FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC BIOLOGICS COSMETICS NUTRACEUTICALS SERVICES OLIGONUCLEOTIDES in Europe
A high-performance production facility that complies with the latest GMP standards for sterile and aseptic liquids, particularly glass ampoules.
About the plant
A company specialize in contract manufacturing, contract filling, and packaging of aseptic and sterile pharmaceuticals, dietary supplements, and cosmetic active ingredients. Filling is carried out in ampoules and, upon request, in other containers.
The production facilities, are equipped according to the latest pharmaceutical standards, including Class A/B cleanroom areas with all necessary facilities in accordance with the latest GMP (Good Manufacturing Practice) standards.
A visitor´s walkway surrounding the cleanroom, accessible at all times, allows potential contract customers to easily experience the high quality of the production facility and processes and conduct necessary audits.
As an independent Austrian company, we can respond competently, reliably, and flexibly to the demands and developments of our time, thus offering our customers a genuine alternative to globalized production.
Certifications
- EMA (EU GMP)
- MFDS/KFDA (Republic of Korea GMP)
Activity
- FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, COSMETICS, NUTRACEUTICALS, SERVICES, OLIGONUCLEOTIDES, Skin products, Hair and scalp care products, Products for nails and cuticles, Oral hygiene products, Skin care, Other skin care products, Cream / paste, Liquid manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 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: 1
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens
- Markets: EMA (EU), PMDA (Japan), MHRA (UK), MFDS (South Korea)
Batch Size / Reactor
- Small, Medium
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics
