Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
PHARMASYNTEZ GROUP OF COMPANIES
PHARMASYNTEZ /
HISTORY
1997 JSC Pharmasyntez was established in Irkutsk.
1999 The first anti-TB drug Rifampicin manufacturing started
2002 Anti-TB drug Sodium para-aminosalicylate manufacturing started
2005 Production of solutions for infusion started in Ussuriysk
2
PHARMASYNTEZ /
HISTORY 3
2011 Design of a facility for antineoplastic drug manufacturing in Saint Petersburg started
2012 Production of the original antituberculosis drug Perchlozone® was launched
2013 Production of antiretroviral drugs and a wide range of antibiotics started
2014 Construction of a substance production facility started in Bratsk
PHARMASYNTEZ /
HISTORY
2015 A production facility was put into operation in Tyumen.
Antineoplastic drug manufacturing started
2017 The first stage of the Bratsk substance synthesis facility launched.
The first stage of the Saint Petersburg facility launched.
A small-tonnage production department opened in Irkutsk.
2018 Design works for the largest capital project, an Industrial and Technology Park in Usolye-Sibirskoye, started
4
PHARMASYNTEZ /
PRODUCTION CAPACITY
More than 145 products in various dosage forms: tablets, capsules, granules, solutions for infusion, solutions for injection, lyophilized products.
Annual production output is over 50 million packs.
Drugs for the treatment of tuberculosis, HIV infection, oncology diseases, type 2 diabetes, hepatitis.
Over 49% of total Russian anti-TB and 45% of antiretroviral drugs are produced by Pharmasyntez.
5
PHARMASYNTEZ /
PHARMASYNTEZ TODAY 6
Represented in all regions of Russia and CIS countries
2500 employees
19 hectares of land with manufacturing sites of total 34,500 sq.m of built-in area.
Production capacity (pcs.)Tablets 6,000,000,000
Capsules 480,400,000
Vials 126,000,000
Ampules 39,000,000
Solutions for infusion 34,000,000
Granules 16,000 kg
PHARMASYNTEZ /
➢ The Company has been ranked in the top 10 Russian pharmaceutical companies in terms of output of pharmaceuticals.
➢ The Company has been ranked in the top 3 fast-developing Russian pharmaceutical companies.*
➢ Ranked in the top 10 leading manufacturers with regard to hospital procurements.**
➢ The Company is the second among the manufacturers in Medical and Preventive Treatment Institution segment over 2018.***
*According to TECHUSPEKH National rating for 2018.
** According to Remedium Group and Association of International Pharmaceutical Manufacturers and finished product Budgetary Audit in the Russian Federation.
*** According to DSM Group for 2018.
PHARMASYNTEZ /
Finance 8
Revenue
16,713million rubles.
Profit
3,120million rubles.
2011 2012 2013 2014 2015 2016 2017 2018
Revenue and profit growth (million rubles)
profit revenue
PHARMASYNTEZ /
GEOGRAPHY 9
PHARMASYNTEZ /
GROUP OF COMPANIES
Manufacturing sites:
-Pharmasyntez (Irkutsk)
-East-Pharm (Ussuriysk)
-Pharmasyntez-Tyumen (Tyumen)
-Pharmasyntez-Nord (Saint Petersburg)
-BratskChemSyntez (Bratsk)
Research and development:
Irkutsk, Novosibirsk, Moscow, Saint Petersburg
Marketing and distribution:
- Yotta-Pharm (Vladivostok)
- Pharmasyntez-Retail (Moscow)
- Propharm(Irkutsk)
10
PHARMASYNTEZ /
MANAGEMENT 11
Vikram Singh Punia
President
PHARMASYNTEZ /
MANAGEMENT 12
Anna Elshina
Vice-president on
finance and
investments
Oleg Astafurov
Vice-president on
Government Relations
PHARMASYNTEZ /
MANAGEMENT
DMITRY FEDOROV
Vice-President on Legal
Support
13
IRINA PUNIA
Vice-President on
Construction
BENJAMIN KOVAC
Vice-President on
Business
Development
PHARMASYNTEZ /
MANAGEMENT 14
NATALYA PODLUBNAYA
Vice-President on
Commerce
NATALYA MALYKH
Vice-President on Quality
and Regulatory Affairs
OLGA GALKINA
Vice-President on
Production
PHARMASYNTEZ /
BRATSK 15
PHARMASYNTEZ /
BRATSK
Production of active pharmaceutical ingredients (APIs)
Annual production: up to 100,000 kg per year
Antineoplastic drugs: 3 lines (100-1000 g, 1-10 kg, 10-50 kg)
Anti-TB and anti-RV drugs: 2 lines
R&D Department for development of substance production technology up to 20 kg
16
PHARMASYNTEZ /
BRATSK
Equipment
Produced in Europe, India and China:
• Swiss Glascoat Equipments Ltd.
• Buchiglas.
• Julabo.
• Block.
• Zibo Taiji Industrial Enamel Co., Ltd.
1.35 hectares of land and 4,000 sq.m of built-in area.
17
PHARMASYNTEZ /
IRKUTSK 18
PHARMASYNTEZ /
IRKUTSK
Solid dosage forms (packs produced in 2016)
• Tablets - 4 lines (7,146,654)
• Capsules - 2 lines (4,177,743)
• Granules - 1 line (48,138)
Sterile dosage forms (packs produced in 2016)
• Solutions for injections- 1 line (2,337,109)
• Sterile powders for solutions for injection- 2 lines (1,036,056)
19
PHARMASYNTEZ /
IRKUTSK
2015 GMP-0016-00083/15 certified
2016 ISO 9001:2008, GOST ISO 9001:2011 certified
2017 A new Romaco filling and packaging line and small-scale production department was put
into operation.
