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Manufacturing of pharmaceutical products

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Sopharma Group is an integrated business focused in the health care sector including three main business line:

The pharmaceutical manufacturing is carried out at the mother company Sopharma AD and by the following subsidiaries:

Sopharma AD

General information

Sopharma AD was established in 1933. The court registration of the Company is from 15.11.1991 and it is a public company under the Public Offering of Securities Act.

The Company conducts the production and marketing of medicinal substances and dosage forms; research, engineering and implementation activities in the field of phytochemistry, chemistry and pharmacy. Sopharma AD provides services related to production, as well as to ancillary and service activities.

The Company has marketing authorizations under the Law on Medicines and Pharmacies in

Industrial activity

Sopharma AD has ten manufacturing facilities, which are compliant with EU regulations and are located in Bulgaria. The Company is the largest Bulgarian producer of ampoules and suppositories.

The Company carries out and develops production in the following areas:

  • Substances and preparations based on vegetable raw materials (phytochemical production);
  • Finished dosage forms including
    • Solid tablets, coated tablets, coated tablets, capsules;
    • Galenical - suppositories, drops, syrups, unguents;
    • Parenteral - injectables, powders for injections lyophilic

The Company has more than 210 products in its portfolio: mainly generics and 15 original products, 12 products are phyto-based. The original products of the Company (and in particular Carsil and Tempalgin) are key contributors to its revenues from export markets, while for the domestic sales the most important products are generics, among which the leading medicine is Analgin.

The product portfolio of Sopharma AD is focused on the following therapeutic areas: cardiology, gastroenterology, pain management, cough and cold, immunology and dermatology, respiratory and asthma, neurology and psychiatry, urology and gynecology.

The most important pharmaceutical products in terms of their contribution to revenues are:

  • Carsil - original product plant-based, used to treat gastroenterological disorders (liver disease);
  • Tempalgin - original analgesic (painkiller);
  • Tabex – original plant-based drug used for smoking secession
  • Tribestan – original plant-based product, used for stimulation of the reproductive system
  • Broncholytin - original plant-based product used to suppress cough;
  • Analgin - generic analgesic (painkiller);
  • Nivalin – original phyto-based product, used in the treatment of the peripheral nervous system;
  • Methylprednisolone - generic drugs for cases of severe allergies and certain life-threatening conditions;

Intellectual property

Although oriented towards generic pharmaceuticals, Sopharma AD is known for many years with its traditional production of several unique products based on plant extracts obtained by in-house-developed extraction technologies. In addition to trademark these products are protected with patent or corporate know-how.

For the distinguishing of the manufactured generic products Sopharma AD relies on brand names, all of which are registered trademarks of the Company. In all the years of its existence, Sopharma AD generates and protects its intellectual property. As a result, the Company owns a large number of intellectual property assets, the majority being registered rights (trademarks, patents, designs) and few of which are unregistered items - mainly technologies.

These assets are the result of the policy of the Company towards product and technological improvement, and innovation in particular.

Research and development

Sopharma AD focuses its R&D mainly on generics. The R&D projects are focused on finding and developing new formulas and compositions or physical properties (such as formulation or tablets) of the products in order to adapt them to current market needs. Strategic goal of Sopharma AD in the future is to achieve a stable result in developing eight to ten new products annually.

The Company mainly submits applications for marketing authorizations of new products, including new forms of products in Bulgaria and / or export markets and for existing products in new markets.

Employees

The average number of employees of Sopharma AD is around 1900.

Main financial indicators

Indicators01/06/201601/06/2015change
 BGN '000BGN '000%
Sales revenues 78,930 87,999 -10.30%
EBITDA 21,318 21,354 -0.20%
Operating profit 14,310 13,815 3.60%
Net profit 33,758 25,883 30.40%
CAPEX 5,141 7,846 -34.50%

 Indicators30.06.201631.12.2015 change
 BGN '000BGN '000
Non-current assets 394,205 398,781 -1.10%
Current assets 187,546 171,828 9.10%
Owners' equity 456,343 431,626 5.70%
Non-current liabilities 41,426 44,316 -6.50%
Current liabilities 83,982 94,667 -11.30%

Unipharm AD

General information
Unipharm is an established manufacturer of medicinal products meeting the highest standards of Good Manufacturing Practice. The mission of Unipharm is the production of medicines with care for people. The core operations of Unipharm AD are production of pharmaceuticals, research and experimentation in the production of pharmaceuticals, establishing quality of manufactured medicines, wholesale trading activities at home and abroad. The company strives to meet the requirements of the market and concentrates on finding new market niches to meet the growing needs of consumers. The company invests in production and scientific implementation mainly in the field of generic products.


Products

Solid dosage forms
The tablet forms are used to treat diseases of the cardiovascular, gastrointestinal, neurologic and respiratory systems.

Concentrates for hemodialysis
The Company is the main manufacturer of solutions in Bulgaria. In 2013 Unipharm released new concentrates for hemodialysis. The new product list covers all groups concentrates for hemodialysis: acetate, a wide range of certified acid concentrated for bicarbonate hemodialysis with dilutions 1:35 and 1:45, an extended group of alkaline concentrated for bicarbonate hemodialysis with an innovative bicarbonate solution 8,4% Plus (to reduce cardiovascular and soft tissue calcification, and also a dry sodium bicarbonate in its two known forms – “cart” and “bag”.

