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Human & Veterinary Pharmaceuticals
Human & Veterinary
Pharmaceuticals
www.huvepha rma . com
3www.huvepharma.com
DEAR PARTNER,
As the President of Huvepharma®, I would like to take a few minutes of your time to communicate to you our vision for growth and the benefits we can offer to you as a partner.
Huvepharma® is a fast-growing organization that expanded as a result of vigorous internal growth coupled with several acquisitions over the past few years. We believe we will continue to grow because we offer unmatched benefits to our customers and partners. The Huvepharma® group of companies encompasses manufacturing facilities and sales and marketing organizations around the globe that establish direct relationships with every customer. Huvepharma® employs highly qualified and experienced specialists in its R&D, production, regulatory affairs, sales, and marketing structures. The highly efficient integrated structure and the excellent human capital allow our company to offer competitive and beneficial conditions.
The fact that a big part of our manufacturing facilities are located in Bulgaria gives us access to a highly-qualified labor force and competitive costs of utilities (electricity, steam, water, waste-water treatment). These advantages allow us to be more flexible in meeting customers’ and partners’ needs. Our state-of-the-art production and quality control equipment ensure we manufacture a quality product.
The significant investments that have been accomplished over the past few years have enabled our company to be more responsive to market changes, to develop multipurpose production, to be more efficient, more competitive and to offer an enlarged product portfolio with registrations in more than 70 countries that we will continue to expand in the future.
Our experience and management team is developing Huvepharma® into a high-growth international player by integrating acquired companies and seeking to obtain new product registrations in key markets worldwide.We welcome new proposals for partnerships for development of new products and technologies.
Huvepharma® is committed to take up a leading role as a global marketing and manufacturing company of human health products, animal health products and enzymes to serve the needs of our existing customers, as well as expand our capabilities to attract and retain new customers and partners.
With respect,Kiril DomuschievPresident, Huvepharma®
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Corporate Vision for Growth
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Huvepharma® is a fast-growing global pharmaceutical company with a focus on developing, manufacturing and marketing human nutraceutical and animal health products. These pillars are the basis of our company name, Huvepharma®: HUman and VEterinary PHARMAceuticals. We place equal emphasis on the creation and marketing of products for animals and for humans. The company also manufactures and markets enzymes for food, feed and industrial applications.
Huvepharma® is a privately-owned company, headquartered in Sofia, Bulgaria.
IntroducingHuvepharma®
Intr
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Huv
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rma®
5www.huvepharma.com
Huvepharma’s manufacturing subsidiary, Biovet, is headquartered in Peshtera, Bulgaria, and it has independent manufacturing units at different locations. Its modern fermentation plants provide a high capacity for production of major molecules including purification and downstream processing. The production subsidiary also has extensive R&D, quality assurance and packaged goods facilities.
Our expertise lies in the creation of a close partnership with the customer and in the emphasis we place on best addressing a customer’s total requirements for pharmaceuticals and feed additives. In each of our locations, Huvepharma® employs highly skilled individuals with extensive experience in the animal health industry and with knowledge of their local markets and customers.
Huvepharma® has offices and subsidiaries in USA, Bulgaria, Belgium, Poland, China, Taiwan, Thailand, India, Russia and Brazil. Huvepharma® and its representatives worldwide are responsible for marketing of a wide range of products. This sales and marketing network allows Huvepharma® to distribute its products and services to customers worldwide.
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Brazil
USA
Belgium
World Presence
In Huvepharma® NV, located in Antwerp, Belgium, the global sales and marketing functions are centralized. Huvepharma® NV also provides direct support to all customers in the EU.
Huvepharma®, Inc. is located in the USA near Atlanta, GA. The company markets our products with dedicated sales and technical experts for different species. It also spearheads development plans for registering new products on that market.
Huvepharma® Polska is the company’s subsidiary in Poland and it distributes Huvepharma’s products in Poland and the Baltic states.
St. Louis pharmaceutical plant – Manufacturing of animal health products
Huvepharma’s subsidiary in Brazil is responsible for sales and marketing for the local market.
www.huvepharma.com7
PolandRussia
Taiwan
ThailandIndia
Bulgaria
China
Huvepharma’s headoffice is based in Sofia, Bulgaria and is responsible for international sales and marketing activities worldwide. It also coordinates the relations with our suppliers within and outside the Huvepharma group.There are three manufacturing facilities in Bulgaria – Botevgrad – for production of enzymes and probiotics, Razgrad – for production of human API’s, nutraceutical and veterinary products and Peshtera – for production of veterinary products, technical grade products, API’s and finished forms.
