Contract manufacturing

Contract manufacturing

Pharmaceutical contract manufacturing

Sopharma is a leading contract manufacturer in Bulgaria for tablets (film-coated and sugar coated), capsules, injectables, gels, creams, ointments, syrups and suppositories.

Our company provides customers with a dependable, experienced and trustworthy resource for the contract manufacturing of different dosage forms.

We are a respected contract manufacturer catering to markets like Europe, Asia, Africa, and North America (the largest share in its export markets is realized in Russia, Ukraine and Poland).

Sopharma is a leading Bulgarian pharmaceutical manufacturer of branded and generic pharmaceuticals. Sopharma’s OTC and prescription drugs are well accepted in more than 40 markets due to their quality, efficiency and reasonable pricing.

We are a company with more than 80 years’ tradition and a modern approach for production of human medicines, meeting EU quality standards, and corporate social responsibility. We manufacture products up to the highest quality standards. Sopharma is a holder of EU GMP - certified manufacturing sites for different dosage forms with the assurance for high product quality.

More than 210 different products are produced by Sopharma’s pharmaceutical manufacturing plants and distributed to more than 40 countries for various international partners.

Sopharma offers:

• EU-GMP compliant pharmaceutical contract manufacturing,
• EU primary and secondary packaging services for international markets
• Development of various dosage forms
• Technological transfer of customer-developed products
• Cleaning validation, Process validation
• EU batch release and batch control

Sopharma is specialized in manufacturing of solid and semi-solid dosage forms, sterile dosage forms, non-sterile liquids/solutions. These are all of which produced in specialized facilities (for suppositories, tablets, lyophilized products, ampoules, phyto-APIs manufacturing, syrups, creams, ointments and gels).

All our plants are EU GMP-certified and they are able to produce different types of packaging based on customer demands (packaging in bags, packaging in containers, packaging in AL/ PVC, AL/ PVDC, ALU/ALU blisters,  packaging in carton boxes, packaging in bottles, packaging in tubes, shippers packaging).  The plants can also handle specific packaging items like Data Matrix Code, Braille, Vignettes etc.

Sopharma offers the following contract manufacturing services:

• Contract manufacturing of tablets, film-coated tablets, sugar–coated tablets and hard-gelatin capsules  | Virtual Tour

The tablet plant has an advanced manufacturing capacity, a plentitude of technological experience and a committed and highly qualified team. We are capable of manufacturing a large variety of tablet shapes and sizes. Upon demand, customised tablet shapes can also be manufactured. Tablets can be coated according to customers’ needs, using film or sugar coatings.

Main manufacturing equipment includes fluid bed dryers, blenders, film-coating drums, high shear mixers, tablet presses – FETTE, packaging lines Uhlmann and capsule filling machine MG2 Planeta

• Contract manufacturing of sterile injectables (terminally sterilized injectables and aseptically prepared injectables)
• Blow-Fill-Seal Line is fully operational from 2015 year

At any stage of the production, from the filling to the packaging, we can offer pharmaceutical contract manufacturing services for the following pharmaceutical forms: glass ampoule of 1, 2, 5 and 10 ml, 100, 250,500 and 1000 ml PP bags and 0.7÷ 500 ml BFS (blow fill seal manufacturing technology).

Main manufacturing equipment include PW installation and WFI installation, high voltage leak detection line (leak detection, pinhole and crack detection), labeling lines, secondary packaging lines.

Terminal sterilization: Washing-depyrogenization-filling-sealing line, Steam sterilization module, vessels
Aseptic preparation: Washing-depyrogenization-filling-sealing line, Aseptic sterilization module, vessels
Lyophilized products: PW and WFI installation lines, vessels, lyophilizer, autoclaves

• Contract manufacturing of suppositories

We offer suppository products of high quality at economical prices in bilayer PVC/PE packs.
Main manufacturing equipment include homogenizers, vessels, filling and packaging line

• Contract manufacturing of non-sterile dosage forms (solutions)

Sopharma offers non-sterile dosage forms (syrups) in a variety of final packages, including PET and glass bottles.
Main manufacturing equipment includes vessels, primary and secondary packaging lines

• Contract manufacturing of semisolid dosage forms

Our plants are able to manufacture different topical products (creams, ointments and gels).

Main manufacturing equipment includes vessels, homogenizer, filling and packaging line for Al and laminate tubes with filling head for 5 ÷ 150 ml and tube holders with a 20 mm diameter.

