company presentation - arevipharma€¦ · company presentation . ... high potent plant pilot plant...

Company Presentation

AREVIPHARMA GERMANY 2017 | 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


ORGANIZATION

Managing Director Dr. H. Baumann

Marketing

Business Development

Process Development

Marketing & Sales

Production

Production

Environment/ Safety

Logistics

Quality

Quality Control

Quality Assurance

Regulatory Affairs

Finance/ HR

Site Development

Technology

Production Planning

Procurement

Administration/ Finance


ORGANIZATION

140 FTE Marketing & Sales / Development

Finance & HR

Quality

Production

40 university graduates

10 PhD

43,5 y average age

21 y average job tenure

14

23

29

74


KEY FIGURES

own products 80%

CMO 20%

Europe (other) 37%

USA 1%

Asia 2%

Germany 60%

narcotics 25%

Regular API 75%


1874 Foundation of the production site by von Heyden (salicylic acid)

1961 – 1990 Arzneimittelwerk (“drug factory”) Dresden (AWD) (development/production/FDF)

1991 – 2007 Degussa / Hexal / Novartis pharmaceutical production

since 2007 Arevipharma GmbH

140 years of Knowledge in Chemical Production / cGMP

WHERE WE COME FROM


Basic Chemicals

Complex Fine Chemicals

Regulated Starting Material

Advanced Intermediates

Finished Dosage Form

Studies with Patients

Active Pharmaceutical Ingredients

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

High Quality Chemistry cGMP

OUR BUSINESS MODELL


OUR PRODUCT PORTFOLIO

Active Pharmaceutical Ingredients | Focus Products

NARCOTIC APIs

Amfepramon Hydrochloride/ Diethylpropione Hydrochloride CAS 616-91-1 (USP)

Buprenorphine * CAS 52485-79-7 (PhEur, USP)

Buprenorphine Hydrochloride * CAS 53152-21-9 (PhEur,USP)

Fentanyl * CAS 437-38-7 (PhEur)

Fentanyl Citrate * CAS 437-38-7 (PhEur)

Hydromorphone Hydrochloride* CAS 71-68-1 (PhEur)

Oxycodone Hydrochloride * CAS 124-90-3 (PhEur, USP)

Remifentanil Hydrochloride * CAS 132539-07-2 (PhEur, IHS)

Tilidine Hydrochloride Hemihydrate * CAS 27107-79-5 (PhEur)

REGULAR APIs

Amiodarone Hydrochloride CAS 19774-82-4 (PhEur)

Bisoprolol Fumarate CAS 104344-23-2 (PhEur, USP)

Carbamazepine CAS 298-46-4 (PhEur)

Carvedilol CAS 72956-09-3 (PhEur

Cetirizine Dihydrochloride CAS 83881-52-1 (PhEur)

Dimethylfumarate CAS 624-49-7 (IHS)

Ebastine CAS 90729-43-4 (PhEur)

Ketamine Hydrochloride CAS 1867-66-9 (PhEur, USP)

Memantine Hydrochloride CAS 41100-52-1 (IHS)

Moxonidine CAS 75438-57-2 (PhEur)

Phenprocoumon CAS 435-97-2 (IHS)

Pyridostigmine Bromide CAS 101-26-8 (PhEur)

Sotalol Hydrochloride CAS 959-24-0 (PhEur)

Sultiame CAS 6156-3 (PhEur)

Torasemide CAS 56211-40-6 (PhEur, USP)

* Controlled Substance in Germany


OUR SITE

Arevipharma Owns Three Production Units - and Builds Two More

Multi Purpose Plant (Multi Ton Production)

High Potent Plant (Multi Kilogram Production up to OEL 4 - Products)

Pilot Plant (Multi Kilogram Production)

