PolyPeptide Laboratories Builds New Facility in India
The PolyPeptide Laboratories Group, a worldwide GMP manufacturer of peptide APIs, is close to completing its new facility in India. The site will initially focus on the manufacture of generic peptides. The facility is located in Ambernath, approximately 65 kilometers (40 miles) northeast of Mumbai, and is built as a green field facility in an area controlled by the Maharashtra Industrial Development Corporation (MIDC). The self-contained, approximately 6-acre site, with its own utilities plant, is designed to accommodate three production buildings, the first of which will be similar in design to the Torrance, California site, with a total of approximately 2,500 square meters (25,000 square feet) of manufacturing space, together with office and laboratory facilities.
The state-of-the-art facility, which will be fully equipped by Q2 2008, is planned to be operational according to US FDA standards by Q3 2008 and will operate in strict compliance with the environmental laws of the state of Maharashtra and the federal government of India. It will primarily be operated as a production unit supported by QA, QC, regulatory and qualification/validation resources, as well as a microbiology laboratory, with eventual plans to institute a development group. The facility will mainly employ solid-phase peptide synthesis (SPPS), but it will also be equipped for solution-phase peptide synthesis (LPPS).
Michael Verlander, D.Phil., Executive Vice-President of Quality Assurance and Regulatory Affairs for the Group comments, "The India facility is being built from the ground up with full compliance with international GMPs in mind, and experts from all of our sister companies have been involved in the planning. Our customers can feel completely confident that a high level of compliance with GMPs will be enforced at the site, from raw material supply through QC/QA release of the finished APIs."
With peptide API requirements at an all-time high in the pharmaceutical industry, the PolyPeptide Laboratories Group has recently completed an expansion of the US facility, and expansions are still ongoing in Europe. The completed and ongoing expansions, as well as the new dedicated generics facility in India, will allow PolyPeptide Laboratories to support all peptide projects, from conception to commercialization.
For more information, please visit the PolyPeptide Laboratories website at www.PolyPeptide.com.
