PRODUCTION

PRODUCTS

DEVELOPMENT

Main and auxiliarylines

Тechnical facilities

Up-to-date technologies

Dosage forms

R&D

Labs

Pharmaceuticalcompany Solopharm

CONTRACTMANUFACTURING

2 3

Purchase of land

Production start of IV solutions and injections (BFS)

Premises constructionand equipmentinstallation

Production startof ophthalmic bottlesand BOV aerosols

Building commissioning

3rd stage expansionproject

2010 20142012 20152013 2016

SOLOPHARM COMPANYMeeting the requirements of Russian population in high quality medicine at affordable price

OUR PARTNERSOur partners are leading European and Russian companies with longstanding experience in supply of pharmaceuticalequipment, design and validation of pharmaceutical plants

Bausch+Ströbel (Germany) – pre-filled syringe machines, multidose filling lines

Brevetti Angela (Italy) – BFS SYFPAC® lines

Daldrop+Dr.Ing.Huber (Germany) – clean rooms for 2nd and 3rd stages

Spami (Italy) – inspection machines

Fedegari (Italy) – sterilizers

LAST (Italy) – sterilizers

D/g consultans GmbH (Germany) – technological design of for 2nd and 3rd stages

Olsa (Italy) – reactors

CAM (Italy) – cartoning and blister machines

Rommelag (Germany) – BFS bottelpack® lines

Rota (Germany) – glass ampoule filling lines

Solmatic (Poland) – line for BOV aerosols

Stilmas (Italy) – water treatment systems

Pester (Germany) – end-of-line packaging

- meeting GMP standards

- optimal location of facilities in Saint-Petersburg on the territory of 3,7 ha

- modern European up to date equipment

- sophisticated manufacturing technologies: Blow-Fill-Seal (BFS) and Bag-On-Valve (BOV)

- full range of drug development – from idea to technology introduction

- R&D laboratory

- variety of manufactured products

- unique dosage forms, preservative free

- manufacturing capability of 1 billion product units per year

Solopharm is the largest pharmaceutical company,Russian leader in liquids manufacturing

OUR ADVANTAGES:

4 5

MAIN FILLING LINESSolopharm is the largest commercial scale BFS manufacturer in Russia

MAIN FILLING LINESHigh-tech equipment and machinery allow to produce more than150 000 product units per hour

Model: 324

Manufactured by Rommelag

Product type: BFS container,Polyflac

Dosage form (ml): 100/250/500

Output (pcs/h):

Model: SVP 40

Manufactured by Brevetti Angela

Product type: unidose,Polytwist ampoule

Dosage form (ml): 0,5/1/2/5/10

Output (pcs/h):

Model: FVF 5061

Manufactured by Bausсh & Strobel

Product type: multidose

Dosage form (ml): 5/10/15

Output (pcs/h):

Model: SFM 5110

Manufactured by Bausсh & Strobel

Product type: pre-filledsyringe

Dosage form (ml): 1/2,25/3/5

Output (pcs/h):

Model: 460

Manufactured by Rommelag

Product type: Polytwist ampoule

Dosage form (ml): 5/15

Output (pcs/h):

Model: 460

Manufactured by Rommelag

Product type: Polytwist ampoule

Dosage form (ml): 5/10

Output (pcs/h):

Model: LVP 10

Manufactured by Brevetti Angela

Product type: BFS container,Polyflac

Dosage form (ml): 250/500

Output (pcs/h):

Model: R 911/MA-G

Manufactured by Rota

Product type: glass ampoule

Dosage form (ml): 1/2/5/10/20

Output (pcs/h):

Model: 360

Manufactured by Rommelag

Product type: BFS container,Polyflac

Dosage form (ml): 250/500/1000

Output (pcs/h):

Model: LVP 10

Manufactured by Brevetti Angela

Product type: BFS container,Polyflac

Dosage form (ml): 250/500

Output (pcs/h):

Model: K400/A

Manufactured by Rota

Product type: glass ampoule

Dosage form (ml): 1/2/5/10

Output (pcs/h):

Model: LVP 10

Manufactured by Brevetti Angela

Product type: BFS container,Polyflac

Dosage form (ml): 250/500

Output (pcs/h):

Model: LVP 10

Manufactured by Brevetti Angela

Product type: BFS container,Polyflac

Dosage form (ml): 250/500

Output (pcs/h):

Model: K400/A

Manufactured by Rota

Product type: glass ampoule

Dosage form (ml): 1/2/5/10

Output (pcs/h):

OSCAR

CLARA / VESTA

ALEXA

EVA

ROSETTAROSA

TROY

HANNA

REKS

FABIO

LINA

DIRK

DIEGO

SIRENA

2 500

12 500

9 000

5 000

20 00020 000

2 500

3 000

2 500

2 500

24 000

2 500

2 500

24 000

Model: PT-52 BOV

Manufactured by Solmatic

Product type: BOV aerosol

Dosage form (ml): 50/125/150

Output (pcs/h):

