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1 Company Presentation
2 AREVIPHARMA WHO WE ARE German API manufacturer offering Generic APIs with a focus on narcotics and niche products Process development and custom manufacturing of APIs Custom synthesis of complex fine chemicals Our Characteristics ± 200 tons of API production per year Quality made in Germany + independent & flexible inspected by global authorities + global distribution AREVIPHARMA GERMANY
3 ORGANIZATION Managing Director Dr. H. Baumann Marketing Production Quality Finance/ HR Business Development Production Quality Control Site Development Process Development Environment/ Safety Quality Assurance Technology Marketing & Sales Logistics Regulatory Affairs Production Planning Procurement Administration/ Finance AREVIPHARMA GERMANY
4 ORGANIZATION Marketing & Sales / Development FTE Finance & HR university graduates 10 PhD Quality 29 Production 74 43,5 y average age 21 y average job tenure AREVIPHARMA GERMANY
5 KEY FIGURES CMO 20% Germany 60% Regular API 75% Europe (other) 37% own products 80% Asia 2% USA 1% narcotics 25% AREVIPHARMA GERMANY
6 WHERE WE COME FROM 140 years of Knowledge in Chemical Production / cgmp since 2007 Foundation of the production site by von Heyden (salicylic acid) Arzneimittelwerk ( drug factory ) Dresden (AWD) (development/production/fdf) Degussa / Hexal / Novartis pharmaceutical production Arevipharma GmbH AREVIPHARMA GERMANY
7 OUR BUSINESS MODELL High Quality Chemistry cgmp Basic Chemicals Complex Fine Chemicals Regulated Starting Material Advanced Intermediates Active Pharmaceutical Ingredients Finished Dosage Form Studies with Patients PROPRIETARY PRODUCTS Manufacturing of Generics Route Scouting & Process Development e.g. regulated APIs/Narcotics High Potent APIs up to OEL 4 (> 1 µg/m³) EXCLUSIVE PRODUCTS Custom Manufacturing Upscaling New Chemical Entities Generic APIs Advanced Intermediates Process Optimization, cost-effective Route-Scouting Analytical Development Regulatory Support / Registration AREVIPHARMA GERMANY
8 OUR PRODUCT PORTFOLIO Active Pharmaceutical Ingredients Focus Products NARCOTIC APIs Amfepramon Hydrochloride/ Diethylpropione Hydrochloride CAS (USP) Fentanyl * CAS (PhEur) Oxycodone Hydrochloride * CAS (PhEur, USP) Buprenorphine * CAS (PhEur, USP) Fentanyl Citrate * CAS (PhEur) Remifentanil Hydrochloride * CAS (PhEur, IHS) Buprenorphine Hydrochloride * CAS (PhEur,USP) Hydromorphone Hydrochloride* CAS (PhEur) Tilidine Hydrochloride Hemihydrate * CAS (PhEur) Amiodarone Hydrochloride CAS (PhEur) Carvedilol CAS (PhEur Ebastine CAS (PhEur) Moxonidine CAS (PhEur) Sotalol Hydrochloride CAS (PhEur) REGULAR APIs Bisoprolol Fumarate CAS (PhEur, USP) Cetirizine Dihydrochloride CAS (PhEur) Ketamine Hydrochloride CAS (PhEur, USP) Phenprocoumon CAS (IHS) Sultiame CAS (PhEur) Carbamazepine CAS (PhEur) Dimethylfumarate CAS (IHS) Memantine Hydrochloride CAS (IHS) Pyridostigmine Bromide CAS (PhEur) Torasemide CAS (PhEur, USP) * Controlled Substance in Germany AREVIPHARMA GERMANY
9 Arevipharma Owns Three Production Units - and Builds Two More OUR SITE Kilo Lab (Small Volume Production) starting in Q3/2017 High Potent Plant (Multi Kilogram Production up to OEL 4 - Products) Pilot Plant (Multi Kilogram Production) Multi Purpose Plant (Multi Ton Production) Pilot Plant up to OEL 4 (Multi Kilogram Production) starting in Q4/2017 AREVIPHARMA GERMANY
10 PRODUCTION Multi Purpose Plant High Potent Plant Pilot Plant Kilo Lab AREVIPHARMA GERMANY
11 PRODUCTION Multi Purpose Plant API ± 200 tons in ± 500 Batches of 35 APIs Intermediates ± 600 tons in ± Batches of 68 Intermediates Chemical production ± 360 tons in ± 100 batches of chemical products High Potent Plant Pilot Plant Kilo Lab 1- to 10-step syntheses APIs with up to 10 different customer-specific quality grades 3 shift production with 45 shift workers AREVIPHARMA GERMANY
