CARBOGEN AMCIS | Neuland

CARBOGEN AMCIS | Neuland

Development and medium scale manufacturing

About the plant

Development and medium scale manufacturing

Our facility in Hunzenschwil (Neuland) – in the district of Lenzburg in the canton of Aargau in Switzerland – is located 25 km West of Zurich. The facility was opened in 2000 and is our second site to house laboratories for development activities with highly potent compounds.

Activities

• Analytical services
• API and intermediate stability studies
• API process research and development
• Small scale commercial API supply

---

Certifications

• FDA (cGMP)
• World Health Organization (GMP / HACCP)
• PMDA/MHLW (Japan GMP)

---

Activity

• CHEMICAL-SYNTHETIC, SERVICES, Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients) 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)
• 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), Turkish Health Authorities

---

Batch Size / Reactor

• Small, Medium, 1 - 10 L, 10-100 L, 100 - 1,000 L

---

Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, DMF (Drug Master File) preparation and submission, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Crystal engineering, PGI assessment (Genotoxic Impurities), Customized block synthesis, Impurity synthesis

---