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Plant investigation by FDA is a key milestone of Orient Pharma. Therefore, strategically we focus on developing products which can be submitted to FDA immediately, in order to drive the plant investigation by FDA. | |
In short term, we focus on developing generics with higher market potential and technology barrier, to enhance the plant capacity utilization rate. | |
In long term, due to the high R&D costs and risks, we focus on FDA 505(b)(2) drugs, including new dosage form, new formulation, new indication, and new drug combination, to lower the development risks and to raise the successful rate. Compared to developing generics, although the R&D costs are higher and the timeline is longer, if the development is successful, price competition can be avoided, and we can gain higher profit to enhance the long term stable growth of the company. | |
Collaborate with European and US companies to develop FDA 505(b)(2) drugs by combining each other’s profession, to shorten the development timeline and the time for new product launching. | |
During the new drug development period, we also focus on the patent application to protect our intelligent property, and to raise extra value of the products. | |
Apply for the subsidy for science from Ministry of Economic Affairs, to share R&D costs and to lower risks. | |
Target products for development: a. Old drugs with new indications:e.g. OC Oral Solution b. Improvement of dosage form to raise the clinical effects:e.g. ORADUR® c. Lower drug side effects:e.g. new formulation for treating tuberculosis |