Switzerland Europe
FDF / DRUG PRODUCTS COSMETICS NUTRACEUTICALS in Europe
Competence Center Soft gelatin capsules.
About the plant
The Aenova site in Kirchberg has special expertise in the development, production and analytical testing of pharmaceutical soft gelatin capsules, including high potent APIs.
In our competence center for pharmaceutical soft capsules, we apply decades of know-how and state-of-the-art infrastructure to deliver flawless quality to our customers worldwide.
With our innate Swiss reliability, we always deliver our products on time. Hand in hand, our experienced team works with passion to find innovative solutions for demanding customer needs. Our high service standards are the driving force for long-term, successful partnerships with our customers.
More information here: Aenova Group
Compliance
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- TGA (Australia GMP)
- Roszdravnadzor (Russia GMP)
- MFDS/KFDA (Republic of Korea GMP)
- SFDA (Saudi Food & Drug Authority)
- TITCK (Turkish Health Authorities)
- 14001
Activity
- Oral solids / OSD, SoftGel capsules, FDF / DRUG PRODUCTS, COSMETICS, NUTRACEUTICALS, Blister packs manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, 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), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V06) Nutrients
- Markets: FDA (USA), EMA (EU), TGA (Australia), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Tech transfer, Primary packaging, Secondary packaging, Labeling, Serialization
Other plants of this company
FDF / DRUG PRODUCTS BIOLOGICS in Europe Competence Center animal health products and sterile technologies.
FDF / DRUG PRODUCTS in Europe Competence center for conventional solids and clinical services.
FDF / DRUG PRODUCTS NUTRACEUTICALS in Europe Competence Center and one-stop shop for Soft gelatin capsules and VegaGels®.
