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Jubilant Roorkee excels in tender production
Operationally, 2008 respresented a year of strong growth for Jubilant. In the finished dosage forms field, the inauguration of the newly constructed dosage forms plant in Roorkee, marked a significant milestone and completed the last step towards total backward integration from API development to the production of finished dosage forms.
After obtaining EU-GMP approval in record time, the facility attained a next success in supplies for its first tender production. Backed by competitive costing, Jubilant’s customer was awarded a tender with high volume requirements on long term and an immediate stock requirement upon being awarded the tender.
Jubilant Roorkee has successfully managed the volume requirements against a rigid time schedule. The facility has excelled in meeting deadline after deadline through efficient planning without any compromise on the high quality standards.
The Roorkee facility caters to supplies of Jubilant’s dosage form developments for the European market with current production capacities spanning across various IR, NDDS and taste-masked oral solids.
Olanzapine registrations through DCP
Following the registration of the several dosage form products across Europe in 2008, marketing authorization applications will be run for 15 generic dossiers during 2009.
January 2009 marked the start of the Decentralized registration procedure (DCP) for Olanzapine filmcoated tablets, while the DCP slot for Olanzapine oral dispersible tablets has been fixed for April 2009. Additional countries/ partners can still be included in this DCP procedure and details regarding the product registrations for 2009 can be obtained upon request.
Contact sales@jubilant.be for further information.
Jubilant’s R&D in generic dosage forms has delivered consistently by creating a stable and consistent model for growth. Therapeutic categories in focus are the central nervous system, cardiovascular system, anti-infective, respiratory and anti-diabetics. Over 60 projects in various stages of development are handled simultaneously while identification of new projects for development is a constant process.
The development portfolio for generic dosage forms has been firmed up for the next years and DCP slots have been fixed for 20 products.
An overview of selected products can be found on our website www.jubilant.be/portfolio.php.
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