The capability of our organization and its facilities capacity is a quarantee for a high quality affordable product in a timely manner.

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For additional information, please contact us:

Ana Lichkova
Manager Contract Manufacturing and New Products
Е-mail: alichkova@sopharma.bg
 

Contract manufacturing of solid dosage forms

ABOUT THE PROJECT

The project for the new technology factory for solid dosage forms is built in accordance with European requirements for Good Manufacturing Practice and ensures control and easy traceability of the manufacturing process at every stage.

The value of the project amounts 75 million BGN, of which 3.9 million BGN were provided by an European project on competitiveness.

The new plant for solid dosage forms will produce over 80 products from major pharmaceutical groups: cardio-metabolic, neurological, psychiatric, respiratory products and OTC products - analgesics and antipyretics. Sopharma is a well-established company in the pharmaceutical industry with 80 years of experience in the production of sterile (injectable, infusion, and lyophilic) forms, liquids, suppositories and semi-solid dosage forms.

TECHNOLOGIES

In order to create pure product one must ensure a clean environment. Without using the specific terminology, we can say that it is created in order to protect the product, to protect the people and to protect the product from the people.

The plant consists of two main buildings. The first unit is the manufacturing workshop, which for the most part has two floors. On the first floor is located the manufacturing and on the second floor – the technological equipment, which serves the production processes taking place underneath. The second unit is the laboratory and office complex.
At project level the management of processes that consume energy takes into consideration the subsequent costs depending on the workload of production. Practically, the 

BMS regulates the system so that the workshop consumes only as much energy as is needed to maintain optimal settings at any time. Furthermore, the BMS manages all the parameters and backs up the data, so that the parameters in any room can be checked against any moment in the past. 

The technological process requires certain parameters for the production of the product at different stages, for example a constant temperature of 22 + / -1 ° C, a pressure differential between the premises and the corridors, different humidity below 30%, or between 30 and 60% depending on the product. The BMS manages the various systems, so as to maintain the parameters set by the technologists. For example, the requirements for a clean environment are 100 000 particles with a size of 0.05 microns in 1 cubic meter, whereas in the environment are between three and five million. Around 200,000 cubic meters of air are processed per hour. They do not simply pass, but are also filtered, cooled or heated, depending on the temperature and season.

The movement of materials and products takes place by using special dedusting systems which are for loading and transferring. Here the objective is to produce large volumes, to have absolute consistency in each subsequent step, an absolute uniformity of the product, while protecting the environment.

The new plant uses both purified and drinking and industrial water. Since the process that requires the use of the largest amount of water is washing the machines, through the facilities it is executed by a WIP (purified water) system, which, compared to manual hand washing, saves a lot of water and ensures a quality washing of the equipment.

We are proud that our new plant will have a minimal environmental footprint. Perhaps the most important step in this direction is the repeated reduction of organic solvents used in the granulation process and filming. These organic solvents will be replaced with water ones in our new production process and thus the annual consumption of isopropanol will decrease by up to 20,000 kg and the consumption of the acetone by up to 9,200 kg. We might add also the fact that we have installed 8,000 m2 photovoltaic units which will ensure the reduction of carbon dioxide emissions by up to 900 tons per year. The air coming out of the processes first goes through HEPA filter and is then discharged into the environment.

THE PLANT IN NUMBERS

• Investment – 75 million BGN
• Capacity – 4 billion tablets yearly in a two-shift mode
• 400 jobs, of which 80% are occupied by people with higher education
• Plant for solid dosage forms – built-up area – 22 000 м²
• Laboratory and administrative complex – built-up  area – 5000  м²
• High-shelves warehouse with 4200 pallet places with an electronic systems for material management
• The air conditioning system processes around 200 000 м³ of air per hour and has 18 000 м² air pipelines. Provides a controlled working environment for the pharmaceutical production.
• The construction took 2.5 years with a full-time employment of 150 people and over 100 000 workday.
• The materials, equipment and services were contracted with over 200 Bulgarian and foreign suppliers.
• Over 120 km. of cables were used.

Contract manufacturing of semisolid dosage forms

The "Vrabevo" plant – The Bulgarian dream come true 

In 2003 the new plant of Sopharma Ad in Vrabevo was opened by the President of the Republic of Bulgaria Mr. George Parvanov.

The investments made amount to 10 million EUR and every step of the construction of the plant are carried out according to GMP standards. 

