Arevipharma - Pharmaceutical Agents and Intermediate Products for Pharmaceutical Generic and Research Companies

Arevipharma develops, optimizes and produces pharmaceutical agents and intermediate products for pharmaceutical generic and research companies, and performs synthesis services.

Chemical and process research for effective development and scale-up

A newly renovated laboratory and a pilot plant are available for chemical and process research towards effective process development and scale-up. Process development is supported by a modern analytic development department and quality control.

Production systems for pharmaceutical agents and highly active substances

Using modern and flexible production systems that meet the cGMP standard, Arevipharma produces pharmaceutical agents and highly active substances.

Our pilot plant includes:

• Reactor volume: 3.3m³
• 250l and 630l reactors, made of stainless steel and enamelled
• Temperature range: -20°C to +160°C
• Pressure: 1mbar to 25bar
• Thin-layer distillation
• Centrifuges and filters
• Dryers, screening machines and mills

Our multiple production system includes:

• Reactor volume: 140m³
• Reactors from 1.6m³ to 6.3m³
• Stainless steel and enamelled
• Temperature range: -20°C to +160°C
• Pressure: 1bar to 25bar
• 12 centrifuges, stainless steel and hastelloy
• Two filter dryers and seven vacuum dryers
• Short path distillation
• Screening machines, mills and container mixers
• Tank farm for approximately 20 solvents with a capacity of 1,200m³

Multiple production system for highly-active compounds

• Reactor volume: 7.5m³
• Reactors with 2.5m³ of volume, enamelled
• Temperature range: -15°C to +160°C
• Temperature-controlled centrifuge with on-site purification
• Vacuum dryer with separate filling system, isolator box
• Lab capacities for process development and scale-up
• Separate IPC and QC lab

Quality management, control and assurance for pharmaceutical production

Based on national law and international cGMP regulations - including the code of federal regulations (21 CFR 210-211) of the US FDA and the EC Guide Part II (ICH Q7A) - a quality assurance system has been established to regulate all quality-sensitive methods and procedures and ensure cooperation and support from employees at all levels.

The quality operations department ensures quality control, quality assurance and registration / approval for our units. The responsibilities and primary activities of the quality control department, quality assurance department and responsibilities for production units are separated from one another.

Quality management requires a system for continuous quality improvement, preventive quality assurance and integration of cost-savings potential to ensure the continued high quality of our pharmaceutical agents. Deviations from prescribed goals are investigated and evaluated. The management distinguishes here between preventive actions and corrective actions, both of which are used in the quality system in a transparent and open manner by all involved parties.

Regular audits and inspections also check and confirm compliance with all applicable customer and regulatory guidelines.

Packaging and logistic capabilities

Our packaging and logistics capabilities include:

• Pharmaceutical agents
• Intermediate products - 800 pallets
• Cold storage - 250 pallets
• Narcotics - 80 pallets
• Raw materials - 45 pallets
• Flammable liquids - 510 pallets
• Tank farm - 270 pallets