Liquid dosage forms Unipharm AD is the only manufacturer of sopharma AD for the following medicinal products:

  • Oral drops:
    • Vitamin А – without prescription
    • Deavit - with prescription
    • Tilidin Sopharma – opioid analgesic with special prescription
    • Analgin – non-presription analgesic
  • Ear drops:
    • Furotalgin – for treatment of acute inflammatory conditions of the internal auditory canal and the middle ear.
  • Gels:
    • Feloran 1% and 5% without prescription

Unipharm produces also medical products of its own – medicines and healthcare products:

  • Nasal drops:
    • Xylopharm 0,05% (for children) and 0,1% (for adults) without prescription.
  • Dermal solutions:
    • Acnerin 3% with prescription
  • Healthcare products (diagnostic devices):
    • Ultrafonogel
    • Oftalmogel

Main markets
The company's products are sold mainly on the Bulgarian market, but also in countries such as Russia, Ukraine, Georgia and other CIS nations, Tunisia, Lithuania, Latvia, Poland and others.

Main financial indicators

Indicators20152014change
 BGN '000BGN '000%
Sales revenue 19,672 19,359 1.7
Operating profit 1,270 2,053 (38.14)
Net profit 1,138 1,809 (58.9)
Indicators31.12.201531.12.2014 Change
BGN '000BGN '000 %
Non-current assets 11,799 12,647 -6.71%
Current assets 8,738 8,672 0.76%
Equity 17,726 18,037 -1.72%
Non-current liabilities 1,283 1,653 -22.38%
Current liabilities 1,528 1,629 -6.20%

Ratios20152014
Operating profit/Sales revenue 6.5% 10.6%
Net profit/Sales revenue 5.8% 9.3%
Borrowed capital/Equity 0.16 0.18

Biopharm Engineering AD

General information
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.

History
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

Products

  • infusion and injection solutions;
  • veterinary medicinal products – vaccines and diagnostic kits.

Main markets
The manufactured infusion solutions are marketed through the parent company Sopharma AD both on the Bulgarian and the international market.

Main financial indicators

Indicators20152014change
 BGN '000BGN '000%
Sales revenue 7,050 8,012 -12.0%
Earnings before interest, taxes, depreciation and amortization (EBITDA) -589 2,220 -126.5%
Operating profit -374 2,472 -115.10%
Net profit -540 2,393 -122.6%
Indicators31.12.201531.12.2014change
 BGN '000BGN '000%
Non-current assets 13,978 11,871 17.7%
Current assets 3,954 10,701 -63.1%
Equity 10,254 10,801 -5.1%
Non-current liabilities 3,557 6,314 -43.70%
Current liabilities 4,121 5,457 -24.50%

Ratios20152014
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

PAT Vitaminy

History
The factory was founded in February 1953 as one of the first in the Soviet Union companies manufacturing vitamins. The establishment of the company is linked to the development of new technologies for the country's industry: the production of nicotinic acid and nicotinamide, racemic menthol, DL-calcium pantothenate, D (+) calcium pantothenate. The team of the factory consisted of 67 people. In July, the 1952, the first production of vitamin "C" with glucose were released. The first year was marked by the release of 50 MT of pills, which were sent to Ukraine, the RSFSR, Georgia, Estonia, Uzbekistan. Production volumes rapidly increased and reached to 143 MT in 1954. In 1955 the factory team for the first time in the USSR started industrial production of nicotinic acid. By 1960 it had mastered the production of tablets of vitamin "C" with glucose, nicotinic acid, vitamin "C" for food additive. Part of this production was exported to the German Democratic Republic, Hungary, Vietnam.

The product range was constantly expanding and in 1963 the plant produced liquid menthol, and by 1965 its volume increased by 6 times.

The first batch of the calcium pantothenate was produced in 1964. By 1968, working at full capacity the plant produced: nicotinic acid and nikotinomida, calcium pantothenate, menthol etc. In 1994, in accordance with the Decree of the President of Ukraine the factoy was established as a JSC Vitamini.

In 2011, the company changed its form of ownership, becoming a public company. In 2012 it obtained a license to manufacture medicines according to the Ukrainian regulations.

PJSC "Vitamini" is producing and selling medicines in the form - tablets, powders, oily solutions, syrups and tinctures. Drugs production of PJSC "Vitamini" is highly efficient, with excellent quality, accessibility successfully sold not only in Ukraine and CIS countries.

Currently, the production is carried out in the following production sites:

  • liquid dosage forms;
  • two production sites for solid dosage forms;
  • extracts production site;
  • tinctures production site;
  • solutions production site;
  • powder production site.

Production sites are equipped with modern and high-performance equipment.

The company operates a system of quality assurance and multi-level quality control: our experts will check the quality of incoming raw materials, monitor the compliance with all standards and requirements for quality in the manufacturing process of drugs, monitor the quality of the finished product. Our attention to quality of the products is carried out throughout the entire product lifecycle - from design to receipt of its user.

Monitoring the quality of products - an essential quality management system process, which is implemented by studying the quality indicators of stability during shelf life, as well as due to the functioning of the pharmacovigilance system.

The quality control department carries out quality control of the production process. The laboratory is certified by the quality control directorate of the State Service of Ukraine on Medicinal Products and the Ukrainian State Research and Production Center of Standardization, Metrology and Certification. The structure of the quality control laboratory includes analytical laboratory and microbiological laboratory.

Products
http://www.vitaminy.com.ua/ru/preparations

 Main financial indicators

Indicators20152014
BGN '000BGN '000
Sales revenues 13,253 51,969
Operating profit -3,585 -5,147
Net profit -9,283 -13,407
Indicators31.12. 201531.12.2014
 BGN '000BGN '000
Non-current assets 4,750 6,343
Current assets 13,671 29,199
Owners' equity -15,517 -9,502
Non-current liabilities 20,376 501
Current liabilities 13,562 44,543

Ratios20152014
Operating profit/ Sales revenue -27,1% -9,9%
Net profit/ Sales revenue -70,0% -25,8%
Borrowed capital/ Equity -2.2 -4.7