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ACTIVE INGREDIENTS FOR LIFE


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in d e x 1. History

4 -5

2. Performance

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3. Custom Manufacturing

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4. Production

10 -15

5. Quality Management

16 -19

6. Packaging and Logistics

20 -21

7. Safety and Environment

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Co m p e te nc e w i t h Act i ve I n g re d i e nt s sin c e 1874 Arevipharma is a company with more than 130 years of expertise in the development and production of active pharmaceutical ingredients and advanced intermediates for the pharmaceutical industry.

1990 // The company was privatized and became an independent public limited company Arzneimittelwerk Dresden. 1991 // Arzneimittelwerk Dresden was acquired by ASTA Medica AG.

1874 // Dr. Friedrich von Heyden worked out the technical utilization of Hermann Kolbe’s invention of the synthesis of salicylic acid and founded the world’s first production facility of an active ingredient. 1979 // Arzneimittelwerk Dresden became part of GERMED and the competence center of research and development for active ingredients and pharmaceuticals. The multi-purpose plant started operating.

1997 // Establishment of new chemical & development laboratories and restructuring of the chemical pilot plant. First FDA inspection, without 483. 1999 // Installation of a dedicated production facility for high potent compounds.


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2000 // Production facilities for active ingredients were integrated into the fine chemical division of Degussa-H端ls AG, later than Degussa AG. 2004 // The manufacturing site was acquired by HEXAL AG. 2005 // HEXAL group was acquired by Novartis group. 2007 // Since August 2007 the company has been operating independently as Arevipharma GmbH, owned by the previous HEXAL owners.

arevipharma - vi are in germany


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Sco p e o f P e r fo r man c e Arevipharma develops, optimizes and produces active ingredients for generic and research based companies and carries out contract syntheses for third-party customers. For an efficient process development and for scale-up, the chemical research and process engineering departments have at their disposal newly equipped laboratories and a pilot plant. Process development is supported by a modern analytic department and quality assurance. A close cooperation of the departments of process development, quality assurance and production ensures a fast and efficient

development of new manufacturing processes – supporting the procedures from the laboratory up to commercial production. The core elements of the production of our substances are a stateof-the-art multi-purpose plants with a vessel capacity of 140 m³ as well as a plant for the synthesis of high potent substances for the therapy of cancer and controlled substances against pains. The highest levels of quality and health, safety and environmental standards are routinously audited by authorities, like FDA and by customers.

arevipharma - vi are close to customers


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Cu s to m Ma n u fact u r i n g „Getting together is the beginning. Working together is success.“ (Henry Ford) Arevipharma is a reliable partner in fast process development, scaleup and cGMP manufacturing of active pharmaceutical ingredients for clinical studies and commercial use at absolute competitive prices, worldwide. We view cooperation in the sense of a long-term and close partnership with our customers - providing responsiveness, flexibility and excellent service to reduce time to market. Therefore, we cater for their individual needs and supply customised solutions.

All employees of Arevipharma are optimally trained specialists and have long-term experience in pharmaceutical drug research. They are team players, comply with high quality standards and work committedly and performance-oriented for the development of new substances and innovative production processes. Flat hierarchies within the company ensure fast and reliable exchange of information between the laboratory, the production department and the customers. In this way even the most complex projects can be executed efficiently and promptly.

arevipharma - vi are teamplayers


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Arevipharma offers:

Great experience in a broad range of organic chemistry and sophisticated process technologies

Rapid process and analytical development with guaranteed secrecy and exclusiveness and a close cooperation with the customer Development of scalable, robust and safe laboratory processes Process optimization and production in a state-of-the-art pilot plant

Scale-up and production in highly flexible and efficient multi-purpose plants

Sieving, mixing, milling and micronizing for any desired particle size distribution

State-of-the-art analytical department and highly skilled quality assurance experts Regulatory service


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Pro d uc t i o n Size and configuration of our facilities enable the batch-wise production from several kilograms to multi-tons. All plants comply with the cGMP standard and the site is regularly FDA approved. Pilot Plant

Capacity: 3.3 m³

Pressure: 1 mbar to 25 bar

7 multi-purpose reactors of 250 and 630 l glass-lined and stainless steel

Centrifuges, several pressure filters Dryers, sieve, mill

Temperature: -20 °C to + 160 °C


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Pro d u C t i o n Multi-Purpose Plant Capacity: 140 m³

12 centrifuges, stainless-steel and hastelloy 2 filter dryers, various vacuum dryers

37 multi-purpose reactors of 1.6 m³ to 6.3 m³, glass-lined and stainless steel

Thin film distillation

Temperature: -20 °C to + 160 °C

New established finnishing area with sieves, mills, mixer

Pressure: 1 bar to 25 bar

Tank farm of 1200 m³ for 20 solvents

arevipharma - vi are flexible


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arevipharma – vi are innovative


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Pro d uc t i o n Multi-Purpose Plant for high potent compounds

Capacity: 7.5 m³

When manufacturing high potent compounds, like cytotoxics or narcotics, you need an environment protected by the latest containment technology. The rooms are isolated and air-balanced to minimize cross-contamination. Equipment and pipelines configured to facilitate efficient and thorough cleaning. We have also invested in filling technologies, solutions for preventing employee exposure and assuring in incident-free supply.

