About Summit Biosciences

A Fast-Growing Leader in the Field of Intranasal Pharmaceuticals

Summit Biosciences is a specialized pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray medicines. We collaborate on the development of products with our clients and manufacture at commercial scale for the US and European markets.

We Have Optimized Our Integrated Operations for Development through Commercial Production

Manage small volumes at high speeds

Handle extremely small volumes at high-speeds using custom processes and equipment

Critical process parameters

Tight control of critical process parameters which may impact product quality

Method development and validation expertise

Unmatched analytical and microbiological method development and validation expertise

Present

September 14, 2017

Following a pre-approval inspection by the MHRA, we received EMA approval to commercially manufacture prescription nasal spray drug products for the European market.

2017

August 15, 2016

We shipped the first two batches of Sumatriptan Nasal Spray for commercial sale.

February 19, 2016

The FDA approved our Sumatriptan Nasal Spray for commercial manufacture.

2016

2015

March 28, 2014

Following a pre-approval inspection by the FDA, we received approval to manufacture a controlled substance nasal spray drug product for commercial distribution. No 483s were issued.

2014

October 20, 2009

Summit Inception

2009

What Makes Us Stand Out

  • We have a proven track record in commercial production of unit-dose, nasal spray products
  • We have a proven capability to develop bi-dose and multi-dose nasal spray products
  • We are the only company in the United States focused on nasal spray development and manufacturing as its core competency
  • Our manufacturing facility is designed and equipped specifically for nasal spray products
  • Our scientists, engineers and technicians are experts in their field, and focused on operational excellence

A State-of-the-Art cGMP Manufacturing Facility

Our customers trust the production of their intranasal products in our FDA and EMA approved and DEA registered cGMP manufacturing facility.

Our Specialty Revolves Around Nasal Spray Technologies

We are proficient in the development and production of pre-filled, disposable, intranasal (and sublingual) spray products:

  • unit-dose
  • bi-dose
  • multidose
View Our Manufacturing Facility

Market Needs

We help our clients address important needs for the management of chronic and acute care conditions by improving upon the following:

  • Safety
  • Efficacy
  • Convenience
  • Compliance
  • Access / Affordability
Our Capabilities

Areas of Interest for Future Development

Summit's nasal spray technology can be developed to solve unmet medical needs. Examples of areas of interest to explore with potential clients include:

  • Pain
  • Sedation
  • Addiction
  • Opiate overdose
  • PONV/CINV
  • ADHD
  • Seizures
  • Hypoglycemia
  • Women's health
  • Sexual dysfunction
  • Obesity
  • Diabetes
  • Allergy

A Leadership Team Backed by Experience and Integrity

We aspire to lead our industry in the quality of work that we perform and in our compliance with regulations while at the same time finding and applying innovative ways to improve outcomes.