Company News

June 2020 – Gateway Pharma applied for 2020 Arch Grant.

 

May 2020 – Co-developed a new immunity boosting dietary supplement for Better Tomorrow and initiated the accelerated stability program. 

 

April 2020 – Applied NIH SBIR phase II grant on Metronidazole Colon-Targeting product for Clostridium difficile infection to progress this project to the completion of Phase 1 human clinical study. 

March 2020 – 1st office response on China patent application CN107174572A entitled “Pharmaceutical Compositions for Colon-Specific Delivery”. 

 

March 2020 – Granted US patent 10,588,864 entitled “Pharmaceutical Compositions for Colon-Specific Delivery”. 

 

January 2020 – Completed Type C meeting with the FDA on clinical study design of Metronidazole Delayed-Release Capsules.

October 2019 – Successfully completed NIH SBIR phase I project on Metronidazole Colon-Targeting product for Clostridium difficile infection in canine model.  

 

November 2018 – Gateway Pharma presented and won the BioSTL Award on the 10th Startup Connection Venture Showcase in St. Louis. 

August 2018 – Received NIH SBIR phase I grant award on the development of a new colon-targeting metronidazole treatment for Clostridium difficile infection. 

July 2018 – Solved stability problem of a product by contract research service and successfully transferred and scaled-up at the client’s GMP facility.

 

June 2018 – Developed Buoy re-hydration dietary supplement for Better Tomorrow, and launched on the US market.

February 2018 – Received Qualified Infectious Disease Product (QIDP) designation for Metronidazole 505(b)(2) product, qualifying additional 5-year exclusivity.

 

March 2017 – Submitted the Pre-IND of a 505(b)(2) product for Clostridium difficile Infection and completed the discussion with the FDA.

 

October 2016 – Invited Speaker at "6th Annual Drug Delivery and Formulation Asia Summit" at Shanghai, China.

 

2015-2017 – Consulting services to Long Pharmaceuticals (currently Alkem Labs) and guided the company submitted five ANDA products including ointment, creams, and nasal sprays. 

 

2012-2015 – Contract research services to DanSol Pharma and developed five ANDA solid products for FDA submission including nanoparticle tablet, extended releases-tablets, and stability challenging delayed-release capsules.

©2020 by Gateway Pharmaceutical

All Rights Reserved.