Aenova Group - Location Kirchberg, Switzerland

Aenova Group - Location Kirchberg, Switzerland

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

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Certifications

• 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)

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Activity

• Oral solids / OSD, SoftGel capsules, FDF / DRUG PRODUCTS, COSMETICS, NUTRACEUTICALS, SoftGel capsules, Blister packs manufacturing

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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)
• DEA: N/A
• BSL:
• 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

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Batch Size / Reactor

• Small, Medium, Large

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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

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