Ambernath, India
PolyPeptide Laboratories is currently mid-way through the construction of its new GMP manufacturing facility in Ambernath, in the state of Maharashtra, India.
Ambernath is located approximately 65 kilometers (40 miles) northeast of Mumbai, and the site is being 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 (40,000 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).
