PolyPeptide Group, a world leader in the industrial/commercial-scale manufacture of proprietary and generic GMP and non-GMP peptides, has opened its first GMP peptide manufacturing facility in India. The facility is located in Ambernath, approximately 55 kilometers away from Mumbai. The facility was inaugurated by Frederik Paulsen, Group chairman on December 11, 2009.

This site is built as a greenfield facility at Additional MIDC Ambernath on a 6 acre site, with its own utility plant, which is designed to accommodate three production buildings. At present one of the three production buildings is ready. Its total area is 3100 sq meters. It accommodates manufacturing space with administration office and laboratory facilities. Investment cost of the facility has not been disclosed.

The state-of-the-art facility, which is fully equipped, planned to be operational according to US FDA and other global regulatory agency standards by Q1 2010. The facility will operate in strict compliance with the environmental laws prevailing in India. It will be primarily operated as a production unit supported by QA, QC, regulatory resources and microbiology laboratory. It has the capacity to produce 100s kgs of peptides per year.

The facility will initially employ mainly solid phase peptide synthesis (SPPS) technology, and later on plans to add liquid (solution) phase peptide synthesis (LPPS) capacity. Initially, the group plans to manufacture four products. “We would start manufacturing generic peptide at initial stage. Generic peptides are used as API. The peptide which produced by us are specialised and concentrated. We are looking forward to market our product for Indian generic markets but as of now we have our clients in Europe and US. The products would be exported from here,” Dr Jane Salik, the group’s CEO informed.

Dr Salik said, “The reason why we set up the facility in India is because of accessibility of well-educated and highly professional staff.”

The India facility is managed by Dr Shreerang Joshi as managing director and Dr Vivek Khare as director of Operations. Incidentally, both Dr Joshi and Dr Khare are alumni of UDCT and CSIR.