38
PHARMASYNTEZ GROUP OF COMPANIES

PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ GROUP OF COMPANIES

Page 2: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 3: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 4: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 5: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 6: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 7: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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.

Page 8: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 9: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

GEOGRAPHY 9

Page 10: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 11: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

MANAGEMENT 11

Vikram Singh Punia

President

Page 12: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

MANAGEMENT 12

Anna Elshina

Vice-president on

finance and

investments

Oleg Astafurov

Vice-president on

Government Relations

Page 13: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

MANAGEMENT

DMITRY FEDOROV

Vice-President on Legal

Support

13

IRINA PUNIA

Vice-President on

Construction

BENJAMIN KOVAC

Vice-President on

Business

Development

Page 14: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

MANAGEMENT 14

NATALYA PODLUBNAYA

Vice-President on

Commerce

NATALYA MALYKH

Vice-President on Quality

and Regulatory Affairs

OLGA GALKINA

Vice-President on

Production

Page 15: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

BRATSK 15

Page 16: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 17: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 18: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

IRKUTSK 18

Page 19: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 20: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 21: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 22: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

SAINT PETERSBURG 22

Page 23: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 24: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 25: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 26: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 27: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

Tyumen 27

Page 28: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 29: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 30: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 31: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 32: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

PHARMASYNTEZ /

USSURIYSK 32

Page 33: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 34: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 35: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 36: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 37: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is

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

Page 38: PHARMASYNTEZ GROUP OF COMPANIES · 2019-09-04 · 2016: ISO 9001:2008 certified 2017: ISO 9001:2015, GOST R ISO 9001-2015 and IQNet certified, Launch of hormonal drug production is