The plant is situated in the ecological area of the Troyan mountain with a total production area of 6 000 sq. m. The plant is a proof of the high social responsibility of Sopharma and provides 350 working places – a real opportunity for the local population. 

The plant has a license by the Bulgarian National Drug Agency for production of solid forms, gels, syrups and unguents.

The main medicinal products produced at the plant are in the following areas: gastroenterology, cardiology, pulmology, allergy, analgesics, antipyretic, psychopharmacological and chemotherapeutic. 

The production capacity includes:

• Solid forms: 1 billion annually
• Syrups: 20 million annually
• Unguents: 30 million annually

The plant received the award for the best production building in the national competition Building of the Year 2003 and was licensed under the provisions of EU Directive 91/356.

Manufacturing of sterile dosage forms Manufacturing of non-sterile dosage forms Manufacturing of tablets Manufacturing of film-coated tablets Manufacturing of sugar-coated tablets Manufacturing of hard-gelatin capsules Manufacturing of sterile injectables Manufacturing of suppositories Manufacturing of syrups Manufacturing of creams Manufacturing of ointments Manufacturing of gels.

Manufacturing of sterile dosage forms

Sopharma has capacity and experience to meet a range of sterile injectable contract manufacturing needs.
Sopharma is specialized in manufacturing of sterile dosage forms:

• terminally sterilized injectables
• aseptically prepared

At any stage of the production, from the filling to the packaging, we can offer pharmaceutical contract manufacturing services for the following pharmaceutical forms: glass ampoule of 1, 2, 5 and 10 ml and 0.7÷ 500 ml BFS (blow fill seal manufacturing technology).


Ampoule plant

Main manufacturing equipment includes:

• PW installation with capacity up to 6 t/h
• WFI installation (used jointly with the lyophilized products plant) with capacity up to 1.5 t/ h
• Lines for visual inspection + High Voltage Leak Detection(leak detection, pinhole and crack detection):
  • AIM 277+Convel:  Bosch Eisai + Convel, 2014
  • AIM 296 + Nika: Eisai, 2007 + Bausch & Strӧbel / Nikka Densok , 2007
  • AIM 296 + KLD: Eisai, 2015 + Bosch, 2015

• Labeling lines Newman 6VA and Newman VAL 550
• Secondary packaging lines:
  • Mediseal, 2015
  • Soteco , IMA Group
• Box coding UDA 150S, Metronic

Main manufacturing equipment with terminal sterilization includes:

• Vessels, Schrader, capacity 20 l, 50 l, 100 l, 250 l
• Washing-depyrogenization-filling-sealing line ALF (RRU+HQL+ALF) , Bosch 2015 for 1, 2, 5 and 10 ml glass ampoules; capacity 1&2 ml– 24 000 units/ h
• Washing-depyrogenization-filling-sealing line line AVR (RUR+TLQ+AVR) , Bosch 2007, capacity 2 ml glass ampoules – 6 ÷ 16 000 units/ h; 5 ml – up to 12 000 units/ h; 10 ml – up to 9 000units/h
• Steam sterilization module GEL 91425, Getinge, 3000 l

Main manufacturing equipment with aseptic preparation includes:

• Vessels, capacity 100 l, 300 l
• Washing-depyrogenization-filling-sealing line АLF (RRU+HQL+ALF) , Bosch 2007, capacity 1&2ml glass ampoules – up to 24 000 units/ h, 5 ml -up to 15 000 units/ h; 10ml -up to 9 000 units/ h
• Aseptic sterilization module GE 6613 , Getinge, 500 l & GEL 91425 , Getinge, 3000 l

Lyophilized products Plant

Main manufacturing equipment includes:

• PW Installation, Aqua PW System
• WFI Installation, Gettinge Kemiterm
• Vessel Buchi – 15 l, equipped with dosing device, cryostat, pH-meter, thermocouple
• Vessel, Steridose, capacity 50 l
• Lyophilizer, Leybold

Manufacturing of non-sterile dosage forms

Sopharma offers non-sterile dosage forms in a variety of final packages, including PET and glass bottles.

Our range of services offers syrups contract manufacturing.