Pilot Plant up to OEL 4 (Multi Kilogram Production)

starting in Q4/2017

Kilo Lab (Small Volume Production)

starting in Q3/2017


PRODUCTION

Multi Purpose Plant

High Potent Plant Pilot Plant Kilo Lab


PRODUCTION

Multi Purpose Plant

High Potent Plant Pilot Plant Kilo Lab

API

± 200 tons in ± 500 Batches of 35 APIs

Intermediates

± 600 tons in ± 1.500 Batches of 68 Intermediates

Chemical production

± 360 tons in ± 100 batches of chemical products

1- to 10-step syntheses

APIs with up to 10 different customer-specific

quality grades

3 shift production with 45 shift workers


PRODUCTION

Multi Purpose Plant High Potent Plant Pilot Plant

reactors 7 reactors (250 L – 630 L)

glass-lined & stainless steal

3 reactors (2,5m³) glass-lined (SiC/glass) & equipped with condenser

36 reactors (1,6m³ - 6,3m³)

glass-lined & stainless steal

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

centrifuge connected with dryer (closed discharging system)

closed containment system (air, waste, safety)

emergency shut down system packaging area

centrifuges receivers tanks various filters filter dryer (stainless steel and

hastelloy)

specialities

Bromination hydrogenation with H2, NaBH4,

LiAlH4 gaseous reactions Grignard Friedel-Crafts Cyanation handling of corrosive substances

Hydrogenation with H2 or LiAlH4 reactions with NaCN, SOCl2 or

POCl3

Reduction with NaBH4, LiAlH4, BRCN

cyanation

centrifuges dryer various filters filter dryer


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. POCl3, SOCl2, NaCN, HBr, BrCN, Methylvinylketon, Ethylchlorformiate, Epichlorhydrine, N-LOST-Derivatives

Hydrogenation with H2-gas at up to 15 bar (catalysts: Pd/C, RA-Nickel, Pt)

Oxidation (e.g. Oppenauer)

Racemat Separation

Reduction with NaBH4, LiAlH4

Reactions with gases

Ritter reaction

Strecker reaction

Suzuki Coupling

von Braun reaction

Milling, micronizing, sieving

OUR TECHNOLOGY PORTFOLIO

Technologies for Custom Synthesis

of APIs, Advanced Intermediates and other Complex Fine Chemicals


Finishing Area closed system

class 100.000 (ISO 8)

Milling, Micronizing, Sieving particle size design

measurement with malvern

Jet mill, Hammer mill, pin disk mill

vibrating sieves ø 1m

Health, Safety, Environment highly controlled incineration of waste gas and

liquid waste (incl. chlorinated solvents)

waste water evaporation

Warehouse 2000 qm storing areas

separate cooling area 2-8 °C

high security storage of controlled substances/narcotics

INFRASTRUCTURE


Quality Control/ Assurance

Quality Control of final product and IPCs

13 analysts

Analysis of 5.000 batches p.a.

60.000 test parameters

Development of 30 in-hose methods incl. full validation (ICH Q2)

cGMP, Pharmaceutical Manufacturing License

QUALITY

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


Inspections by Authorities

REGULATORY AFFAIRS

United States US FDA (2009, 2012, 2016)

Brasil ANVISA (2012, 2015)

Japan PMDA (2012)

Korea KFDA (2012)

Germany GMP inspection (2014, 2016)

US-DMF E-DMF

CEP

J-DMF

6 32 23 2

Registrations

more than 150 global DMF approvals g

(e.g. Australia, Canada, Russia, Brazil, Taiwan,

South Korea)

http://en.wikipedia.org/wiki/File:Flag_of_Europe.svg

http://upload.wikimedia.org/wikipedia/de/c/ca/Sandoz-Logo.svg


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

PROCESS DEVELOPMENT

Process Development Industrial Production Pilot Production Process R&D

Head of Process Development

Process Development

Team 3 (Chemist)

Pool of Laboratory Technicians

Process Development

Team 1 (Chemist)

Process Development

Team 2 (Chemist)


Claudia Böttcher Europe +49 351 8314-1238 [email protected]

Marketing and Sales Team:

FROM GERMANY TO THE WORLD

Carsten Schröpfer +49 351 8314-1121 [email protected]

Dr. Hendrik Baumann +49 351 8314-1124 [email protected]

Business Development:

Kerstin Dreissig Overseas, Agencies +49 351 8314-1120 [email protected]

Arevipharma GmbH Meißner Str. 35 01445 Radebeul Germany Tel: +49 351 8314-0

Fax: +49 351 8314-2100

Web: www.arevipharma.com

Mail: [email protected]

CEO:

mailto:[email protected]




http://www.arevipharma.com/


company presentation - arevipharma€¦ · company presentation . ... high potent plant pilot plant...

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