FDF / DRUG PRODUCTS SERVICES in North America
CDMO specializing in sterile unit-dose liquid drug products using Blow-Fill-Seal (BFS) technology for ophthalmic, nasal and inhalation therapies.
About the plant
Unither Manufacturing LLC, located in Rochester, New York, is part of the global pharmaceutical group Unither Pharmaceuticals and operates as a contract development and manufacturing organization (CDMO) specializing in sterile liquid drug products. The facility focuses on the development and commercial manufacturing of unit-dose pharmaceutical formulations for ophthalmic, nasal, and inhalation applications.
The site uses advanced Blow-Fill-Seal (BFS) technology, an aseptic manufacturing process that forms, fills, and seals plastic containers in a single continuous operation. This technology enables the safe and efficient production of preservative-free sterile solutions and ensures a high level of product quality and sterility assurance. The Rochester facility produces sterile solutions primarily for respiratory and ophthalmic therapeutic areas and supports both development and large-scale commercial supply.
The plant provides a wide range of services including formulation development, process development, scale-up, technology transfer, analytical and quality control testing, stability studies, and commercial manufacturing of finished drug products. Its operations comply with international pharmaceutical regulatory standards, including FDA current Good Manufacturing Practices (cGMP), and the site supplies pharmaceutical products to multiple global markets.
With expertise in sterile manufacturing and unit-dose packaging, the Rochester facility plays an important role within the Unither network by supporting pharmaceutical companies in the development, production, and supply of safe and effective liquid drug products.
Compliance
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- ANVISA (Brazil B-GMP)
Activity
- Inhalation products, Sterile forms (ophtalmic, nasal, otic), Nebulization, Fill&Finish, BFS (Blow Fill Seal) ampoules, Bottles, FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Commercial (Phase IV), Human
- Toxicity (OEB classification): N/A
- Controlled substance: N/A
- BSL: 1, 2
- Therapeutic areas: (R) Respiratory system, (S) Sensory organs
- Markets: FDA (USA), EMA (EU), Health Canada (Canada), MHRA (UK), ANVISA (Brazil), Turkish Health Authorities
Batch Size / Reactor
- Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Packaging, Formulation / Galenic design, Process development, Stability studies design, Tech transfer, Scale-up, Pilot batches, Registration batches, Analytical methods validation, Release testing of product, Primary packaging, Secondary packaging, Labeling, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, Stability tests, Identity, Content, Purity / Potency, Impurities, Drug Product – Liquid, API / Excipient – Liquid
