Company News

September, 2020 – Gateway is working with the NIH NIAID on GMP manufacturing of Metronidazole 505(b)(2) product for treating Clostridium difficile Infection. 

 

May, 2020 – Applied NIH NIAID grant on Metronidazole 505(b)(2) product Phase 1 human clinical study. 

March, 2020 – Our key colon-delivery patent  10,588,864 received approval from the US PTO. 

March, 2020 – Office response on China patent application CN107174572A 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.

November, 2018 – Gateway won the BioSTL Award 

on the 10th Startup Connection Venture Showcase

in St. Louis. 

August, 2018 – Received the NIH SBIR Phase I grant on Metronidazole Colon-Delivery for treating Clostridium difficile Infection. 

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

February, 2018 – Received QIDP designation for Metronidazole 505(b)(2) product and additional 

5-years of market exclusivity.

 

March, 2017 – Submitted Pre-IND package of Metronidzole 505(b)(2) product for treating   Clostridium difficile Infection.

 

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

 

2015-2017 – Consulting services to Long Pharma

(Alkem Labs) on semi-solid product development including ointment, creams, and nasal sprays, and guided the company on five FDA submissions. 

 

2012-2015 – Contract research services to DanSol Pharma, Princeton Pharma and  PharmaMax on ANDA solid products including nanoparticle tablet, extended releases-tablets, bi-layer tablets and stability challenging delayed-release capsules.

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