Main manufacturing equipment includes:

• Vessel Steridose 2 800 l
• Vessel Rotamil 1 000 l
• Homogenizer  ROMACO FrymaKoruma  with capacity 100 l /min suspension
• Primary packaging line Marchesini ML 661
• Secondary packaging line Marchesini MA100

Manufacturing of tablets

Sopharma is specialized in manufacturing of tablets

• Manufacturing of film-coated tabletS
• Manufacturing of sugar-coated tablets
• Manufacturing of hard-gelatin capsules

In the world of tablet manufacturers, there is a lot of disagreement about what makes a company a quality manufacturing company. For us, the key to becoming the best manufacturer is a dedication to the customer’s needs.  In addition, the best tablet manufacturers are those that can provide you with sensible services at a reasonable and enough competitive cost. That would be us. We can help you to improve profits and lower overhead.

Our facilities offer a complete process that extends from sieving, granulation, compression and coating to primary and secondary packaging.

Solid Dosage Forms Plant Sofia:

The Solid Dosage Forms has an advanced manufacturing capacity, a plentitude of technological experience and a committed and highly qualified team. We are capable of manufacturing a large variety of tablet shapes and sizes. Upon demand, customized tablet shapes can also be manufactured. Tablets can be coated according to customers’ needs, using film or sugar coating.

Main manufacturing equipment includes:

• Fluid bed dryers:
  • BOSCH - HUETTLIN (nominal volume 527 l) with drying capacity 50÷240 kg/ granulation capacity 50÷210 kg
  • BOSCH - HUETTLIN (nominal volume 937 l) with drying capacity 100÷490 kg/ granulation capacity 100÷375 kg

• Blenders with capacities 306 ÷1 300 l, 170÷720 l, 102÷433 l. All from L.B. Bohle Maschinen
• Film-coating drums with capacities 200÷400 kg; 90÷120 kg (Bohle and Manesty)
• High Shear Mixer (nominal volume 400 l) with capacity 65÷180 kg (BOCSH-HUETTLIN)
• Tablet presses - FETTE
• Packaging lines Uhlmann
• Capsule filling machine MG2 Planeta (capsule’s size 0÷4)

Vrabevo Plant

Main manufacturing equipment includes:

• Fluid bed dryer Glatt WSG-CD 60 with capacity 40÷120 l
• Blender Glatt KCM with capacity 40÷100 l
• Film-coating drum Glatt GCM 175 with capacity 80÷130 kg

Bulgarian Rose Sevtopolis plant

Main manufacturing equipment includes:

• Fluid bed dryer Glatt WSG-UDP 60 with capacity 40÷100 l
• Blender with capacity 40÷100 l, 80÷200 l, 225÷600 l
• Film-coating drums :
  • Glatt  GC 1250 with capacity 80÷150 kg
  • Glatt  GC 1500 with capacity 200÷340 kg
  • Technicota 400 with capacity 200÷340 kg

• High Shear Mixer Fielder RMA 400/ 261 VAC with capacity 80÷140 kg
• Capsule filler Macofar MT 80 (capsule’s size 0÷4)

Manufacturing of film-coated tablets

Sopharma is a leading Bulgarian manufacturer of solid dosage forms, especially film-coated tablets. We provide our customers with a dependable, experienced and trustworthy resource for the contract manufacturing of film-coated tablets. Our production has been well accepted both by the local and the export markets (the largest share of exports being Russia, Ukraine and Poland).

Manufacturing of film-coated tablets

In the world of tablet manufacturers, there is a lot of disagreement about what makes a company a quality manufacturing company. For us, the key to becoming the best manufacturer is a dedication to the customer’s needs.  In addition, the best tablet manufacturers are those that can provide you with sensible services at a reasonable and enough competitive cost. That would be us. We can help you to improve profits and lower overhead.

Our facilities offer a complete process that extends from sieving, granulation, compression and coating to primary and secondary packaging.

Solid Dosage Forms Plant Sofia:

The Solid Dosage Forms has an advanced manufacturing capacity, a plentitude of technological experience and a committed and highly qualified team. We are capable of manufacturing a large variety of tablet shapes and sizes. Upon demand, customized tablet shapes can also be manufactured. Tablets can be coated according to customers’ needs, using film or sugar coating.

