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Formulations and clinical trial materials lead Piramal’s new Ahmedabad facility27 January 2009 Piramal Pharma Solutions (Informex Booth 1220) is on schedule to commission a new state of the art formulations development and clinical trial materials (CTM) supply centre at Ahmedabad, India. The centre will have GMP supply capabilities from March onwards. The development is the latest in a series – involving both European and Indian assets - taking Piramal deeper into the clinical trials space. Located in Ahmedabad’s Special Export Promotion (SEZ) Zone, the centre has a total footprint of 50,000 sq. ft. - of which only half will be built out in Phase I. Initially, over 34 formulators and 48 analytical chemists will be based at the centre - with plans to increase to a total of 180 over two phases. The facility will provide the full suite of services including formulations development, analytical development and validation, CTM supply, exhibit batches and ICH stability studies. Three-shift operation will speed project throughput, while SEZ status will give pricing benefits to customers. The centre is equipped with state of the art, instrumented equipment for early phase solids formulations development and CTM supply. Assets include Glatt FBPs, Roller Compactors, Korsch compression machines and encapsulation machines. Ten GMP suites with dedicated air handling units will allow the team to work simultaneously on several projects. Separate suites are being built out with “Low RH” capability as well as ability to handle high potency actives. The Ahmedabad centre can handle projects from Ph I – Ph III supply requirements and dovetails perfectly with the company’s USFDA approved Pithampur site, which can carry out launch/commercial supply of finished dosage form. “The latest development in Ahmedabad signals the continuing upgrade in our clinical trials manufacturing and services capabilities”, commented Dr. R. Ananthanarayanan, President& Head for Piramal Pharma Solutions. “The programme marks further expansion of our synthesis-to-market supply chain, with further elements due for announcement later this year”, he added. The development is the third in a sequence: at CPhI last autumn the company announced creation in Morpeth UK of a new 13,000 sq. ft. clinical trials packaging and distribution facility. It also highlit the launch of Piramal Clinical Research (PCR) via the acquisition of Romania’s niche clinical trials management company Tangent Data s.r.l. Over the next three years, Piramal envisages the spread of PCR in Western and Eastern Europe, across South Asia and into North America. With annual revenues exceeding US $325m., Piramal Healthcare’s Pharma Solutions custom manufacturing business is one of the world’s top 10 pharma contract manufacturers. The business is one of the very few leading global custom manufacturing organisations offering a complete service spanning the full drug lifecycle – from early phase synthesis to commercial manufacture and commercial market supply in final dosage form. Notes for Editors: For further information contact: Vijay Sathye Roger Johnstone
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