We capitalize on our technical advantage through our state-of-art facilities and the development of drug formulations and special generic drugs to create the characteristic of difficult-to-make pharmaceuticals. Through our global commercial network supported by strategic partners, we are able to launch into the global pharmaceutical market.
The Development Process
Material sourcing is an important factor during the development. Materials which are hard to obtain are prone to become our development targets.
Our skilled regulatory affairs specialists are fluent in the eCTD preparation and submission processes, and have completed several cases of ANDA applications.
Lotus has PIC/S certification by FDA, DOH, Executive Yuan and is USFDA inspected and qualified, it became one of few pharmaceutical companies in Taiwan to meet the requirements of USFDA.
We choose difficult-to-develop formulations, such as orally administered special formulations, sublingual and slow release formulations, and we usually avoid development of mass market products to avoid price lowering due to stiff competition.
We have more than 10 years of experience in the design and execution of Bio-equivalence (BE) studies, efficacy tests, and clinical trials. Our experienced specialists execute and control the progress of clinical trials, so that registration and permit applications are processed expeditiously.
Lotus was the first accredited pharmaceutical company to obtain approval of nearly 20 new drugs under the safety guidelines of the “July 7 Announcement” by completing clinical trials and pharmacokinetics/pharmacodynamics tests in the past decade.
Key Direction for R&D
- Development of modified release pharmaceuticals
Controlled-release formulation, rapid-dissolving formulation, and other specific formulations
- Development of new indication drugs
- Development of difficult-to-make generic drugs
Such as oncology drugs, contraceptive drugs, antipsychotics, etc.
- Development of new complex drugs
Anti-addiction, anti-hypertension, and diabetes drugs