Didrex vs. phentermine
For further details of the regulatory process, see the section titled "Our Business" on page 114.
We intend to file the applications for the above products under the decentralized procedure.
The decentralized procedure involves simultaneous applications for marketing authorizations in various countries. Under this procedure, identical dossiers are submitted in all member states where marketing authorization is sought. A Reference Member State ("RMS"), selected by the applicant, prepares a preliminary assessment report and sends it to the Concerned Member States ("CMS"). We intend to file applications for marketing authorizations with the United Kingdom as the RMS and in approximately 28 other jurisdictions in Europe, as CMS, based on the availability of the slot for filing an application and the expected market size of the product. Following didrex vs. phentermine is a table depicting the approximate aggregate amount of fee for marketing authorization per product, on the basis of the didrex vs. phentermine strength, based on fee for marketing authorization in 29 jurisdictions in Europe under the decentralized procedure, as per the applicable fee provided on the websites of the respective regulators: Strength of a product Estimated fees (In ' million)* One strength 20.57 Two strengths 29.38 Three strengths 38.19 Four strengths 47.00 Five strengths 55.81 Six strengths 64.62 Seven strengths 73.43 Eight strengths 82.24 *The Euro amounts have been converted into Rupee amounts based on the RBI reference rate as of May 31, 2013 (One Euro equivalent to ' 73.68).
Based on the above estimate of fee for marketing authorization under the decentralized procedure and the number of strengths of the products, the break-down of the 40 products in 29 jurisdictions in Europe to be registered by us with expected period of filing for receiving marketing authorization and the estimated expense is provided below: Stage Number of Estimated number of Estimated expense fees for products products to be tiled in Fiscal marketing authorization in Fiscal (In ' million) 2015 2016 2015 2016 API sourcing/ material availability Formulation development/analytical method development and validation Validation batch manufacturing Bio-equivalence and stability studies 23 8 15 252.66 405.46 Nil Nil Nil 14 14 Nil 472.99 1 1 Nil 47.00 2 2 Nil 41.14 Total 40 25 15 813.79 405.46 The process of developing products for marketing authorizations is dynamic and the list of products so identified from the products under development or the timeline of their development may need to be reviewed by the Company subsequently. Accordingly, we may be required to review the didrex vs. phentermine requirement of funds for procuring marketing authorizations depending on any change in regulatory hydrocodone bit homatropine fee in one or more jurisdiction, increase (or decrease) in the number of strengths didrex vs. phentermine in which the product is proposed to be manufactured and any change in potential demand of products in the European markets. Setting up research and is tramadol narcotic development facility As part of our long term strategy to continuously improve our R&D capabilities, with a focus on capturing more high-value first-to-market opportunities in key markets, our Company proposes to expand our R&D infrastructure by setting up a new research and development facility within the premises of our Matoda facility. We intend to utilise diet medication online phentermine an aggregate of ' 687.20 million from the all tramadol hcl Net Proceeds towards setting up the new facility and acquiring the required plant and machinery for the same.
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