Main manufacturing equipment includes:

• Fluid bed dryers:
  • BOSCH - HUETTLIN (nominal volume 527 l) with drying capacity 50÷240 kg/ granulation capacity 50÷210 kg
  • BOSCH - HUETTLIN (nominal volume 937 l) with drying capacity 100÷490 kg/ granulation capacity 100÷375 kg
• Blenders with capacities 306 ÷1 300 l, 170÷720 l, 102÷433 l. All from L.B. Bohle Maschinen
• Film-coating drums with capacities 200÷400 kg; 90÷120 kg (Bohle and Manesty)
• High Shear Mixer (nominal volume 400 l) with capacity 65÷180 kg (BOCSH-HUETTLIN)
• Tablet presses - FETTE
• Packaging lines Uhlmann
• Capsule filling machine MG2 Planeta (capsule’s size 0÷4)

Vrabevo Plant:

Main manufacturing equipment includes:

• Fluid bed dryer Glatt WSG-CD 60 with capacity 40÷120 l
• Blender Glatt KCM with capacity 40÷100 l
• Film-coating drum Glatt GCM 175 with capacity 80÷130 kg

Bulgarian Rose Sevtopolis plant:

Main manufacturing equipment includes:

• Fluid bed dryer Glatt WSG-UDP 60 with capacity 40÷100 l
• Blender with capacity 40÷100 l, 80÷200 l, 225÷600 l
• Film-coating drums :
  • Glatt  GC 1250 with capacity 80÷150 kg
  • Glatt  GC 1500 with capacity 200÷340 kg
  • Technicota 400 with capacity 200÷340 kg

• High Shear Mixer Fielder RMA 400/ 261 VAC with capacity 80÷140 kg
• Capsule filler Macofar MT 80 (capsule’s size 0÷4)

Manufacturing of sugar-coated tablets

Sopharma is a leading Bulgarian manufacturer of solid dosage forms, especially sugar-coated tablets. We provide our customers with a dependable, experienced and trustworthy resource for the contract manufacturing of sugar-coated tablets. Our production has been well accepted both by the local and the export markets (the largest share of exports being Russia, Ukraine and Poland).


Manufacturing of sugar-coated tablets

In the world of tablet manufacturers, there is a lot of disagreement about what makes a company a quality manufacturing company. For us, the key to becoming the best manufacturer is a dedication to the customer’s needs. In addition, the best tablet manufacturers are those that can provide you with sensible services at a reasonable and enough competitive cost. That would be us. We can help you to improve profits and lower overhead.

Our facilities offer a complete process that extends from sieving, granulation, compression and coating to primary and secondary packaging.


Solid Dosage Forms Plant Sofia

The Solid Dosage Forms has an advanced manufacturing capacity, a plentitude of technological experience and a committed and highly qualified team. We are capable of manufacturing a large variety of tablet shapes and sizes. Upon demand, customized tablet shapes can also be manufactured. Tablets can be coated according to customers’ needs, using film or sugar coating.

Main manufacturing equipment includes:

• Fluid bed dryers:
  • BOSCH - HUETTLIN (nominal volume 527 l) with drying capacity 50÷240 kg/ granulation capacity 50÷210 kg
  • BOSCH - HUETTLIN (nominal volume 937 l) with drying 100÷490 kg/ granulation capacity 100÷375 kg
• Blenders with capacities 306 ÷1 300 l, 170÷720 l, 102÷433 l. All from L.B. Bohle Maschinen
• Film-coating drums with capacities 200÷400 kg; 90÷120 kg (Bohle and Manesty)
• High Shear Mixer (nominal volume 400 l) with capacity 65÷180 kg (BOCSH-HUETTLIN)
• Tablet presses - FETTE
• Packaging lines Uhlmann
• Capsule filling machine MG2 Planeta (capsule’s size 0÷4)

Vrabevo Plant:

Main manufacturing equipment includes:

• Fluid bed dryer Glatt WSG-CD 60 with capacity 40÷120 l
• Blender Glatt KCM with capacity 40÷100 l
• Film-coating drum GCM 175 with capacity 80÷130 kg

Bulgarian Rose Sevtopolis plant:

Main manufacturing equipment includes:

• Fluid bed dryer Glatt WSG-UDP 60 with capacity 40÷100 l
• Blender with capacity 40÷100 l, 80÷200 l, 225÷600 l
• Film-coating drums :
  • Glatt  GC 1250 with capacity 80÷150 kg
  • Glatt  GC 1500 with capacity 200÷340 kg
  • Technicota 400 with capacity 200÷340 kg
• High Shear Mixer Fielder RMA 400/ 261 VAC with capacity 80÷140 kg
• Capsule filler Macofar MT 80 (capsule’s size 0÷4)

Manufacturing of hard-gelatin capsules

Sopharma has an advanced capacity for manufacturing of pharmaceutical products in hard gelatin capsules. Our GMP-licensed plants are able to produce different packages based on customer demands, from capsule size 0 to capsule size 4, both single color and  multicolored.


