TWi- insights into complex technologies and difficult-to-manufacture generics

TWi is focused on the development of Niche Generics with higher technical barrier, such as applications via Paragraph IV pathway with first-to-file (FTF) status and 180-day exclusivity, first-to-market (FTM), or generic drugs with limited number of competitors for the US market.

TWi has already filed several Abbreviated New Drug Applications (ANDAs) for its niche generic products with US FDA with additional 15~20 projects in R&D pipeline. Unlike the general generic pharmaceutical products, there is only a handful of pharmaceutical companies worldwide focusing on Niche Generics, thus the competition landscape is different from the general generics. To excel in this market and to stay ahead of the competition, TWi engages superior integration of the following competitive advantages:

  • Innovative Formulation Design and Development
    Unlike the traditional generics pharmaceutical companies, TWi possesses the formulation and R&D capacity and know-how required to challenge the patents of branded drugs. In addition, TWi has the expertise in the development of analytical and validation methods.
  • Patent Analysis and Legal Strategy
    TWi is well experienced in fully analyzing the patent claims for each compound and in designing subsequent legal strategy to bypass or invalidate the brand manufacturers' patent claims.
  • Design of Bioequivalent (BE) and Pharmacokinetic (PK) Clinical Studies
    TWi is experienced in designing and executing cost-effective BE clinical studies under US FDA guidelines to demonstrate TWi's generic products are bioequivalent to branded products.
  • State-of-the-Art and Approved Production Facility
    TWi's Chungli Plant has passed the audit by US FDA and TFDA, and, since 2009, TWi's Chungli Plant has consistently supplied and exported good quality pharmaceutical products to US.
  • Regulatory Affairs
    Since TWi has filed several ANDAs with US FDA, TWi is well experienced in preparing and drafting ANDA application documents. Therefore, TWi is able to submit the most complete ANDA application package shortly after the completion of BE studies in order to ensure that US FDA will accept TWi's ANDA application in the shortest possible timeframe.