Teva Active Pharmaceutical Ingredients (TAPI)
Encyclopedia
Teva Active Pharmaceutical Ingredients (TAPI) is an international pharmaceutical company
headquartered in Israel
. TAPI is a stand-alone business unit of Teva Pharmaceutical Industries limited
, the largest generic drug
manufacturer in the world and one of the 15 largest pharmaceutical companies worldwide.
On top of supplying a major share of Teva's own needs, the TAPI division is an active competitor in world markets, investing both in the development of new products and manufacturing processes and in the upgrading of production facilities. In 2009, TAPI's sales to third parties totaled $565 million, and in 2010 sales rose by 13% to a total of $641 million. This growth occurred in all of TAPI's principal geographical markets: North America
, Europe
and International. As of 2010, Teva Active Pharmaceutical Ingredients employs over 5,000 professionals world-Wide, and offers a rich portfolio of about 300 active pharmaceutical ingredients.
group at TAPI consists of a team of over 760 top scientists located in 7 development centers worldwide: A large center in Israel
(synthetic products and peptides
), a large center in Hungary
(fermentation
and semi-synthetic products), and a facility in India
and additional sites in Italy
, Croatia
, Mexico
and the Czech Republic
(development of high potency API).
TAPI's R&D focuses on the development of processes for the manufacturing of API, including intermediates, chemical and biological (fermentation), which are of interest to the generic drug industry, as well as Teva's proprietary drugs. The API R&D division also seeks methods to continuously reduce API production costs, enabling TAPI to improve its cost structure.
TAPI’s holds expertise in a variety of production technologies, including chemical synthesis
, semi-synthetic fermentation, enzymatic synthesis, high potent
manufacturing, plant extract
technology, synthetic peptides, vitamin D
derivatives and prostaglandins
. Also, its advanced technology and expertise in the field of solid state particle technology enables it to meet specifications for particle size distribution
(PSD), bulk density
, specific surface area, polymorphism
, as well as other characteristics.
Teva’s API facilities meet all applicable current Good Manufacturing Practices
(cGMP) requirements under U.S., European, Japanese, and other applicable quality standards. In some of the products that are sold in the U.S., TAPI utilizes controlled substances
and therefore must meet the requirements of the Controlled Substances Act
and the related regulations administered by the Drug Enforcement Administration
.
, cardiovascular, anti-cholesterol
, central nervous system
, dermatological
, hormones
, anti-inflammatory
, oncology
, immunosuppressants
and muscle relaxants
. Its API intellectual property
portfolio includes over 1,200 granted patents and pending applications worldwide.
Pharmaceutical company
The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
headquartered in Israel
Israel
The State of Israel is a parliamentary republic located in the Middle East, along the eastern shore of the Mediterranean Sea...
. TAPI is a stand-alone business unit of Teva Pharmaceutical Industries limited
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd. , is an international pharmaceutical company headquartered in Petah Tikva, Israel. It specializes in generic and proprietary pharmaceuticals and active pharmaceutical ingredients...
, the largest generic drug
Generic drug
A generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its...
manufacturer in the world and one of the 15 largest pharmaceutical companies worldwide.
On top of supplying a major share of Teva's own needs, the TAPI division is an active competitor in world markets, investing both in the development of new products and manufacturing processes and in the upgrading of production facilities. In 2009, TAPI's sales to third parties totaled $565 million, and in 2010 sales rose by 13% to a total of $641 million. This growth occurred in all of TAPI's principal geographical markets: North America
North America
North America is a continent wholly within the Northern Hemisphere and almost wholly within the Western Hemisphere. It is also considered a northern subcontinent of the Americas...
, Europe
Europe
Europe is, by convention, one of the world's seven continents. Comprising the westernmost peninsula of Eurasia, Europe is generally 'divided' from Asia to its east by the watershed divides of the Ural and Caucasus Mountains, the Ural River, the Caspian and Black Seas, and the waterways connecting...
and International. As of 2010, Teva Active Pharmaceutical Ingredients employs over 5,000 professionals world-Wide, and offers a rich portfolio of about 300 active pharmaceutical ingredients.
History
At the heart of the API division is the Israel-based Teva-Tech, formerly known as the Assia and Plantex plants which manufacture, develop and market raw materials for pharmaceuticals.Acquisitions
TAPI has grown by acquiring top rated manufacturing and development facilities around the world. Today, TAPI operates 21 plants worldwide. Major TAPI’s acquisitions:- 2011 - Teva Acquisition of Theramex in Monaco
- TAPI 2008 Acquisitions
- December 2008 – Teva Acquisition of BarrBarr PharmaceuticalsBarr Pharmaceuticals was a global specialty pharmaceutical company that operated in more than 30 countries worldwide. Barr were engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.-History:Barr...
