About usNorth America2

Our location

Unither LLC USA

Rochester, NY

2013: This facility was acquired from UCB Pharma to establish a US manufacturing footprint. With our existing expertise in the development and manufacture of oral solids and liquids our capabilities have been enhanced by adding single unit dose capacity in Rochester New York,  introducing the North American marketplace to the significant benefits offered by new unit dose forms (BFS and stick-pack).

234: number of current staff


Delivering 50 million bottles per year
Bottle contents from 15 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 scientists and the expertise to develop new products for the US market.

Site Specialty

  • Dry (tablets and hard-shell capsule) and liquid (bottle) forms implementation of BFS and liquid stick-pack technologies in Rochester
  • Solid orals, (capsules, tablets), liquids and control release suspensions employing resin complexation expertise.
  • Unistick® and Blow-Fill-Seal technologies to capture CDMO (Contract Development and 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)

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.

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

Contact Rochester - How to get there

Unither Manufacturing LLC

755 Jefferson Road
Rochester, NY 14623
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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