UNITHER MANUFACTURING LLC
This facility was acquired from UCB Pharma in October 2013 to expand our international presence. The site now has more than 320 employees.
Our U.S. pharmaceutical laboratory at the Rochester site is responsible for the development of Phase I-III products, generics, over-the-counter medicines, branded products, Class 2, 3 and 5 controlled substances and medical devices, in the following dosage forms:
|Blow-Fill-Seal (BFS) |
Filling: 0.25 mL to 3.0 mL
Solution, suspension, gel, emulsion for preservative free eye drop and inhaled medication
Filling: 2.5 mL à 10 mL
Solution, suspension, gel for oral and topical application
Solutions and suspensions for oral use (sustained and controlled release formulations)
|Tablets & capsules|
Hard shell capsules filled with immediate release and prolonged release mixtures
A dedicated R&D team
Our pharmaceutical company in the USA boasts a dedicated 6,000 sq. ft. cGMP pilot workshop, enabling various non-sterile oral solid and liquid formulations to be manufactured for development, process scale-up, and clinical trials. For oral liquids, batch sizes range from 0.5 to 560 L.
For controlled release bead processes, GPCG-3 and GPCG-5 processors with Wurster inserts are available. Batch sizes in these units range from approximately 1 to 25 kg. For process scale-up and commercial manufacture, two GPCG-60 units are available with 18 and 32-inch Wurster inserts for batch sizes ranging from approximately 30 to 225 kg.
Our pharmaceutical company in the USA undertakes tableting and liquid stick-pack filling operations under industrial conditions. Tablet batch sizes can range from 1.5 to 75 kg with additional equipment available in commercial manufacturing for scale-up.
- Formulation and Development & transfer (BFS (Eye drops & Inhaled medication) / Liquid stick-Pack / liquid bottles)
- Analytical Services (Development and/or Validation, Quality control)
- 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
- cGMP Clinical Batches (Pilot and Industrial Scale)
- ICH Stability (Clinical Batches Registration and On-going)
Authorizations & Certifications
The Rochester site is inspected by the FDA (Food Drug and Administration), DEA certificate, as well as: Turkish Ministry of Health, MHA (Mexico City), ANVISA (Brazilian agency) EMA (European agency), MHRA (UK) and “Health Canada“, etc.
755 Jefferson Road
Rochester, NY 14623
Phone: +1 585-475-9000
Fax: +1 585-272-3905