BERTA I / BERTA II

600

Model: K-120TS-P

Manufactured by Rota

Product type: nasal spray

Dosage form (ml): 5/10/15/30

Output (pcs/h):

EUANTHE

6 000

6 7

AUXILIARY FILLING LINESSophiisticated auxiliary filling lines of Solopharm are used for lab tests, additional sterilization, test batches and clinical studies

CLEAN ROOMS. AIR HANDLING SYSTEMGMP-compliant Solopharm facilities are designed to maintain clean and hygienic manufacturing environmentand prevent the risk of contamination

Model: EDM3295

Manufactured by Bausсh & Strobel

Product type: universal filling

Dosage form (ml): lab

Output (pcs/h):

Model: SVP100

Manufactured by Bausсh & Strobel

Product type: cartridge / pre-filled syringe

Dosage form (ml): lab

Output (pcs/h):

Model: HF916

Manufactured by Rota

Product type: universal filling

Dosage form (ml): lab

Output (pcs/h):

ERIK SILVER

DIP

750 750

750

Model: HF916

Manufactured by Rota

Product type: universal filling

Dosage form (ml): lab

Output (pcs/h):

CHIP

750

Pharmaceutical Clean Rooms are designed and installed with unique airlock complex and special ventilation system which includes 20 subsystems with separate AHUs.

In order to ensure proper conditions, supply air passes through the multi-stage filtration system.SOLOPHARM EQUIPMENT:

For today Solopharm equipment is 22 up-to-date production lines with high automation level of filling in polypropylene containers, polyethylene and glass ampoules, unidoses, aerosols, multidoses, sprays, pre-filled syringes and glass cartridges.

The facilities are equipped with advanced heating, ventilation and water treatment systems. They are the key that enable to automate the manufacturing processes and minimize the risk of microbial contamination in products.

Total clean room area(production and laboratory zone)– 6 785 m2

Capacity of clean room air handling units– 606 140 m3/h

Total area of makeup air zone– 7 730 m2

Total capacity of AHUs– 743 374 m3/h

CLEAN ROOMS

AIR HANDLING SYSTEM

8

Total surface area 21 500 m2

Total output of filling lines1 017 200 000 units per year

Cooling centre capacity19,02 mWatt

Total steam supply17,4 t/h

Total installed electric power3 149 kWatt

WATER TREATMENT SYSTEMWater treatment and solution preparation systems are supplied by Italian manufacturers Stilmas and Olsa

TECHNICAL DATASolopharm facilities are located in Saint-Petersburg on the territoryof 3,7 ha close to Saint-Petersburg Ring Road and seaport

Purified water is pre-treated with a reverse osmosis unit, while multi column distillation unit is applied to produce water for injection (WFI).Water quality is constantly controlled with the built-in automatic conductometer. In case of poor quality, water is ejected out of the system through the automatic drain valve.

Sterile solution preparation is carried out in the tanks equipped with manholes, mixers and blenders, sample collectors, CIP/SIP stations and material supply system.

Solution preparation areas are equipped with 30 tanks both mobile and stationary with maximum capacity of 30 000 l.

Product sterilization is carried out in pass-through autoclaves with control system and sterilization tracking module using superheated water.

TANKS AUTOCLAVES

PACKAGING EQUIPMENT

Water treatment capacity:

water for injection (WFI) 12 000 l/h

purified water 15 000 l/h

water treatment consumption1,1 Mio litres per day

WATER TREATMENTSYSTEM

SOLOPHARM COMPANY

Number:

Number of packaging lines:

Number:

Volume (l):

Output (pcs/h):

Volume (pallets):

38

15

7

314 000

185 000

72

11

«Blow-Fill-Seal»

BFS TECHNOLOGY BOV TECHNOLOGY

«Bag-On-Valve»

CONVENIENCERELIABILITY

STERILITY

SAFETY

SAFETY

PROFITABILITY

Equipped with a unique spray actuator

Controlled spraying pattern at all angels

Effective flushing time

Break-proof packaging

Filling of sterile components is carried out in classified clean rooms

Аbsolutely sterile during all time of use

Critical cycles are carried out in sterileclosed zone, grade A

Contamination is excluded

Total separation of product and propellant

Low production costs

The BOV technology allows the solution to remain separate from the propellant at all times,maintaining the integrity and sterility of the product. Since a BOV aerosol functions equally good at all angles it is easy to use

Тhe BFS process involves molding from plasticgranules (PP and PE), aseptic filling, and hermeticsealing in one sequential operation

BFS technology( Blow-Fill-Seal )

BOTTLESPOLYFLAC BFS

DOSING AEROSOLS(MDI)

DOSING SPRAYS(PUMP+ BOTTLE)

SYRUPBOTTLES

TECHNOLOGIES:

UNIDOSES BFS

SPRAYS(PUMP + BOTTLE)

DOSING DROPS (PUMP + BOTTLE)

CONTAINERS(POLYETHYLENE)

