These activities include manufacturing of veterinary products, infusion solutions, manufacturing of plastic disposable materials mainly for the hospital market, handling of dangerous wastes, gamma sterilization, manufacturing of dressing materilas etc.
These activities are carried out mainly by subsidiaries of Sopharma AD in Bulgaria.
Some of the specific products available as a result of these activities are:
- Veterinary vaccines
- Infusion solutions as glucose, natrii chloridum etc.
- Syringes, disposable clothing, catheters etc.
- Bandages, cotton products, surgical sutures etc.
The production and distribution of these products are mainly carried out by Medica AD, Momina Krepost, and Biopharm Engineering AD.
The beginning of Medica AD was set in 1971 when in the town of Sandanski was opened the Plant for production of bandages. Since then the company is an integral part of the Bulgarian pharmaceutical industry as it goes through various stages, related to the restructuring of production, renovation and modernization of the production facilities. The headquarters and management of Medica are located in Sofia and manufacturing and logistic facilities are located in Sandanski.
Medica AD is a Bulgarian manufacturer of high quality medical supplies and generic pharmaceutical products, with over 40 years of history.
Medica AD is a leader in the hospital and pharmacy market for medical supplies in Bulgaria.
The company’s many years of experience in the production of high quality medical supplies led to the establishment of the brands of the company, making them synonymous names for certain groups of products on the Bulgarian market.
Such brands are:
- Sanplast® and
Products are divided into several groups:
• cotton products
• elastic products
• products for first aid and sterile dressings
The largest share in sales have
• compresses, followed by
• patches and
• Psodermol lotion - cosmetic tool for intensive care for dry, itchy and scaly skin
• Algopix series – dermatological cosmetics for head and body containing four products
• Capsiplast Classic – a product suitable for cramps and stiffness, with a warming effect and aiding local circulation
Main foreign markets for Medica are Ukraine, Moldova, Russia, Macedonia and others, which comprise 26% of the company’s revenues.
Medica production capacity
The manufacturing facilities of Medica AD meet all European standards of production and meet the requirements of good manufacturing practice (GMP). The company is ISO-certified and has implemented a system of quality management and employs 230 highly qualified employees.
Medica has three separate facilities:
• Euromed – manufacture of sterile and non-sterile medical devices
• Pharmamedica – manufacture of non-sterile medicinal products – capsules and tablets
• Pharma – 2 - manufacture of non-sterile medicinal products – liquids for external use; therapeutic shampoos and medicines particularly intended for the treatment of wounds and specific skin problems.
All products of Medica are manufactured and stored under specific conditions (temperature, humidity, overpressure, etc.) in accordance with GMP and ISO standards.
• Solid dosage forms: 300-400 million units/ year
• Liquid forms: 2,5- 3,5 million units/ year
• Gauze compresses: 55 – 80 million units/ year
• Sterile compresses: 12- 16 million units/ year
• Steam sterilization for medical devices: over 2000 m3/year
• Knitted bandages: 1,2 – 2,4 million meters/year
• Elastic articles: over 130 000 units/year
Two separate warehouses dedicated to the different products:
• For medicinal products 1800 m2– with 3 separate areas – raw materials, packaging materials and finished product
• For medical devices - 3000 m2 – raw materials, packaging materials and finished product
Laboratory block consists of:
• Chemical laboratory
• Microbiological laboratory
• Premises for input and out control
All premises are built as to ensure sequence of technological processes, to avoid any cross contamination, to secure the required microclimate in the different zones, to guarantee hygiene and safety working conditions.
Water and air pollution are avoided.
Ecological measures incl. waste management and disposal are applied.
The manufacture of medicinal products and packaging of medical devices, which are subject to sterilization (in-house or not) are done in "clean" rooms, cleanness class ISO 8 provided with overpressure.
• The access to working, control and storage premises is limited
• Hygiene programs are developed,observed and controled ;
• Regular microbiological monitoring of air, surfaces and personnel in the manufacturing and control premises is carried out;
• The production systems and equipment are qualified;
• All critical manufacturing process are subject to periodical validation;
• All systems and all processes have on-line monitoring and records
Momina Krepost AD
The company was established in 1966. In the first years of its existence the company produced small rubber and plastic products. Since then the company has continuously expanded its product portfolio by introducing manufacturing facilities for the following products:
- injection and blast products for households and the industry;
- plastic medical disposable products for the human and veterinary medicine;
- blood transfusion systems and catheter “Butterfly”.
The production of plastic syringes began in 1984 after a license from the German company “MANNESMAN – DEMAG” was implemented. In 2005 the production line was again upgraded by importing high-performance equipment for the production of syringes Republic of Korea.
The company’s main activities are development, implementation and production of medicinal products for the human and veterinary medicine.
The company operates primarily on the Bulgarian market and exports roughly 15% of its products.
MEDICAL DEVICES FOR SINGLE USE
Manufacture of medical devices in Momina krepost PLC is carried out in the terms and conditions set forth in the requirements of Good Manufacturing Practice / GMP /. The company operates a certified quality management system based on ISO 9001:2008; ISO 13485 and Directive 93/42 / EEC and Directive 2007/47 / EO on the safety of medical devices. The characteristic of the technological processes is determined by the type of manufactured medical devices groups.
SYRINGES AND HYPODERMIC NEEDLES FOR SINGLE USE
The main materials for the production of syringes are polypropylene, high density polyethylene and a thermoplastic elastomer, which are physiologically harmless. For the packaging is used special paper for sterilization with ethylene oxide and combined film polyamide - polyethylene.
