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Presentation title

Company
Presentation
Business meeting / Company presentation / Sibiu, Romania / May 19th,2015
Polisano Pharmaceuticals
Company profile
Set up in 2003 by Dr. Ilie Vonica, as an entirely private company
A green field project on a 33.300 m2, located in Sibiu
Main activity is manufacturing medicines for human use, at GMP standards
Perspective to be the biggest drugs manufacturer in Romania
First Romanian manufacturer of medicines for oncology therapeutic area
using production lines with isolator techniques
Research and development platform - solid and parenteral pharmaceutical forms
Company profile
Certifications
Development directions
PHARMACEUTICAL PRODUCTION – ORAL SOLID DOSAGE FORMS
ONCOLOGICAL PRODUCTION – PARENTERAL AND SOLID
RESEARCH & DEVELOPMENT CENTRE
BIOEQUIVALENCE AND CLINICAL TRIALS
Production facilities
Production site – oral pharmaceutical forms
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Solid Dosage Forms Line (tablets, film coated tablets, capsules) –
Manufacturing Authorization since 2011, GMP certified since
2013
“State of art” technology and equipment, high production capacity,
(Ulhmann, Fette, O’Hara)
Comprising - lab and pilot scale facilities
Contract manufacturing partnerships (including medicine for
clinical investigation )
Development & extension
 Extension of production facility
 Production of current solid forms
 Development of other production lines for new pharmaceutical forms
Parenterals production
Controlled production flows fully equipped with modern
technologies, including isolators, offering high
protection for the product and the personnel.
Capacities:
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Solutions ready to use - 1.000.000 vials/year
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Freeze dried solutions - 400.000 vials/year
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Prefilled syringes - 3.500.000 prefilled syringes/year
Packaging - 10.000.000 units/year
ONCOLOGICAL PRODUCTS – secondary packaging line
Parenterals
10 000 000 units/ year
Oral solid dosage forms
3 000 000 units/ year
Vials
(5-100) ml
Blisters
1 vial/carton
(1-several)/ carton
Prefilled syringes
(1 – 3) ml, glass, luer-lock
1 syringe/ blister
1 blister/ carton
Bottles
1 bottle/carton
Bioequivalence center
Clinical Unit
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5 salons with 26 beds for subjects
Inform consent room
Sampling room
Emergency room
Consultation rooms
Monitoring room
Dining/recreation room
Warehouse
Bioanalytical Laboratory
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Sample processing room
Sample analyses rooms
Freezer's room
Warehouses
Development projects
Advanced pharmaceutical research platform
Investment program with 3 development directions:
 Research centre & pilot line for antineoplastic
oral drugs
 Research centre & pilot line for antineoplastic
injectable drugs
 Research center for bioequivalent studies
Portfolio
Food Supplements - 54 FS notified in Romania
- 16 FS in pipeline
OTC medicines - 5 products registered in Romania
- 2 products under registration process
- 2 products in pipeline
RX medicines - 36 products registered in Romania
- 16 products under registration process
- 14 products in pipeline
Portfolio / Food Supplements
FS notified in Romania
Portfolio / Food Supplements
Main target areas:
Weight Loss And Weight Control
Free Radicals Neutralization
Blood Circulation
Diabetes Prevention And Control
Health Of Eyes
Urinary Tract Protection
Prevention Of Motion Sickness
Portfolio / OTC medicines
Registered in RO
Registration process ongoing - RO
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Ibuvalen Dor - film coated tablets (ibuprofen & codeine)
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Ibuvalen Flu - film coated tablets (ibuprofen & pseudoephedrine)
Portfolio / RX medicines
Registered in RO
Registration process ongoing - RO
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Ginkgo Biloba Polisano 40 mg & 80 mg - film coated tablets
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Silibina Polisano 35 mg & 150 mg - film coated tablets (silimarinum)
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Acid Acetilsalicilic Polisano 500 mg - tablets
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Acid Tioctic Polisano 600 mg - film coated tablets (Alfa lipoic acid)
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Acid Ursodeoxicolic Polisano 250 mg - capsules
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Fluorouracil Polisano 50 mg/ml - solution for injection
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Calcium Folinate Polisano 10 mg/ml - solution for injection
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Irinotecan Polisano 20 mg/ml - concentrate for solution for infusion
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Gencitabina Polisano 200 mg & 1000 mg - lyophilized powder for solution for infusion
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Sabacomb 250/100 µg per dose - pressurized suspension for inhalation
(beclometazonă & salbutamol)
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Novalgetol 500 mg/ml - solution for injection (metamizol sodic)
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Rivastigmina Polisano 4,6 mg/24 ore & 9,6 mg/24 ore - TTS
Registered in Germany
Services provided
PRODUCTION lines – pilot &
industrial scale
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Solid dosage forms
Oncology products
Ivestigational medicinal product
SECONDARY PACKAGING
line - oncology
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RESEARCH
Vials
Prefilled syringes
Blisters/bottles
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Oral solid dosage forms
Oncological products
(parenteral, oral)
ANALYTICAL
LABORATORIES
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Analytical development
Quality control
BIOEQUIVALENCE CENTER
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EU batch release
Clinical trials
Contact details
POLISANO PHARMACEUTICALS
• 156 Alba Iulia Highway, 550052, Sibiu, Romania
• Tel: +40 269 259 992
• Fax: +40 269 259 992
• E-mail: [email protected]
• www.polisano.ro
Questions ?
Thank you !

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