12 PRODUCTION Multi Purpose Plant Pilot Plant High Potent Plant reactors 36 reactors (1,6m³ - 6,3m³) glass-lined & stainless steal 7 reactors (250 L 630 L) glass-lined & stainless steal 3 reactors (2,5m³) glass-lined (SiC/glass) & equipped with condenser temperature -20 C 160 C -60 C 200 C -10 C 160 C pressure 1 mbar 15 bar 1 mbar 15 bar 1 mbar - 6 bar equipment centrifuges receivers tanks various filters filter dryer (stainless steel and hastelloy) centrifuges dryer various filters filter dryer centrifuge connected with dryer (closed discharging system) closed containment system (air, waste, safety) emergency shut down system packaging area specialities Bromination hydrogenation with H 2, NaBH 4, LiAlH 4 gaseous reactions Grignard Friedel-Crafts Cyanation handling of corrosive substances Hydrogenation with H 2 or LiAlH 4 reactions with NaCN, SOCl 2 or POCl 3 Reduction with NaBH 4, LiAlH 4, BRCN cyanation AREVIPHARMA GERMANY
13 Technologies for Custom Synthesis OUR TECHNOLOGY PORTFOLIO of APIs, Advanced Intermediates and other Complex Fine Chemicals Aldol Condensation Alkylation / Acylation Amidation / Amination Boronic Acid Chemistry Condensation Cyanation Cryogenic reactions (pilot scale) Decarboxylation Diels-Alder reaction Esterification / Saponification Friedel-Crafts reaction Grignard reaction Halogenation (Cl, Br, I) Handling of controlled and highly potent compounds Handling of corrosive and toxic compounds, e.g. POCl 3, SOCl 2, NaCN, HBr, BrCN, Methylvinylketon, Ethylchlorformiate, Epichlorhydrine, N-LOST-Derivatives Hydrogenation with H 2 -gas at up to 15 bar (catalysts: Pd/C, RA-Nickel, Pt) Oxidation (e.g. Oppenauer) Racemat Separation Reduction with NaBH 4, LiAlH 4 Reactions with gases Ritter reaction Strecker reaction Suzuki Coupling von Braun reaction Milling, micronizing, sieving AREVIPHARMA GERMANY
14 INFRASTRUCTURE Health, Safety, Environment highly controlled incineration of waste gas and liquid waste (incl. chlorinated solvents) waste water evaporation Milling, Micronizing, Sieving particle size design measurement with malvern Jet mill, Hammer mill, pin disk mill vibrating sieves ø 1m Finishing Area closed system class (ISO 8) Warehouse 2000 qm storing areas separate cooling area 2-8 C high security storage of controlled substances/narcotics AREVIPHARMA GERMANY
15 QUALITY Quality Control/ Assurance Quality Control of final product and IPCs 13 analysts Analysis of batches p.a test parameters Development of 30 in-hose methods incl. full validation (ICH Q2) cgmp, Pharmaceutical Manufacturing License Major Equipment 24 HPLC systems Equipped with wave length, DAD, mass & corona detectors 18 GC Systems Equipped with FID,NPD, TCD, ECD & mass detectors Several injectors: headspace, on-column, cold Spectrometers 500 MHz NMR, UV-Vis, IR AAS & ICP-MS AREVIPHARMA GERMANY
16 REGULATORY AFFAIRS Registrations US-DMF E-DMF CEP J-DMF Inspections by Authorities United States US FDA (2009, 2012, 2016) Brasil ANVISA (2012, 2015) Japan PMDA (2012) Korea KFDA (2012) Germany GMP inspection (2014, 2016) more than 150 global DMF approvals g (e.g. Australia, Canada, Russia, Brazil, Taiwan, South Korea) AREVIPHARMA GERMANY
17 PROCESS DEVELOPMENT Process R&D Process Development Pilot Production Industrial Production Head of Process Development Process Development Team 1 (Chemist) Process Development Team 2 (Chemist) Process Development Team 3 (Chemist) Pool of Laboratory Technicians Main Tasks of the Process Development Upscaling of (laboratory) processes Documentation, literature- and patent check Process optimization and trouble shooting Safety check (i.e. calorimetry etc.) Development of analytical methods and validation Synthesis of reference standards and impurities AREVIPHARMA GERMANY
18 FROM GERMANY TO THE WORLD Arevipharma GmbH Meißner Str Radebeul Germany Tel: Fax: Web: Mail: CEO: Dr. Hendrik Baumann Marketing and Sales Team: Kerstin Dreissig Overseas, Agencies Claudia Böttcher Europe Business Development: Carsten Schröpfer AREVIPHARMA GERMANY
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