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
This CDMO located in North America, is part of the global pharmaceutical group 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 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 facility plays an important role within the group 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: Lowest potential for abuse
- BSL: N/A
- Therapeutic areas: (R) Respiratory system, (S) Sensory organs
- Markets: FDA (USA), EMA (EU), Health Canada (Canada), MHRA (UK), ANVISA (Brazil)
Batch Size / Reactor
- Medium, Large
Services
- Development services, Manufacturing services, Formulation / Galenic design, Process development, Stability studies design, Tech transfer, Scale-up, Pilot batches
Other plants of this company
FDF / DRUG PRODUCTS SERVICES in APAC The site specializes in the development and production of solid and liquid pharmaceutical forms, both sterile and non-sterile.
FDF / DRUG PRODUCTS NUTRACEUTICALS SERVICES in LATAM This site specializes in the manufacturing of liquid and solid forms for the pharmaceutical and nutraceutical markets.
FDF / DRUG PRODUCTS SERVICES in Europe Make affordable healthcare solutions that improve and simplify patients lives
