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72% and 7.99% of the total sales from Europe during the respective periods. The above-mentioned expenses for Fiscal 2012 and for the nine-month period ended December 31, 2012 were fully capitalised. We categorise the process of registration of a product and receiving marketing authorization in the European markets in the following stages: Simultaneously, we validate the method in various parameters such as precision, specificity and robustness.
On an average, this process takes about six to 24 buy xanax online prescription months. •Stage III: Validation batch manufacturing- In this stage, we manufacture validation batches of coimnercial scale in a GMP approved manufacturing facility and subject the same to short term and long term stability to derive shelf life. On an average, this process takes about two to four months.
•Stage IV: Bio-equivalence and stability studies- Subsequently, we conduct bioequivalence studies on healthy volunteers to prove the effectiveness of developed formulations versus reference product hydrocodone overnight vicodin as per regulatory guidelines of various regulatory agencies. We also generate accelerated (short term) and room temperature (long term) stability data to derive the shelf life / expiry dates of products. Bioequivalence studies generally take about three to twelve months and stability studies for dossier filings typically take between six to seven months, depending on the stability of molecules and formulations.
The period for stability study may be longer for certain products buy xanax online prescription depending on complexity of the molecule as well as specific regulatory requirements. We intend to buy codeine hydrocodone online pill utilize up to ' 1,219.25 million from the Net hydrocodone bitartrate pseudoephedrine hydrochloride Proceeds towards payment of marketing authorization fees for the products being currently developed by us for the European market. As regards payment for the marketing authorization fee for such products, we have entered into an agreement dated February 7, 2013 with Accord Healthcare (UK) Limited ("Accord") whereby Accord will procure buy xanax online prescription dossiers from us in relation Buy Viagra or Cialis Now From & Get 10 bonus pills FREE! to filing for receiving marketing authorization in Europe and, on a regular basis, we will compensate Accord for the actual expense incurred by it towards the filing for marketing authorization during such period. As per of the agreement, Accord will be entitled to compensation only of the fee incurred in receiving marketing authorizations of the products, on actuals.
The estimated fee for marketing authorization in Europe is dependent on the applicable regulatory fee based on the procedure under which the application has been made as well as the strengths of the product. The number of strengths of a product refers to the number of different buy xanax online prescription dosages manufactured for one product.
The stage and strength-wise description of these 40 products which are under development for European markets is set forth below: Stage Number of Number of products strength- wise products One Two Three Four or more API sourcing/ material availability 23 12 7 2 2# Prototype formulation development/analytical method development and validation 14 4 4 4 2390 Validation batch manufacturing 1 - - - 1 Bio-equivalence and stability studies 2 2 - - - Total 40 18 11 6 5 One of the products is proposed to be developed in eight strengths. One of the products is proposed to be developed in seven strengths. These products may be granted marketing authorizations in Europe based on one of the four main regulatory processes, which entail different timelines as well as filing fees. Historically, we have received marketing authorizations mainly under the 'mutual recognition procedure' or 'decentralized procedure'.
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