Spokane, Washington, U.S.A. March 15, 2010 - Jubilant Organosys, a leading integrated pharma and life sciences company headquartered in India, announced today that two of its contract manufacturing facilities in North America successfully completed regulatory authority cGMP audits, recently. HollisterStier Contract Manufacturing, based in Spokane Washington, U.S.A, completed a successful audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) for the review of a sterile injectable client product. Draxis Pharma, based in Montreal, Quebec, Canada, also completed a successful audit by the US Food and Drug Administration (FDA) and Health Canada.
The audit by the Japanese Pharmaceutical and Medical Device Agency (PMDA) revealed no significant observations, which has resulted in a recommendation to the MHLW that Hollister-Stier be listed as an approved manufacturing site for the client's product. Independent of the PMDA audit, the HollisterStier facility was also recently approved by the European Medicines Agency (EMA) as a manufacturing site for this same product.
The audit of Draxis Pharma by the US Food and Drug Administration (FDA) included a comprehensive cGMP review of both sterile parenteral and non-sterile semi-solid manufacturing capabilities and a Pre-Approval Inspection for three client products. No observations were received from this audit. Recommendations for site approvals for the three new client products are expected. The audit of Draxis Pharma by Health Canada focused on a cGMP review of a dedicated packaging capability and revealed no significant audit observations.
Marcelo Morales, CEO of HollisterStier Contract Manufacturing and Draxis Pharma, said "We are extremely pleased with the audit findings at both our HollisterStier and Draxis Pharma facilities. Maintaining a rigorous quality culture and robust quality systems, combined with effectively managing our clients' projects, assures the success of these projects in the global market place."
About Jubilant Organosys
Jubilant Organosys Ltd., an integrated pharmaceutical industry player, is the largest custom research and manufacturing services (CRAMS) out of India. The company has a presence across the pharmaceutical value chain for providing products and services such as proprietary products, exclusive synthesis, active pharmaceutical ingredients, contract manufacturing of sterile injectables & non-sterile products, radiopharmaceuticals, generic dosage forms, drug discovery services, medicinal chemistry services, clinical research services, Life Science Chemicals, Nutrition Ingredients and Health Care. The Company also manufactures Agri and Performance Polymer products. For more information please visit:
About HollisterStier Contract Manufacturing and DRAXIS Pharma
HollisterStier Contract Manufacturing and DRAXIS Pharma are separately branded contract manufacturing organizations that joined capabilities and services under the ownership of Jubilant Organosys. HollisterStier is a global manufacturing service provider, able to aseptically fill liquid and lyophilized products at their Spokane, Washington, U.S.A., facility and DRAXIS Pharma offers manufacturing services for sterile liquid and sterile and non-sterile semi-solid dosage forms at their Montreal, Quebec, Canada, facility. Manufacturing facilities for solid dosage forms are also available in the United States and India through HollisterStier and DRAXIS. Both organizations offer highly-skilled, cross-functional teams to provide custom solutions to customer-specific project goals from development through commercialization. HollisterStier and DRAXIS are committed to providing exceptional quality, regulatory expertise and operational excellence to ensure streamlined processes and services in all facilities. For more information about HollisterStier Contract Manufacturing, please visit HScontract.com and for more information about DRAXIS Pharma, visit DRAXISPharma.com.
Statements in this document relating to future status, events, or circumstances, including but not limited to statements about plans and objectives, the progress and results of research and development, potential product characteristics and uses, product sales potential and target dates for product launch are forward-looking statements based on estimates and the anticipated effects of future events on current and developing circumstances. Such statements are subject to numerous risks and uncertainties and are not necessarily predictive of future results. Actual results may differ materially from those anticipated in the forward-looking statements. Jubilant Organosys and its subsidiaries may, from time to time, make additional written and oral forward looking statements, including statements contained in the Company's filings with the regulatory bodies and its reports to shareholders. The Company assumes no obligation to update forward-looking statements to reflect actual results, changed assumptions or other factors.