Products and Services
March 2017 - Completed Pre-IND package of a 505 b2 product for Clostridium difficile Infection and received Written Response from FDA.
Feb 2018 - Gateway Pharma's Metronidazole Delayed-Release Capsules received a QIDP (Qualified Infectious Disease Product) designation from the US FDA for the treatment of Clostridium difficile infection, which qualifies this product for a fast review and a 5-year exclusivity extension.
March 2017 - PCT patent filed on Colon Specific delivery product for treatment of Clostridium difficile Infection.
June 2016 - New colon drug delivery system patent is filed in China with China PTO.
March 2016 - A new 505(b) drug delivery system patent has been filed with US PTO. This drug delivery system is one of a kind with targeted delivery in the colon.
October 2016 - Invited Speaker at "6th Annual Drug Delivery and Formulation Asia Summit" at Shanghai, China.
July 2015 - New dosage form development for an NDA drug focusing on improving drug efficacy, result of a strategic partnership with clinical practitioners.
June 2015 - Successfully performed technology transfer of an ANDA formulation and process to a strategic partner.