Site specialization
Located in Monroe County, New York, the Rochester site develops and manufactures preservative-free sterile liquid forms (BFS), oral and topical stick packs, pharmaceutical bottles, and controlled substances.
Key figures
+300
employees
400 million
BFS single doses/year
250 million
stick packs/year
12 countries
where products manufactured for our clients are distributed
Expertise and know-how
Development
Formulation and analytical development, manufacture of clinical batches, stability studies, and expertise in ophthalmic development.
Analytical Development
The entire development and production cycle: from formulation to manufacturing and regulatory support.
Clinical Batch & Placebo Manufacturing
Agile GMP production to secure your clinical trials.
Technology Transfer & Pharmaceutical Scale-Up
Secure transfer and industrial scale-up of liquid pharmaceutical products from development to commercial manufacturing.
Regulatory Support
Comprehensive regulatory support, from pharmaceutical development to CTD/eCTD document submission.
Commercial batches manufacturing
CDMO specializing in the industrial manufacturing of drugs and medical devices: sterile BFS, liquid stick packs, vials, and sprays.
Locally manufactured products
Sterile single doses (Blow-Fill-Seal): ophthalmology, rhinology, inhalation, antisepsis, ENT
Liquid stick packs: oral and topical routes
Pharmaceutical bottles: syrups, solutions, suspensions (immediate or slow release), controlled substances (C2, C3, C5)
Standards and certifications
Authorisations :
– FDA (United States)
– DEA (United States)
– MHRA (United Kingdom)
– ANVISA (Brazil)
– EMA (Europe)
– Health Canada (Canada)
– UL (United States)
– Ministry of Health (Mexico)
– Ministry of Health (Turkey)
Standards and certifications:
– cGMP FDA (Sep 2024)
– general GMP (May 2019)
– Sterile (2018) and non-sterile (2020) inspections
– International certificates for medical devices
Address
Address:
Unither Manufacturing LLC
755 Jefferson Road
Rochester, NY 14623
United States
Contact:
Phone: +1 585-475-9000
Fax: +1 585-272-3905
Email: contact@unither-pharma.com
How to get here:
By road: via I-390, near Rochester Airport
By plane: Rochester International Airport (ROC), 10 minutes away
By train: Amtrak Rochester station