CARBOGEN AMCIS | Vionnaz

CARBOGEN AMCIS | Vionnaz

Highly Potent APIs development and small-scale cGMP production including chromatography and lyophilization

About the plant

Highly Potent APIs development and small-scale cGMP production including chromatography and lyophilization

Opened in 2014, our facility in Vionnaz, located 70 km east of Geneva is fully cGMP compliant and specializes in Highly Potent API (up to category 5) development and small-scale production. Equipped with 3 process development laboratories, a dedicated QC laboratory and 3 production units equipped with reactors up to 30 L, preparative chromatography systems and freeze dryers up to pilot scale.

Activities

• Development and manufacture of highly potent APIs & Intermediates
• cGMP Manufacturing
• Support Activities
• Scale-Up Services

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• World Health Organization (GMP / HACCP)
• ANVISA (Brazil B-GMP)
• PMDA/MHLW (Japan GMP)

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Activity

• CHEMICAL-SYNTHETIC, RSM (Raw Starting Materials), Intermediates, API (Active Pharmaceutical Ingredients) manufacturing

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Features

• Uses: Investigational, 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)
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), MFDS (South Korea)

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Batch Size / Reactor

• Small, 1 - 10 L, 10-100 L

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Services

• Development services, Analytical / QC services, Quality Assurance services, Preformulation studies, R&D, Process development, Process optimization, Process validation, Analytical methods development, Analytical methods validation, Release testing of raw materials, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Co-crystal screening, Polymorph screening, Crystallization screening, Milling, Crystal engineering, PGI assessment (Genotoxic Impurities)

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