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North America


Unither LLC USA

Rochester, NY
This facility was acquired from UCB Pharma in October 2013 to establish a US manufacturing footprint. Deep expertise in the development and manufacture of oral solids, liquids, sustained release, and controlled substances has been enhanced by adding single unit dose capabilities in order to introduce the North American marketplace to the significant benefits offered by such forms.

Bottles 

Bottles
Delivering 50 million bottles per year
Bottle contents from 10 mL to 148 mL

 Liquidstick Liquid Stick-Pack
Delivering 250 million sticks per year
Unit-doses contents from 2.5 mL to 10 mL
 BFS Sterile Blow-Fill-Seal (BFS)
Delivering 1 billion unit-does per year
Unit-dose contents from 0.25 mL to 3.0 mL

Dedicated Team

A team of formulation and analysts experts develop new products for the US market.

Site Specialty

  • Unistick® and Blow-Fill-Seal technologies to capture CMO (Contract Manufacturing Organization) opportunities in the North American Region.

Standards & Regulations

  • FDA cGMP and European GMP
  • DEA approved for schedule 2,3, 4 and 5 controlled substances (US standards)

Technologies & Products

  • Formulation and Process Development for Drug Products
  • Analytical Services (Development and/or Validation)
  • cGMP Clinical Batches Phase II and III (Medium and Large Scale)
  • Primary Packaging of Clinical Batches
  • ICH Stability (Pre-stability, Development, Clinical Batches)
  • Scale-up and Manufacturing Process Validation
  • Analytical Services (Quality Control)
  • cGMP Clinical Batches (Pilot and Industrial Scale)
  • ICH Stability (Clinical Batches Registration and On-going)
  • Liquid Stick-Packs: Unisticks®
  • Blow-Fill-Seal Technology 
  • Tablets in Blisters
  • Hard-shell Capsules Filled in Immediate Release and Extended Release Blends
  • Liquid Bottles: Solutions and Suspensions for Oral Use in Extended and Controlled Release Formulations

Authorizations & Certifications

The site is FDA inspected and DEA approved. The site has been inspected by Turkish Ministry of Health, MHA (Mexico), ANVISA (Brazil) EMA (EU), FDA (US), MHRA (UK) and Health Canada.

Contact Rochester - How to get there

Unither LLC
755 Jefferson Road
Rochester, NY 14623
USA
Phone: +1 585-475-9000
Fax: +1 585-272-3905
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

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