Huvepharma® has a representative office in Moscow, Russia. Besides its regulatory function, it is responsible for distributing and marketing our products in Russia.
Huvepharma’s subsidiary in India is responsible for sales and technical assistance for the local market, Bangladesh, Sri lanka and Nepal.
Huvepharma® has representative offices in Beijing, China and trading companies in Taipei, Taiwan and Bangkok, Thailand where dedicated sales and technical teams serve the local markets.
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2002
2000
1993-1999
1980-1986
1954-1975
Com
pany
Ori
gin Huvepharma® is built on the strong foundations and
longstanding reputation of the businesses that make up our group.
The company is now realizing the synergies between its management and marketing know-how and development strategy and the more than half a century expertise and tradition in human and animal health products and enzymes manufacturing of each of the companies it acquired over the past few years: Biovet, Zelin, Balkanpharma (Actavis) – Razgrad, Intervet’s Feed Additives business and Merial Feed Additive products.
As a result of internal developments and external acquisitions, Huvepharma® has transformed into a global pharmaceutical production and marketing company.
CompanyOrigin
9www.huvepharma.com
Mile
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f O
ur
Com
pany
His
tory
2009
2007
2006
2005
2002
2000
1993-1999
1980-1986
1954-1975
• Tylosin production line in the Razgrad plant is approved by FDA• Injectables and tableting lines are completed in Peshtera plant• Biovet ISO 9001 is certified• GMP systems are certified
• Huvepharma® opens a subsidiary company in India
• Huvepharma® acquires the anticoccidial range of Merial Inc and the production site of Saint Louis, USA
• Huvepharma® opens a representative office in Russia• Huvepharma® establishes a subsidiary company in Thailand
• Production companies are established in Peshtera, Botevgrad and Razgrad, Bulgaria
• R&D departments are created in each of the manufacturing companies
• Downstream processing facilities are constructed in Peshtera and Razgrad
• Wastewater treatment plants are built in Peshtera and Razgrad
• Huvepharma® receives a FDA approval and an EU GMP certificate• A subsidiary company is established in Taiwan • Huvepharma® sets up a representative office in China
• Company’s name is officially changed from Biovet into a global brand, Huvepharma®. (Human and Veterinary pharma)
• Huvepharma® receives feed additives GMP and HACCP certification by SGS (Ovocom).
• The company acquires Balkanpharma Razgrad, part of Actavis• Acquisition of Intervet’s feed additives global business is made • Huvepharma® sets up subsidiary companies in Belgium and
the USA
• Biovet acquires Zelin (Botevgrad), an enzyme manufacturing plant
• In this year the acquisition of the Peshtera plant is realized
Milestones of Our Company History
2010
2012
• A subsidiary company is established in Brazil
• Huvepharma® AD through its subsidiary Biovet® opens a new plant for production of biotechnological and pharmaceutical products in the town of Razgrad, Bulgaria.
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Man
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Huvepharma group of companies has 3 manufacturing sites in Europe and one blending unit in the US. Its total fermentation capacity is more than 6000m3. Huvepharma® also has its own chemical synthesis plants for production of APIs, downstream facilities for processing and granulation, formulation and packaging of technical grade products, feed additives and finished pharmaceutical goods. Next to these production facilities Huvepharma® has warehouses for incoming materials and finished goods, quality control and quality assurance laboratories, and R&D laboratories for product development. To ensure the needs of the manufacturing processes, there are utilities plants for electricity, compressed air steam and natural gas distribution on site service units, and wastewater treatment plants.
There are three production sites in Bulgaria. One is in Botevgrad – for manufacture of enzymes and probiotics, one in Peshtera and one in Razgrad – both for manufacture of technical grade products, API’s, veterinary products and finished dosage forms.
In June, 2012 a new production unit in Razgrad was put into operation, which increases with 20% the total fermentation capacity of Huvepharma®. This state-of-the art production facility fully complies with the best practice and knowledge in pharmaceutical and biotech industry. Latest generation automated and high technology equipment is installed in this plant, providing production of different biotech products, according to the latest GMP and FDA standards.
