Teva api India Pvt. Ltd is a wholly owned subsidiary of the Teva Group, world leader in the manufacture of api's and generic pharmaceuticals. Teva api India Pvt Limited became part of Teva Group with effect from 1st August 2003
The Research and Development (R&D) unit of Teva api India Pvt Limited is located at 2G, 2H, 2I, Udyog Vihar, Greater Noida, in the state of Uttar Pradesh. The R&D Centre is spread over an area of 15,814 m² (comprising 5,002 m² of an existing structure and 10,812 m² area for future expansion) and this unit has a state-of-the-art research centre for the development of intermediates and api's, supported by very well-equipped analytical & physical laboratories with the latest & advanced instrumentation manned by professionals in the fields of science, technology and engineering. All the product processes developed in this facility are transferred to different api manufacturing plants of the Teva Group in India, Israel, Hungary, Croatia, Mexico, Czech Republic and Italy.
The main objectives of the R&D centre are:
- To develop innovative, cost-effective and scalable processes for Active Pharmaceutical Ingredients (api)/bulk drugs and to support the RA in filing the Drug Master file for api in regulated markets such as US, Europe, Korea, Japan, Brazil etc.
- To develop processes which are safe, environmentally friendly and use green chemistry.
- To develop effective processes for solvent resources and increase eco-efficiency of the products and reduce load on efficient treatment.
- To replace hazardous chemicals and reagents with non-hazardous chemicals with a view to making processes safe for human beings and property.
- To develop methods by HPLC for reaction monitoring, intermediates and final api's and provide routine support by testing R&D samples.
- To identify and characterise the impurities, intermediates and api's through various characterisation techniques and using instruments like LCMS, NMR, FT-IR etc.
- To perform the method validations as per various regulatory guidelines as a part of the DMF package.
- To troubleshoot method-related challenges observed in QC by providing technical support to resolve the queries.
- To respond to the Deficiency letter received from FDA or other Regulatory authorities for api Drug Master File.
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