-PlivaPlivaPliva d.d. is a Croatian pharmaceutical company, based in Zagreb, Croatia. One of the world's largest producers of generic Adderall, it has seen drastic increases in revenue with an increasing number of patients being diagnosed with Attention Deficit Disorder . It is the largest pharmaceutical...
in Croatia - July 2008 – Teva Acquisition of Bentley in Spain
- April 2008 – TAPI Acquisition of Archimica in Puerto Rico
- December 2008 – Teva Acquisition of Barr
- Acquisitions & Foundations since the 90's
- 2006 – Acquisition of Wanma in China
- 2005 – Acquisition of IVAX APIIvax CorporationIVAX Corporation was a Miami, Florida, United States public corporation focused on manufacturing and distributing generic pharmaceutical products.-History:...
in Czech Republic and Puerto Rico - 2004 – Acquisition of Sicor API in Italy, Mexico and Switzerland
- 2003 – Acquisition of RDL in India
- 2002 – Acquisition of PFC in Italy
- 1996 – Acquisition of BIOCRAFT in Missouri (US)
- 1995 – Foundation of TEVA-TECH in Israel
- 1995 – Acquisition of ICI in Italy & BIOGAL in Hungary
- 1991 – Acquisition of PROSINTEX in Italy
Research and Development
The R&DResearch and development
The phrase research and development , according to the Organization for Economic Co-operation and Development, refers to "creative work undertaken on a systematic basis in order to increase the stock of knowledge, including knowledge of man, culture and society, and the use of this stock of...
group at TAPI consists of a team of over 760 top scientists located in 7 development centers worldwide: A large center in Israel
Israel
The State of Israel is a parliamentary republic located in the Middle East, along the eastern shore of the Mediterranean Sea...
(synthetic products and peptides
Peptide
Peptides are short polymers of amino acid monomers linked by peptide bonds. They are distinguished from proteins on the basis of size, typically containing less than 50 monomer units. The shortest peptides are dipeptides, consisting of two amino acids joined by a single peptide bond...
), a large center in Hungary
Hungary
Hungary , officially the Republic of Hungary , is a landlocked country in Central Europe. It is situated in the Carpathian Basin and is bordered by Slovakia to the north, Ukraine and Romania to the east, Serbia and Croatia to the south, Slovenia to the southwest and Austria to the west. The...
(fermentation
Fermentation (biochemistry)
Fermentation is the process of extracting energy from the oxidation of organic compounds, such as carbohydrates, using an endogenous electron acceptor, which is usually an organic compound. In contrast, respiration is where electrons are donated to an exogenous electron acceptor, such as oxygen,...
and semi-synthetic products), and a facility in India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
and additional sites in Italy
Italy
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
, Croatia
Croatia
Croatia , officially the Republic of Croatia , is a unitary democratic parliamentary republic in Europe at the crossroads of the Mitteleuropa, the Balkans, and the Mediterranean. Its capital and largest city is Zagreb. The country is divided into 20 counties and the city of Zagreb. Croatia covers ...
, Mexico
Mexico
The United Mexican States , commonly known as Mexico , is a federal constitutional republic in North America. It is bordered on the north by the United States; on the south and west by the Pacific Ocean; on the southeast by Guatemala, Belize, and the Caribbean Sea; and on the east by the Gulf of...
and the Czech Republic
Czech Republic
The Czech Republic is a landlocked country in Central Europe. The country is bordered by Poland to the northeast, Slovakia to the east, Austria to the south, and Germany to the west and northwest....
(development of high potency API).
TAPI's R&D focuses on the development of processes for the manufacturing of API, including intermediates, chemical and biological (fermentation), which are of interest to the generic drug industry, as well as Teva's proprietary drugs. The API R&D division also seeks methods to continuously reduce API production costs, enabling TAPI to improve its cost structure.
Manufacturing and technology
Teva has 21 API production facilities located in Israel, Hungary, Italy, the U.S., the Czech Republic, India, Mexico, Puerto Rico, Monaco, China and Croatia.TAPI’s holds expertise in a variety of production technologies, including chemical synthesis
Chemical synthesis
In chemistry, chemical synthesis is purposeful execution of chemical reactions to get a product, or several products. This happens by physical and chemical manipulations usually involving one or more reactions...
