Sopharma Group is an integrated business focused in the health care sector including three main business line:
- Manufacturing of pharmaceutical products
- Non-pharma activities
- Distribution of health related products
The pharmaceutical manufacturing is carried out at the mother company Sopharma AD and by the following subsidiaries:
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 Law of Public Offering of Securities.
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
Sopharma AD has twelf 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 200 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;
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 four 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.
The average number of employees of Sopharma AD as at June 30, 2020 is 2 195 (30.06.2019 - 2275).
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.
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.