Solid Dosage Forms Plant Sofia:

The Solid Dosage Forms has an advanced manufacturing capacity, a plentitude of technological experience and a committed and highly qualified team. We are capable of manufacturing a large variety of tablet shapes and sizes. Upon demand, customized tablet shapes can also be manufactured. Tablets can be coated according to customers’ needs, using film or sugar coating.

Main manufacturing equipment includes:

• Fluid bed dryers:
  • BOSCH - HUETTLIN (nominal volume 527 l) with drying capacity 50÷240 kg/ granulation capacity 50÷210 kg
  • BOSCH - HUETTLIN (nominal volume 937 l) with drying 100÷490 kg/ granulation capacity 100÷375 kg
• Blenders with capacities 306 ÷1 300 l, 170÷720 l, 102÷433 l. All from L.B. Bohle Maschinen
• Film-coating drums with capacities 200÷400 kg; 90÷120 kg (Bohle and Manesty)
• High Shear Mixer (nominal volume 400 l) with capacity 65÷180 kg (BOCSH-HUETTLIN)
• Tablet presses - FETTE
• Packaging lines Uhlmann
• Capsule filling machine MG2 Planeta (capsule’s size 0÷4)

Vrabevo Plant:

Main manufacturing equipment includes:

• Fluid bed dryer Glatt WSG-CD 60 with capacity 40÷120 l
• Blender Glatt KCM with capacity 40÷100 l
• Film-coating drum GCM 175 with capacity 80÷130 kg

Bulgarian Rose Sevtopolis plant:

Main manufacturing equipment includes:

• Fluid bed dryer Glatt WSG-UDP 60 with capacity 40÷100 l
• Blender with capacity 40÷100 l, 80÷200 l, 225÷600 l
• Film-coating drums :
  • Glatt  GC 1250 with capacity 80÷150 kg
  • Glatt  GC 1500 with capacity 200÷340 kg
  • Technicota 400 with capacity 200÷340 kg

• High Shear Mixer Fielder RMA 400/ 261 VAC with capacity 80÷140 kg
• Capsule filler Macofar MT 80 (capsule’s size 0÷4)

Manufacturing of sterile injectables

Sopharma has capacity and experience to meet a range of sterile injectables contract manufacturing needs.
Sopharma is specialized in manufacturing of sterile dosage forms:

• terminally sterilized injectables
• aseptically prepared injectables

At any stage of the production, from the filling to the packaging, we can offer pharmaceutical contract manufacturing services for the following pharmaceutical forms: glass ampoule of 1, 2, 5 and 10 ml and 0.7÷ 500 ml BFS (blow fill seal manufacturing technology).


Ampoule plant

Main manufacturing equipment includes:

• PW installation with capacity up to 6 t/h
• WFI installation with capacity up to 1.5 t/ h

• Lines for visual inspection + High Voltage Leak Detection( leak detection, pinhole and crack detection) :

• AIM 277+Convel:  Bosch Eisai + Convel, 2014
• AIM 296 + Nika: Eisai, 2007 + Bausch & Strӧbel / Nikka Densok , 2007
• AIM 296 + KLD: Eisai, 2015 + Bosch, 2015

• Labeling lines Newman 6VA and Newman VAL 550
• Secondary packaging lines:
  • Mediseal, 2015
  • Soteco , IMA Group
• Box coding UDA 150S, Metronic

Main manufacturing equipment with terminal sterilization includes:

• Vessels, Schrader, capacity 20 l, 50 l, 100 l, 250 l
• Washing-depyrogenization-filling-sealing line ALF (RRU+HQL+ALF) , Bosch 2015 for 1, 2, 5 and 10 ml glass ampoules; capacity 1&2 ml– 24 000 units/ h
• Washing-depyrogenization-filling-sealing line line AVR (RUR+TLQ+AVR) , Bosch 2007, capacity 2 ml glass ampoules – 6 ÷ 16 000 units/ h; 5 ml – up to 12 000 units/ h; 10 ml – up to 9 000units/h
• Steam sterilization module GEL 91425, Getinge, 3000 l

Main manufacturing equipment with aseptic preparation includes:

• Vessels, capacity 100 l, 300 l
• Washing-depyrogenization-filling-sealing line АLF (RRU+HQL+ALF) , Bosch 2007, capacity 1&2ml glass ampoules – up to 24 000 units/ h, 5 ml -up to 15 000 units/ h; 10ml -up to 9 000 units/ h
• Aseptic sterilization module GE 6613 , Getinge, 500 l & GEL 91425 , Getinge, 3000 l

Lyophilized products Plant

Main manufacturing equipment includes:

• PW Installation, Aqua PW System
• WFI Installation, Gettinge Kemiterm
• Vessel Buchi – 15 l, equipped with dosing device, cryostat, pH-meter, thermocouple
• Vessel, Steridose, capacity 50 l
• Lyophilizer, Leybold
• Autoclaves – Tuttnauer

Manufacturing of suppositories

We are able to offer contract manufacturing services  of suppositories of high quality at economical prices in bilayer PVC/PE packs
The suppositories plant of Sopharma AD is another unique production in BulgariaIn the beginning of 2005 we opened the fully renovated plant specialized in the production of suppositories licensed by the Bulgarian National Drug Agency and running under GMP requirements

The product portfolio includes suppositories from all pharmaceutical therapeutic groups for rectal and vaginal application.

Main manufacturing equipment includes:

• Homogenizer Fryma VME-400
• Vessel 120 l
• Filling and packaging line Sarong SAAS 15/AP

Manufacturing of syrups

Our range of services includes offering of  syrups contract manufacturing.

We are offering to our customers manufacturing of syrups. Sopharma has a dedicated syrup manufacturing line with state-of-the-art production equipment. Syrups are manufactured in compliance with GMP standards and meet the highest possible product quality requirements.

Sopharma offers manufacturing of syrups in a variety of final packages, including PET and glass bottles.

Main manufacturing equipment includes:

• Vessel Steridose 2 800 l
• Vessel Rotamil 1 000 l
• Homogenizer  ROMACO FrymaKoruma  with capacity 100 l /min suspension
• Primary packaging line Marchesini ML 661
• Secondary packaging line Marchesini MA100

Manufacturing of creams

One of the Sopharma’s contract manufacturing services is manufacturing of creams. We are a company specialized in manufacturing and packaging of different kind of creams. The plant capable to manufacture creams is GMP-approved and is able to produce a variety of packages including AL and laminated tubes.

Main manufacturing equipment includes:

• Vessels ZOATEC 200 l, 500 l and 700 l
• Homogenizer up to 700l
• Filling and packaging line NORDENPAC for Al and laminate tubes with filling head for 5÷150 ml and tube’s holders with diameter 20 mm

Manufacturing of ointments

Sopharma offers a wide range of services and innovative solutions to meet your contract manufacturing needs. Our GMP-approved plants are capable to offer manufacturing of ointments. As a contract manufacturer in the field of pharmaceuticals we serve our customers with high quality ointment and low production cost.

Main manufacturing equipment includes:

• Vessels ZOATEC 200 l, 500 l and 700 l
• Homogenizer up to 700l
• Filling and packaging line NORDENPAC for Al and laminate tubes with filling head for 5÷150 ml and tube’s holders with diameter 20 mm

Manufacturing of gels

Sopharma is your key partner if you are interested contract manufacturing of gels. We create the conditions to meet the specific customer requirements in manufacturing of gels at reasonable prices in full compliance with good manufacturing practice (GMP).

Main manufacturing equipment includes:

• Vessels ZOATEC 200 l, 500 l and 700 l
• Homogenizer up to 700l
• Filling and packaging line NORDENPAC for Al and laminate tubes with filling head for 5÷150 ml and tube’s holders with diameter 20 mm

EU GMP – certified manufacturing sites

The best contract manufacturers are those that believe in flexibility and quality. All of our facilities are certified, and all of our employees are professionalists and highly trained staff.

Our pharmaceutical health manufacturing services are carried out in fully licensed facilities and our capabilities meet the exacting requirements of our customers.

We are a holder of EU GMP - certified manufacturing sites for different dosage forms with the assurance for high product quality. Sopharma offers EU-GMP compliant pharmaceutical contract manufacturing.

All our plants are EU GMP-certified and they are able to produce different types of packaging based on customer demands (packaging in bags, packaging in containers, packaging in AL/ PVC, AL/ PVDC, ALU/ALU blisters,  packaging in carton boxes, packaging in bottles, packaging in tubes, shippers packaging).