In addition, Huvepharma® has a modern pharmaceutical plant for the production and blending of animal health products, located in the USA – St. Louis, Missouri.
ManufacturingFacilities
11www.huvepharma.com
Huvepharma’s key strength lies in fermentation. The company’s manufacturing subsidiaries have been developing this expertise for more than half a century.
At Huvepharma®, operations and activities throughout the production process are automated using the latest generation equipment and digital technology for interfacing with peripheral devices.
Huvepharma’s manufacturing plants have several chemical purification and isolation facilities for production of active pharmaceutical ingredients complying with international pharmacopoeia standards.
Huvepharma® has made significant investments in innovations and technology know-how for the construction of a new formulation and granulation plants in an effort to meet customer requirements for dust-free and free-flowing product. Huvepharma® is a reliable supplier of human and veterinary API’s for leading players in the international markets. As partnership is one of our key objectives, we take our time to evaluate our customers’ needs and to offer them the best quality products.
The GMP and FDA-approved packaged pharmaceuticals plant manufactures products that are exported to the EU, USA, Central and Eastern Europe, CIS, the Middle East, Asia and Latin America.
All manufacturing complexes have modern warehousing facilities that meet all necessary requirements to ensure safe storage.
ProductionProcesses
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Emph
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Qua
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Huvepharma® and its production subsidiary Biovet are certified by SGS for GMP + HACCP Animal Feed Sector (OVOCOM). Our products are part of the food chain and we are committed to following GMP and HACCP principles to ensure that we deliver a safe product to the consumer.
Huvepharma’s subsidiary, Biovet, implemented an integrated management system for quality management and environmental protection ISO 9001:2008/ ISO 14001:2004 certified by SGS. Biovet has been ISO 9001 certified since 1999. It received EU GMP certificate for its sterile injectables, powder and medication premix production facilities, which also have passed successfully FDA inspections.
Huvepharma® emphasizes quality assurance throughout the entire cycle of production, distribution and use. The Quality Control Departments execute strict quality control of all incoming materials, critical parameters during manufacture, intermediate and finished products in accordance with the approved specifications. Production steps and processes are carried out by following detailed standard operating procedures and work manuals and detailed written records are created and kept for each production batch. The management oversees an ongoing training program for improvement of the qualifications of both employees and management.
Huvepharma’s enzymes plant in Botevgrad produces enzymes for food and feed applications. The plant received an Excellent mark in Food Safety in its certification by the American Institute of Baking. As a part of the certification process, the company developed and implemented HACCP (Hazard Analysis and Critical Control Point) principles in its enzymes manufacture.
Emphasis on Quality
13www.huvepharma.com
Huv
epha
rma®
G
loba
llyHuvepharma® is active on every continent with the same dedication to provide high quality products for human and veterinary use.
Huvepharma® is present in every major market and holds important product registrations in the USA (FDA approved) and in the European Union (BSA). We also partner with all major export-oriented integrators in Latin America and Asia that value products with a Brand Specific Approval (BSA) in the EU.
Huvepharma® continually searches for improvement of its animal health products in its R&D facilities as well as in collaboration with universities to respond to the specific needs of each market.
We place special emphasis on the emerging markets where intensive livestock is under full development. Therefore, we have set up own subsidiaries in Brazil, Taiwan, Thailand and India, and representative offices in Russia and China.
In Latin America, we are solidifying our presence in the region after several years of development of our key antibacterial and anticoccidial feed additives in Brazil and Mexico, where our products are best established. Our growth in the region will come from the balanced and focused portfolio we offer in the area, particularly Coxidin®, Sacox®, Salocin®, and Flavomycin®. We also drive to develop our positions in the remaining Latin American countries.
In Canada, Huvepharma® markets a broad range of anticoccidials, veterinary products and performance enhancers, including some licensed products specifically for this market.
Huvepharma® acquisition policy takes every opportunity seriously, examines the possibilities to enlarge its human and veterinary portfolio and to support these new products in their strong sales growth for both – human and veterinary pharmaceutical markets.
Huvepharma® Globally
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Inve
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Env
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men
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Fr
iend
ly T
echn
olog
ies Huvepharma’s manufacturing subsidiaries have developed an
environmental management system certified in compliance with the requirements of the international standard ISO 14001:2004.