3 multi-purpose reactors from 1.6 m³ of 2.5 m³, glass-lined Temperature: -15 °C to +160 °C

Temperature controlled centrifuge with cleaning in place vacuum dryer and hermetically filling in isolator box Development laboratories IPC and QC laboratories


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Qual i t y Ma nag e m e nt Quality Unit

Quality Assurance

The Quality Unit is organised in three sections – Quality Assurance, Quality Control and Regulatory Service. The individual responsibilities and core activities are clearly defined and separated from the production. Through this, a stable and consistently high quality of our products throughout the life-cycle is ensured. Skilled employees support the daily compliance with the requirements of cGMP and the maintenance of the quality policy. They are dealing with SOPs, validation procedures, internal audits, investigation of deviations, change control, raw material supplier qualifications and any other topic from cGMP.

The quality policy of Arevipharma requires a strict compliance with cGMP standards for the development and production of active ingredients, like 21 CFR § 210, 211 and EU GMP Guideline Part II, the requirements of international pharmacopoeias and customer demands. It also includes a system for continuous quality improvement, a preventive quality assurance and facilitates the identification and utilisation of cost-saving potentials. Arevipharma has a track record of 10 years with the FDA. All plants have been inspected by the German authority and cGMP certificates are available for all active ingredients.


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Quality Control The quality control department provides a full analytical service during the research, process development and the commercial production of the active ingredients and ensures a high product quality. This service includes:

Development of appropriate specifications and analytical test methods for raw materials, intermediates, final products and packaging materials

Characterization of compounds, impurities, metabolites and reference standards

Performance of polymorphism studies and stability tests Analytical support for every single process step

Particle-size determination Malvern Helos Sympatec, Alpine air-jet screen


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arevipharma - vi are your partner


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Regulatory Service The QC laboratories are fully equipped with the latest modern analytical technologies needed for product release to guarantee the most accurate controls. Spectroscopy Chromatography Crystallography Particle size determination Polarimeter, RC1

NMR, FTIR, UV/VIS, AAS GC, GC-MS, HPLC, HPLC-MS, TLC, IC DSC, X-ray Laser diffraction (Malvern, Helos Sympatec), Alpine Airjet Sieving, Microscop

We have compiled and submitted more than 19 Drug Master Files in more than 35 countries around the world to date. The European Department for the Quality of Medicines of the European Council has granted 7 Certificates of Suitability, 9 dossiers are under assessment. Experienced in both active ingredient development and commercial production Arevipharma supports further its customer proceed through the regulatory filing process by providing full support in the preparation and updating of regulatory documentations, like site accreditations, Type II Drug Master Files, European and Japanese Drug Master Files as well as the management with the relevant health authorities.


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Pac kag i n g an d Lo g i s t ic s Warehouse capacities: Packaging, storage and transportation of the raw materials, intermediates and products is carried out in strict correspondence with national and international regulations of the chemicals and transportation laws and complies with the GSP and cGMP regulations, which are customary in the chemicals trade.

Storage for substances:

800 pallets

Intermediary products:

250 pallets

Cold store:

80 pallets

All substances are stored according to specific batch and warehouse markings. Special materials such as narcotic substances and products, which are sensitive to climatic changes, are stored separately. Administration and logistics are supported by an electronic warehouse management system.

Narcotics:

50 pallets

Raw materials:

510 pallets

Combustible liquids:

270 pallets


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Wi t h Saf e t y a n d E nv i ro n m e ntal P rotec tion The respect and the protection of the environment, the employees and the public has become not only a legal obligation but also a market demand. Arevipharma operates plants that require approval and validation in accordance with the German Federal Emission Control Act. In order to ensure a permanently environmentally friendly and safe operation, the entire range of plants and equipment is constantly modernised according to the latest technologies. The company is committed to the principles of a circular economy. The high amount of chemical syntheses carried out at the company’s site therefore requires very specific concepts with regard to pre-

vention and reduction of waste. Where this is not possible, waste products are recycled in waste processing units, taking into account all relevant economic and ecologic factors. Waste products are not disposed off site, until all recycling options have been exhausted or ruled out. In a modern incineration plant for the processing of exhaust air, the entire, chemically polluted exhaust air from the production units is combusted. In addition, for the substitution of energy carriers, this plant offers the option to combust residual solvents or similar liquids. This plant complies with the provision of Germany’s 17th Federal Emission Control Act.


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Waste water is purified together with the communal waste water in an external biological waste water treatment plant. By using of this multi-level barrier system we can ensure that the stipulated limiting values for the discharge of waste water are adhered to and the river Elbe is not polluted. The execution of this safety and environmental protection scheme is supported by employees from all departments of the company.

arevipharma - vi are responsible


IMPre s s u m Arevipharma GmbH Meissner Strasse 35 01445 Radebeul Germany

phone fax e-Mail web

+ 49 (0) 351.8314-0 + 49 (0) 351.8314-2100 service@arevipharma.com www.arevipharma.com

Managing Directors: Dr. Helmut Schickaneder Klaus-Joachim Krauth

www.cross-media-store.de


arevipharma  

arevipharma, broschüre, quer, pharma

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