13 Jun 2013, BioSpectrum Bureau , BioSpectrum
Singapore: US-based Avantor Performance Materials, a global manufacturer and supplier of high-performance chemistries and materials, has started a new production facility for producing pharmaceutical chemicals under current good manufacturing practices (cGMP) in Panoli, India.
The Panoli plant will manufacture and package a wide range of Avantor's Macron Fine Chemicals brand of salts and solvents for the production of pharmaceuticals, and high-purity solvents for use in chromatography separations for laboratory research, drug development and discovery.
Located in India's Gujarat state, the new Avantor facility is ISO 9001:2008 certified and is approved by the Indian Food and Drug Administration.
In addition to cGMP manufacturing requirements, Macron Fine Chemicals products from Panoli are produced to Indian Pharmacopeia (IP), United States Pharmacopeia (USP), National Formulary (NF), European Pharmacopeia (EP), Japanese Pharmacopeia (JP) and British Pharmacopeia (BP) standards.
"The availability of cGMP chemicals from our Panoli facility demonstrates Avantor's continued growth as a leading global manufacturer and supplier of high-quality performance materials," said Mr Paul Smaltz, Avantor's executive vice president of global pharmaceuticals.
"Our customers have said they desire a local source of raw materials that meet the global regulatory standards. This facility is an important element in Avantor's global strategy to provide our customers with what they need to have confidence in their pharmaceutical supply chain, no matter where they are located," Mr Smaltz added.
Avantor obtained the facility as part of its acquisition of RFCL Limited (now known as Avantor Performance Materials India) in 2011, when the plant was under construction. Production began in December 2012, with cGMP production commencing in January of 2013.
"The plant operates under Avantor's globally accepted quality control systems and management of change processes," said Mr Smaltz. "This is one more example to show how Avantor is committed to complete regulatory documentation in order to help customers achieve better outcomes in their product development."