FDF / DRUG PRODUCTS in Europe
Oral forms (liquid & solid)
About the plant
The CDMO plant is located in Northern Italy, between Turin and Milan. It was originally built in 1990 and acquired in the 2000s. The company specializes in the development and manufacturing of pharmaceutical products in solid and liquid oral forms. The company is authorized to handle controlled substances. Listed below are the finished dosage forms we manage:
Granules
Capsules (immediate release, sustained release, filled with mini-tabs/pellets)
Tablets (coated, uncoated)
Syrups and suspensions
Mono-dose vials with caps
Oral drops
The plants occupies a total area of 76,000 square meters, with 30,000 square meters currently covered.
The company is expanding the covered area with a new warehouse and an additional 1,000 square meters of pharmaceutical-grade space to accommodate new equipment (fluid bed granulator) dedicated to the production of solid oral forms.
The company continues to invest in maintaining its production site at the forefront and supporting the growth of its customers and business.
The company is also available to evaluate dedicating new areas to specific production requests from its clients.
We are the right partner to rely on to secure your business!
Certifications
- ISO
- EMA (EU GMP)
- World Health Organization (GMP / HACCP)
Activity
- Oral liquids and semisolids, Oral solids / OSD, Bottles, Ampoules, Oral solutions, Oral suspensions, Syrups, Tablets, Hard capsules, Granules / Pellets, Powders, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
- Controlled substance: High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: N/A
- Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system
- Markets: EMA (EU), MHRA (UK), MFDS (South Korea), Russian Health Authorities
Batch Size / Reactor
- Small, Medium, Large
Services
- Development services, Manufacturing services, Preformulation studies, R&D, Process development, Process optimization, Process validation, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records