, semi-synthetic fermentation, enzymatic synthesis, high potent
Potency (pharmacology)
In the field of pharmacology, potency is a measure of drug activity expressed in terms of the amount required to produce an effect of given intensity. A highly potent drug evokes a larger response at low concentrations, while a drug of lower potency evokes a small response at low concentrations...
manufacturing, plant extract
Plant extract
Plant extract may refer to:* Herbalism and traditional medicine* Biopesticides...
technology, synthetic peptides, vitamin D
Vitamin D
Vitamin D is a group of fat-soluble secosteroids. In humans, vitamin D is unique both because it functions as a prohormone and because the body can synthesize it when sun exposure is adequate ....
derivatives and prostaglandins
Prostaglandin
A prostaglandin is any member of a group of lipid compounds that are derived enzymatically from fatty acids and have important functions in the animal body. Every prostaglandin contains 20 carbon atoms, including a 5-carbon ring....
. Also, its advanced technology and expertise in the field of solid state particle technology enables it to meet specifications for particle size distribution
Particle size distribution
The particle-size distribution of a powder, or granular material, or particles dispersed in fluid, is a list of values or a mathematical function that defines the relative amounts of particles present, sorted according to size...
(PSD), bulk density
Bulk density
Bulk density is a property of powders, granules and other "divided" solids, especially used in reference to mineral components , chemical substances, ingredients, foodstuff or any other masses of corpuscular or particulate matter. It is defined as the mass of many particles of the material...
, specific surface area, polymorphism
Polymorphism (materials science)
Polymorphism in materials science is the ability of a solid material to exist in more than one form or crystal structure. Polymorphism can potentially be found in any crystalline material including polymers, minerals, and metals, and is related to allotropy, which refers to chemical elements...
, as well as other characteristics.
Teva’s API facilities meet all applicable current Good Manufacturing Practices
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
(cGMP) requirements under U.S., European, Japanese, and other applicable quality standards. In some of the products that are sold in the U.S., TAPI utilizes controlled substances
Controlled substance
A controlled substance is generally a drug or chemical whose manufacture, possession, or use are regulated by a government. This may include illegal drugs and prescription medications ....
and therefore must meet the requirements of the Controlled Substances Act
Controlled Substances Act
The Controlled Substances Act was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain...
and the related regulations administered by the Drug Enforcement Administration
Drug Enforcement Administration
The Drug Enforcement Administration is a federal law enforcement agency under the United States Department of Justice, tasked with combating drug smuggling and use within the United States...
.
Products
TAPI produces approximately 300 active pharmaceutical ingredients covering a wide range of products, including respiratoryRespiratory system
The respiratory system is the anatomical system of an organism that introduces respiratory gases to the interior and performs gas exchange. In humans and other mammals, the anatomical features of the respiratory system include airways, lungs, and the respiratory muscles...
, cardiovascular, anti-cholesterol
Anti-cholesterol
Anti-cholesterol is a naturally occurring antibody to cholesterol produced by mammals. It is believed that this antibody serves a ‘housekeeping’ or protective role for the host animal, helping to protect the animal from harmful forms of cholesterol such as LDL and VLDL.-Modes of Action:An...
, central nervous system
Central nervous system
The central nervous system is the part of the nervous system that integrates the information that it receives from, and coordinates the activity of, all parts of the bodies of bilaterian animals—that is, all multicellular animals except sponges and radially symmetric animals such as jellyfish...
, dermatological
Dermatology
Dermatology is the branch of medicine dealing with the skin and its diseases, a unique specialty with both medical and surgical aspects. A dermatologist takes care of diseases, in the widest sense, and some cosmetic problems of the skin, scalp, hair, and nails....
, hormones
Hormone
A hormone is a chemical released by a cell or a gland in one part of the body that sends out messages that affect cells in other parts of the organism. Only a small amount of hormone is required to alter cell metabolism. In essence, it is a chemical messenger that transports a signal from one...
, anti-inflammatory
Anti-inflammatory
Anti-inflammatory refers to the property of a substance or treatment that reduces inflammation. Anti-inflammatory drugs make up about half of analgesics, remedying pain by reducing inflammation as opposed to opioids, which affect the central nervous system....
, oncology
Oncology
Oncology is a branch of medicine that deals with cancer...
, immunosuppressants
Immunosuppressive drug
Immunosuppressive drugs or immunosuppressive agents are drugs that inhibit or prevent activity of the immune system. They are used in immunosuppressive therapy to:...
and muscle relaxants
Muscle relaxant
A muscle relaxant is a drug which affects skeletal muscle function and decreases the muscle tone. It may be used to alleviate symptoms such as muscle spasms, pain, and hyperreflexia. The term "muscle relaxant" is used to refer to two major therapeutic groups: neuromuscular blockers and spasmolytics...
. Its API intellectual property
Intellectual property
Intellectual property is a term referring to a number of distinct types of creations of the mind for which a set of exclusive rights are recognized—and the corresponding fields of law...
portfolio includes over 1,200 granted patents and pending applications worldwide.