Our company offers a very wide list of active ingredients for pharmaceutical development: antihypertensives, antifungals, antidiabetics. We offer ingredients for both straight generic formulas, generic plus, and even some new to market ingredients. Our task has been to study different synthesis routes and to implement them with our selected network of fine chemical manufacturers, either in Europe or Asia, depending on the product characteristics. Given our basic chemistry knowhow and involvement, we have implemented several proprietary development routes, which significant reduced manufacturing cost.
We pride ourselves on the continuous help we provide to meet the requirements of the different bodies of government with proper DMFs, product files and guidance for success FDA inspections. This work has resulted in numerous API ready to support your NDA or ANDA in the USA or product files for Canada.
In addition to the ingredients, we have partner with some contract manufacturing organizations in Europe and USA. These partnerships allows us to offer some formulated ingredients and can consider your outsource. We have a dynamic and flexible approach to product registration and can work with you to make a success from the sourcing side.
Some of the products listed are currently under development and therefore pertinent information may not be available at this time. Any product listed which is covered under current patents is available only for use reasonably related to the development and submission of information to the relevant Health Authorities (including the US FDA) to the extent permitted under applicable laws regulating the manufacture, use and sale of Active Pharmaceutical Ingredients and/or their intermediates.