The Oral Preparation Research and Development (R&D) Department is comprised of an international team of senior scientists, as well as Ph.D., Master’s, and Bachelor’s degree holders from top pharmacy majors both domestically and internationally. This team boasts extensive hands-on experience in formulation R&D. We have successfully developed dozens of ANDA preparations.
Owing to our profound understanding of the regulatory requirements of the FDA (the USA), EMA (Europe), and CDE (China), we have achieved one-location R&D and multi-location applications for multiple projects. This demonstrates that the R&D capabilities and efficiency of our Pharmaceutical R&D Team are on par with top-tier international pharmaceutical companies.
The pharmaceutical drug products we develop encompass high-barrier generic drugs, first-to-file generic drugs that require patent challenges, new preparations covered by Section 505(b)(2), and innovative drug preparations. We have established the following mature technology platforms for industrialized preparations:
1)An international high-end generic oral drug preparation platform:
We parallelly develop high-end oral dosage forms for the multiple markets US, Chinese, and Europe.
2)High-value-added oral preparation platform:
We focus on high-value-added oral preparations such as first-to-file generic drugs, patent-challenging preparations, improved new drugs, nano-preparations, soft capsules, and preparations for children and the elderly.
3)Sustained and controlled release oral preparation platform:
We have developed technologies such as matrix-controlled release and membrane-controlled release. This includes release technologies with high technical barriers, such as sustained-release pellets, controlled-release micro-pills, micro-tablets, gastro-floating tablets, and osmotic pump tablets.
4)Innovative oral drug preparation platform:
We precisely develop innovative oral drug delivery systems intended for clinical use.