PRE-FILLEDSYRINGES

12 13

DOSAGE FORMSThe broadest variety of Solopharm products is presented with different dosage forms

CARTRIDGES(GLASS)

BOV AEROSOLS

50 ml / 150 ml1 ml / 2,25 ml / 3 ml / 5 ml

0,5 l / 1 l / 3 l / 5 l / 10 l

5 ml

1,8 ml

10 ml / 15 ml / 20 ml / 30 ml

10 ml / 15 ml

0,5 ml / 1 ml / 2 ml

50 ml / 100 ml / 125 ml / 150 ml

100 ml / 200 ml / 250 ml /400 ml / 500 ml / 1000 ml

Material: polyethyleneMaterial: glass

MINI MULTIDOSES(BOTTLES)

5 ml / 10 ml / 15 ml / 30 ml

Material: polyethylene

Material: polyethylene

100 ml / 150 ml

Material: glass Material: polyethylene

Material: glass

Material: polyethylene

AMPOULES (GLASS)

1 ml / 2 ml / 5 ml / 10 ml

Material: glass

Material: aluminum

Material: polyethylene

Material: aluminum

Material: polypropylene

Material: polyethylene

AMPOULES POLYTWIST BFS(POLYETHYLENE)

DOSING SPRAYS(GLASS)

MAXI MULTIDOSES(BOTTLES)

30 ml 1 ml / 2 ml / 5 ml / 10 ml50 ml / 60 ml / 100 ml / 120 ml/ 250 ml / 450 ml

Material: glass Material: polyethylene

MINI MULTIDOSES(GLASS BOTTLES)

10 ml / 15 ml / 30 ml

Material: glass

BOV technology( Bag-On-Valve )

IV BOTTLES(GLASS)

50 ml / 100 ml / 250 ml / 500 ml

Material: glass

Pharmaceutical company Solopharm produces medicines in 18 different dosage forms, using high quality materials.

Due to advanced technical facilities and high level of process automation Solopharm production runs non-stop 24 hours a day and 365 days per year.

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R&D DEPARTMENTLaboratories are equipped with all necessary tools and equipment required for quality control of raw materials

and finished products, in-process control

R&D LAB

Study of stability of new medicines and substancesamples

Development of control methods and its validation

Development of preparation technologyand its scaling

RESEARCH DEVELOPMENT

HPLC

Lab refrigerator

Osmometer

Rotational rheometer

Shimadzu LC-20 ProminenceQuantity: 5 units

Liebherr LKPv-1420Сertified storage area of finished products and substance samples for stability tests

KNAUER «Osmometer K-7400»

Anton Paar RheolabQC

R&D provides the full range of drug development – from idea to technology introduction

LABS. QUALITY CONTROLModern laboratories allow to implement quality control procedures for the finished products

ANALYTICAL LAB

Modern methods of analysis are applied to ensure quality of raw materials and finished products:

High performance liquid chromatography

Gas-liquid chromatography

IR spectroscopy

Ultraviolet–visible spectroscopy

Flame photometry

Polarimetry

Refractometry

Ionometry

MICROBIOLOGICAL LAB

Bacterial endotoxins test To detect or quantify endotoxins from Gram-negative bacteria

Sterility test and Microbiological purity testControl of substances, excipients to meet specification requirements, investigation of breakdown products, residual solvents or other process related impurities, microbial contamination

Microbiological environmental monitoring Monitoring for microbial (bacteria, viruses) and particulate contamination in sterile manufacturing rooms including all surfaces and equipment used, air and staff

Automatic polarimeterAP-300

Portable refractometerReflecto 30GS

Binder chamber

Automatic titrator Т50

Particle counter

Gas chromotographer

HPLC

Refractometer

Conductivity meter plus InLab 741-ISM

SpectophotometerUV-1800 Shimadzu

124028 N

LYJ 42C01

EQUIPMENT MODEL MANUFACTURER DESCRIPTION

KBF 115

В311122583

LIQUILAZ-E20P

7890В GC

Agilent 1260Shimadzu LC-20

ИРФ-454 Б2М

Seven CompactS230 B426738985

A1163527189 US

Atago CO., LTD

Mettler Toledo

BINDER

Mettler Toledo

Particle measuringsystems

AgilentTechnologies

Agilent TechnologiesShimadzu

InterLab

Mettler Toledo

Shimadzu

To measure the angle through whichthe ray of polarised light is diverted

To measure the index of light refraction

Thermostating, stability testing

Nonaquaeous titration

To measure particles in various size ranges

Gas chromatography (GC)

High perfomance liquid chromatography

To measure the index of light refraction

To measure pH and electrical conductivity

To determine the respective concentrationsof solutions, to identify components

Pharmaceuticalcompany Solopharm

Industrialny pr. 71, building 2, lit. ASt. Petersburg, Russia, 195279Tel.: +7 (812) 385-47-87 ext. 788 / Fax: +7 (812) 385-47-88contract@grotexmed.comwww.solopharm.com

CONTRACTMANUFACTURING