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:
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.
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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.
Unither LLC 755 Jefferson Road Rochester, NY 14623 Phone: +1 585-475-9000 Fax: +1 585-272-3905 Email: unither@unither-pharma.com
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