Huvepharma® has built co-generation plants to ensure the supply of energy, steam and purified water for its production. The investment in own co-generation plants gives Huvepharma® a cost advantage and in the future ensures stability and competitiveness in the cost of production. The company has built a co-generation facility in Biovet, Peshtera and it is currently constructing another plant in Razgrad, Bulgaria. These facilities help for environmental protection because the new power plant will generate reduction of CO
2 emissions.
Huvepharma® trades these emmissions according to the Kyoto Protocol in the European Union.
Huvepharma® has modernized waste water treatment plant.
The company looks for novel ways to reduce production waste and recycle materials. It produces different types of organic fertilizers from substrate by-products from the manufacturing process. The novel fertilizer significantly improves the qualities of agricultural soil and Huvepharma® plans to also export this fertilizer in European Union countries.
As another way of protecting the environment, in 2005, Huvepharma® received a complex license No 28/2005 for industrial installations under the Integrated Pollution Prevention Control (IPPC) Directive of 1996 by the Ministry of the Environment and Waters. This program puts us in the lead among Bulgarian companies in the implementation of European Union environmental protection requirements. This permit encompasses the entire production process and sets the guidelines and procedures for operating in an environmentally-friendly way.
Investing in Environmentally Friendly Technologies
15www.huvepharma.com
Huvepharma® markets an extensive range of anticoccidials, antibacterials, performance enhancers, enzymes and antiparasitics for animal health and nutrition.
Amprol® (amprolium)
Coyden® (clopidol)
Sacox® (salinomycin)
Coxidin®(monensin)
Stenorol®(halofuginon)
Flavomycin®(flavophospholipol)
Pharmasin® (tylosin)
Vetmulin® (tiamulin)
Tilmovet® (tilmicosin)
HydroDoxx® (doxycycline)
Hostazym® X (NSP enzymes)
Hostazym® suis (multi-enzymes)
Hostazym® P (phytase)
(phytase)
GAINPRO®(flavophospholipol)
Our
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Our Brands
Lianol®
w w w . h u v e p h a r m a . c o m
Huvepharma® Polska • ul. Smocza 27 • 01-048 Warszawa
Poland • P +48 22 831 1080 • F +48 22 831 0534
[email protected] • www.huvepharma.pl
Huvepharma® (Thailand) Ltd. • 23rd Floor, Elephant Tower, Zone B
3300/118 Phaholyothin Road, Jompon • Chatujak, Bangkok 10900
Thailand • P +(66 2) 937 4355 • F +(66 2) 937 4351
Huvepharma® Russia – Representative office
19 Roschinskiy proezd 4th, office 104 • Moscow 115191
Russia • P +7(495) 958 5656 • F +7(495) 958 5666
Huvepharma® India • Flat No. 104, First Floor, Green Terrace, Lane No. 5,
South Koregaon Park, Kawdewadi • Pune - 411 001
India • Telefax +91 20 2605 3973
Huvepharma® do Brasil Comércio e Importação Ltda
Avenida Carlos Gomes, 1200 - Conj. 602 • ZIP 90480-001 • Porto Alegre, RS
Brazil • P +55 51 3085 3564 • F +55 51 3085 3564
Huvepharma® AD • 3a Nikolay Haytov Str. • 1113 Sofia
Bulgaria • P +359 2 862 5331 • F +359 2 862 [email protected]
Huvepharma® N.V. • Uitbreidingstraat 80 • 2600 Antwerp
Belgium • P +32 3 288 1849 • F +32 3 289 7845
Huvepharma® Inc. • 525 Westpark Drive, Suite 230
Peachtree City, GA 30269
USA • P +1 770 486 7212 • F +1 770 486 7217
Huvepharma® Taiwan • 12F.-1, No.190, Sec. 2, Zhongxing
Rd., Xindian Dist., New Taipei City
Taiwan( R.O.C) • Zip code: 23146
Tel: +886 2 2918 5819 • Fax:+ 886 2 2918 5009
Huvepharma® Beijing – Representative office
Room B11-D2, Ke-Shi Plaza, No 28, Shangdi-Xinxi Rd
Haidian District, Beijing 100085
China • P +86 10 6212 9530 • F +86 10 6214 5438
CorBrV3-0113