Investments: 5.5 bln RUB.
New equipment manufactured by Glatt, Rommelag, Alexanderwerk, Romaco (Germany), GF,
Cosmec (Italy), Atlas Copco (Belgium), ACG Pam Pac, Neomachin (India) was installed.
20
PHARMASYNTEZ /
IRKUTSK
Research and development center
Engaged in production of all finished formulations, including pre-filled syringes and cartridges:
• aimed at developing innovative and generic products;
• searching for new molecules for the treatment of tuberculosis and HIV-infection as well as
oncology diseases;
• investments: 500 million rubles per year.
21
PHARMASYNTEZ /
SAINT PETERSBURG 22
PHARMASYNTEZ /
SAINT PETERSBURG
The plant is engaged in production of antineoplastic drugs and 7 high expensive nosologies
Investments: 2,500,000,000 rubles
Novoorlovskaya Special Economic Zone
3,970 sq m of built-in area, 800 sq m of clean rooms
Designed and constructed in accordance with GMP standards
23
PHARMASYNTEZ /
SAINT PETERSBURG
Fully automated isolated line for manufacturing of aseptic solutions and
lyophilized products with the fill-finish technology applied:
• hydrogen peroxide sterilization,
• stationary reactor or single-use reactor,
• freeze dryer with automatic loading and unloading,
• annual vials production capacity (million pcs.):
• 2R-10R (22.5),
• 20R (15.0),
• 50R (4.76).
24
PHARMASYNTEZ /
SAINT PETERSBURG
Robotized isolated line for filling vials, cartridges, and pre-filled syringes (PFS) with the fill-finish
technology applied:
Production of solutions and suspensions.
Annual production capacity:
• vials 6R 18,750,000
• cartridges 3 ml 18,750,000
• PFS 41,250,000
25
PHARMASYNTEZ /
SAINT PETERSBURG
An isolated line for coated tablet, capsule,
and pellet manufacturing produced
by Cos. Mec and B&D (Italy).
3 granulation technologies:
fluid bed drying, wet and dry granulation
Annual production capacity:
200 million tablets and 200 million capsules
Blister packaging machine - 300 blister/min
26
PHARMASYNTEZ /
Tyumen 27
PHARMASYNTEZ /
TYUMEN
Designed and constructed in accordance with GMP standards
2015: investment volume: 250 mln rubles
2016: ISO 9001:2008 certified
2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified,
Launch of hormonal drug production is in the planning stage
2018: invested 3.5 billion rubles for engineering and development of the plant.
Free capacity is available for contract manufacturing.
28
PHARMASYNTEZ /
TYUMEN
Solutions for infusion and injection
1 line for production of solutions for infusion and injection:
6 million glass vials per year.
Vial volume: 10, 50, 100, 250, 500 mL.
2 lines for production of solutions for infusion:
14 million plastic bottles per year
Bottle volume: 100, 200, 250, 400, 500 mL.
29
PHARMASYNTEZ /
TYUMEN
Solid dosage form line
Tablets:
• 6-12 mm flat-faced and biconvex tablets;
• Capsule-shaped, elliptical tablets;
• Annual production: 3 billion.
Possibility of marking tablets and capsules.
Capsules (powder/pellets):
• Dimensions: 00,0,1,2;
• Annual production: 500 million.
30
PHARMASYNTEZ /
TYUMEN
Equipment:
• Romaco and Famar fully automatic
packaging line
• 2 Niro-Automatic Rapid Mixers-
granulators
• SeJong Compression Machine
• Niro-Automatic Fluid Bed Dryer
• GS Couter (film coating, sugar coating)
• Rommelag Bottlepack system
• GF Bottling line (glass)
31
PHARMASYNTEZ /
USSURIYSK 32
PHARMASYNTEZ /
USSURIYSK
Manufacturing of large volume parenteral drugs (solutions for infusion)
Designed and constructed in accordance with GMP standards.
• blood substitutes,
• antibacterial products,
• antifungal products,
• hemostatic products,
• small-volume drugs for infusion therapy.
33
PHARMASYNTEZ /
USSURIYSK
Infusion manufacturing based on Bottlepack technology Blow-Fill-Seal :
• 50-500 mL polyethylene bottles,
• direct bottling and sealing of caps using a fully automated equipment manufactured by
Rommelag AG (Switzerland),
• filters cascade manufactured by Pall and Millipor,
• 2 Blow-Fill-Seal production lines with capacity of 20,000,000 vials per year.
Regular expansion and modernization of the manufacturing site.
34
PHARMASYNTEZ /
MARKET ACCESS SERVICES
• Full services for pharmaceutical production in Russia
• Preclinical studies (in vitro, in vivo) management.
• Clinic studies management.
• Products approval.
• Market access and governmental budget tenders.
35
PHARMASYNTEZ /
CONTACTS
Address: Irkutsk, 664007, Krasnogvardeyskaya st., 23, office 3.
Tel. +7 3952 550-355
E-mail: [email protected]
Tel. for calls within Russia: 8-800-100-15-50
36
PHARMASYNTEZ /
CONTACTS
Address: Russia, Moscow, 123100, Presnenskaya nab., bld. 12, Federation Tower (West), 42
floor.
Tel. +7 495 750-54-37
E-mail: [email protected]
www.pharmasyntez.com
37