Unither Manufacturing LLC, part of Unither Pharmaceuticals, was established to expand our international presence following the acquisition of a facility from UCB Pharma in October 2013. Proudly based in Rochester, NY, a vibrant and dynamic region known for its rich history and innovation, our facility enhances our American footprint, giving us strategic access to the entire American continent.
Employing over 320 dedicated professionals, our site leverages state-of-the-art technology to ensure efficiency and quality at every stage of drug development and manufacturing. As an American CDMO, we specialize in developing a wide range of pharmaceutical products, including Phase I-III products, generics, over-the-counter medicines, branded products, Class 2, 3, and 5 controlled substances, and medical devices. Our flexible collaboration models are tailored to meet your specific needs, whether you are introducing a new product or revitalizing an existing one.
In addition to our Rochester facility, Unither Pharmaceuticals operates other strategically located sites in Brazil, France, and China. These locations serve as backup sites, ensuring robust global support and continuity for our clients.
Our U.S. pharmaceutical plant based in Rochester is designed to handle various dosage forms, ensuring comprehensive solutions for our customers:
Sterile Blow-Fill-Seal (BFS) Solution, suspension, gel, emulsion for preservative free eye drop and inhaled medication
Filling: 0.25 to 3.0 mL
Therapeutic areas: Ophthalmology, Inhalation Therapy, Rhinology, Otic Care, Antisepsis, Wound Care
Unistick® Liquid Stick-PackSolution, suspension, gel for oral and topical application
Filling: 2.5 to 10 mL
Therapeutic areas: Ideal for pediatric, geriatric, rare disease and on-the-go lifestyles
Oral Liquid Bottles
Solutions and suspensions for oral use (immediate or sustained release oral products including controlled substances)
Filling: 15 to 473 mL
Therapeutic areas: Various, including treatments for respiratory conditions, gastrointestinal issues, pain relief, and more. These bottles are ideal for delivering liquid formulations that require precise dosing and are often used in pediatric and geriatric care, where swallowing tablets may be challenging.
Unither Manufacturing LLC has a 6,000 sq. ft. cGMP pilot workshop for developing, scaling up, and conducting clinical trials of non-sterile and sterile liquids. Our lab capabilities include physicochemical methods to analyze appearance, viscosity, particle size, and melting point, alongside identification techniques like TLC, HPLC, SDS PAGE, and FTIR.
We provide biological testing for sterility, bacterial endotoxins, and specific microorganisms to ensure product safety. Our pharmaceutical technical procedures include HPLC characterization (UV, DAD, RI, MS-MS), GC, ICP-MS elemental analysis, and ion chromatography. Performance testing covers dissolution, release rate, uniformity, and friability, while cleaning verification ensures equipment cleanliness through analytical and microbiological methods.
Our expertise includes blow-fill-seal (BFS) technology for preservative-free eye drops and inhaled medications, liquid stick-packs for oral and topical applications, and pharmaceutical bottles for various therapeutic areas, offering both immediate and sustained release formulations.
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 Manufacturing LLC 755 Jefferson Road Rochester, NY 14623 Phone: +1 585-475-9000 Fax: +1 585-272-3905 Email: contact@unither-pharma.com