The hypodermic needles are imported in bulk. Packaging and sterilization only of needles or syringes with needles is done by Momina krepost PLC.
The manufacture of syringes is carried out on two technological lines - imported from Germany and Korea.
The equipment consisting of injection molding machines with computer control, printing and assembling and packaging machines has a high degree of mechanization and automation. The details of syringes are produced by the method of injection molding on injection molding machines, then submit to printing and assembling machines to print the scale and assembly of the syringes. Finished products are packaged on packaging machines for blister packaging.
The capacity of the production equipment is 100 million pieces syringes annually with a capacity of 1 ml, 2 ml, 5 ml, 10 ml, 20 ml and 50 ml, with and without needles, only needles – 20 million pieces.
PRODUCTS MADE OF POLYVINYL CHLORIDE
These are different types of infusion and transfusion sets, tubes, catheters, drainages, urine bags, nasal oxygen catheters, oxygen masks and others.
The main material for the production of these products is soft polyvinyl chloride granulate produced in Momina krepost PLC from suspension polyvinyl chloride and additives according to working formulations. For the production of the parts are used also polyethylene low and high density, polyamide, polystyrene with appropriate paramenters to ensure physiological safety of the devices. For packaging is used combined film polyamide - polyethylene or polyethylene and sterilization paper.
The equipment consists of a hot and cold mixer, granulator, extruders, injection moulding machines, assembly equipment, packaging machines and sterilization system.
The technological process includes: production of PVC granule, extrusion, injection moulding, sealing, control, assembly, packaging and sterilization of finished products. Production capacity of the equipment: Sets - 800 000 pieces; tubes, catheters, drainages and others - 800 000 pieces, Urine bags - 600 000 pieces.
PRODUCTS OF NONWOVEN FABRIC
This group includes: surgical clothing, masks, caps, etc., clothing for visitors; drapes and bed linen. The products are available sterile and non-sterile.
Materials - used is textile material based on polypropylene, comprising a non-woven layers which are thermally calendered. The material is hydrophilic or hydrophobic according to the intended purpose.
Equipment - Line for folding and cutting, sewing machines, overlocks.
Workflow - Operations: folding and cutting, sewing, folding, packaging and sterilization.
Production capacity: 1 300 000 pieces.
Sterilization of medical devices is done with ethylene oxide in sterilization installation, delivered by a French company in accordance with EN ISO 11135. The installation is validated and ensure successful sterilization process through controls and regulators of the process. During the sterilization is monitored every change of the controlled parameters and their values are recorded by the recorder on a PC. The sterility of each batch of finished products is determined by biological control.
The manufacture of the medical devices is waste-free. The materials are recovered and used for products not intended for medical purposes. Production area: approx. 4000 m2
GOODS FOR HOUSEHOLD AND INDUSTRY
Materials: High density polyethylene; low density polyethylene; polypropylene; ABS; polyamide; soft PVC compounds.
- Blow moulding automatic machines / for products of 3 L to 170 L / - Battenfeld, Kautex, BA - 60; VOITH - 8
- Injection moulding automatic machines / for products of 100 g to 2000 g / - Kuasy, TOS – RAKOVNIK, Formoplast FO
- Extruders – ШП – 63, ШП – 90.
- Blow moulding
- Injection moulding
- Drums / 8 litre, 25 litre, 35 litre, 50 litre, 65 litre, 120 litre, 170 litre / – 400 000 pieces
- Cans / 3 litre, 5 litre, 10 litre, 20 litre / – 800 000 pieces
- Injection moulded articles for household and industry/ fruit grate, cheese box, mail box, road cones etc. /– 400 000 pieces
Production area: approx. 13000 m2
Storage area of the company: approx. 2000 m2
Biopharm Engineering AD
Biopharm Engineering AD is a rapidly growing company. It has modern production units and constantly expand and modernize production facilities. The strategy of Biopharm Engineering AD is built on the market and technological advantages of the company. The company holds a certificate of good manufacturing practice (GMP). The company develops successfully in the following areas:
- production of infusion solutions;
- production of injection solutions;
- production of veterinary medicinal products and immunological preparations
The large potential of the production base and the modern technologies allow Biopharm Engineering AD to accept contracts from Bulgarian and international companies to manufacture their products in polypropylene bottles, sacks and ampoules.
The history of Biopharm Engineering AD dates back to 1981 when the FAO-UNDP project BUL 77/11 was implemented and an institute for fighting the foot-and-mouth disease and very dangerous infections was established. In 1998, the institute was privatized by Biopharm Engineering, specially established for this purpose. In 2006, shares in the capital of the company were acquired by Sopharma AD. Over the years, Biopharm Engineering has continued to expand and modernize its production capacities
- infusion and injection solutions;
- veterinary medicinal products – vaccines and diagnostic kits.
The manufactured infusion solutions are marketed through the parent company Sopharma AD both on the Bulgarian and the international market.
Main financial indicators
|BGN '000||BGN '000||%|
|Earnings before interest, taxes, depreciation and amortization (EBITDA)||-589||2,220||-126.5%|
|BGN '000||BGN '000||%|
|EBITDA / Sales revenue||(8.4%)||27.7%|
|Operating profit/ Sales revenue||(5.30%)||30.90%|
|Net profit/ Sales revenue||(7.70%)||29.90%|
|Borrowed capital/ Equity||0.15||0.08|
|Net debt/ EBITDA, annualized||(3.1)||0.4|