by Strem’s partner)
*Many other products have been manufactured under cGMP with no official regulatory filing Strem Chemicals is a member of SOCMA (Society of Chemical Manufacturers and Affiliates) and is committed to the ChemStewards® program.
Strem Chemicals, Inc. 7 Mulliken Way Newburyport, MA 01950 U.S.A Tel: 978.499.1600 Fax: 978.465.3104 Email: [email protected]
Strem Chemicals, Inc. 15, rue de l’Atome Zone Industrielle 67800 BISCHHEIM France Tel: (33) 03 88 62 52 60 Fax: (33) 03 88 62 26 81 Email: [email protected]
Strem Chemicals, Inc. Postfach 1215 77672 KEHL Germany Tel: 0 78 51/ 7 58 79 Email: [email protected]
Strem Chemicals UK Ltd.
An Independent Distributor of Strem Chemicals Products
Newton Hall, Town Street Newton, Cambridge England CB22 7ZE Tel: 0845 643 7263 Fax:0845 643 7362 Email: [email protected]
Inorganics
Organometallics
Catalysts
Ligands
Corporate Headquarters, Newburyport, MA, USA
Nanomaterials
Custom Synthesis
cGMP
cGMP kilo-lab manufacturing suites
Custom Synthesis and cGMP Production Custom synthesis services and process development are conducted under the strictest confidence. A broad range of chemical transformations are possible at Strem’s facility. For pharmaceutical applications, manufacturing is conducted under current Good Manufacturing Practices (cGMP) in kilo-lab suites. This capability has been available at the Newburyport headquarters since 1988. Complete documentation is provided, including validation and stability studies. Both Active Pharmaceutical Ingredients (APIs) and late stage raw materials for APIs are manufactured. Active Drug Master Files (DMF’s) are also maintained in North America and Europe. Quality agreements are in place with major US and International drug companies.
Strem’s cGMP facilities were most recently inspected by the FDA in 2016. Regulatory Filings* Cisplatin • • • • • • • • •
US FDA DMF #7017 15 June 1987 France EDMF Reference Number 2004-006, 18 March, 2004 Germany EDMF Reference Number 11.02-3620-629 23 December, 2007 Czech Republic EDMF Reference Number 4309STREM1105A04 December, 2007 Austria EDMF ASMF07263; December, 2007 Belgium EDMF 2007-1328; December, 2007 Spain EDMF 237/2007 December, 2007 Italy EDMF AIN/2007/5202 December, 2007 EDMF have also been filed in 2007 in Cyprus, Estonia, France, Greece, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, UK
Carboplatin • • • • • • •
US Drug Master File 15938, 11 April 2002 European Certificate of Suitability Reference Number R1-CEP 2002-129-Rev 01, 17 January, 2008 Australia Drug Master File 2003/18057, 7 May, 2003 Belgium Drug Master File 671, 12 March 2002 Norway Drug Master File 03-2687, 14 March 2003 Luxembourg Drug Master File (11/2005) 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, Sweden
Pamidronic Acid • • •
FDA DMF #12803 22 December 1997 Canada Drug Master File 2001-007, updated February, 2007 Australia Drug Master File 2007/8380, August 2007
Fomepizole •
FDA DMF #19978, 13 December, 2006
Dexmedetomidine Hydrochloride •
US Drug Master file 24202, 15 December 2011 (Administered by Strem’s partner)
*Many other products have been manufactured under cGMP with no official regulatory filing Strem Chemicals is a member of SOCMA (Society of Chemical Manufacturers and Affiliates) and is committed to the ChemStewards® program.
Strem Chemicals, Inc. 7 Mulliken Way Newburyport, MA 01950 U.S.A Tel: 978.499.1600 Fax: 978.465.3104 Email: [email protected]
Strem Chemicals, Inc. 15, rue de l’Atome Zone Industrielle 67800 BISCHHEIM France Tel: (33) 03 88 62 52 60 Fax: (33) 03 88 62 26 81 Email: [email protected]
Strem Chemicals, Inc. Postfach 1215 77672 KEHL Germany Tel: 0 78 51/ 7 58 79 Email: [email protected]
Strem Chemicals UK Ltd.
An Independent Distributor of Strem Chemicals Products
Newton Hall, Town Street Newton, Cambridge England CB22 7ZE Tel: 0845 643 7263 Fax:0845 643 7362 Email: [email protected]
