TWi Pharmaceuticals, Inc. (TWi) is a technology-based special pharmaceutical company focusing on the development and commercialization of "High Barrier Generics" drugs primarily for United States. Unlike the common generic drugs, developing high barrier generic drugs require a full array of expertise, including advanced scientific research, process development, patent analysis, regulatory compliances, and market and competitio...
TWi Pharmaceuticals, Inc. (TWi) is a technology-based special pharmaceutical company focusing on the development and commercialization of "High Barrier Generics" drugs primarily for United States. Unlike the common generic drugs, developing high barrier generic drugs require a full array of expertise, including advanced scientific research, process development, patent analysis, regulatory compliances, and market and competition analysis. TWi focuses on the development of the following two categories of high barrier generic drugs:
Paragraph IV:
For generic drugs, Abbreviated New Drug Applications (ANDAs) are filed with US FDA for approval. These ANDAs are categorized into 4 categories - Paragraph I, II, III and IV. TWi's specialty is in the application of Paragraph IV (PIV) drugs which require strong science and technical know-how . Using our expertise in designing innovative alternative formulation, TWi is able to challenge or bypass the brand manufacturer's patent protection and to provide patients with drugs which have the same efficacy and quality as the branded drugs at a lower cost prior to the brand drugs' patent expiration.
Generics with High Technical Barriers:
For some drugs, although the patent protection for those drugs has already well expired, these drugs are still oligopolized by the original brand company and/or a limited number of generic companies due to high technical or other entry barriers. This type of drugs is also the key development focus for TWi.
TWi Biotechnology, Inc. is a 100% fully-owned subsidiary of TWi Pharmaceuticals, Inc., focusing on the new drug research and development. Using innovation, quality, and efficiency as its core competency, TWi Biotechnology is dedicated on the development of treatment for innate inflammatory related diseases in metabolic, ophthalmology, and dermatology areas. Coupling with TWi's expertise and experience in formulation development, toxicology study, drug delivery system, clinical trial design, regulatory approval, TWi Biotechnology is poised to become the leader in developing treatment for above mentioned therapeutic areas.
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