Lines of Operation

Lines of Operations

innovative

The Life of an Innovative Drug

Teva resolutely decided to leverage its outstanding scientific resources, global leadership and scale to develop new innovative products that will make a real difference in people's lives.

On average, 5,000 to 10,000 compounds need to be screened in order to discover a new organic molecule, peptide or protein that can be used to treat or cure a disease. It can take 10-15 years to develop an innovative drug and costs can rise to over $1 billion.

Regulators demand that innovative products show distinct advantages to already existing products. Consequently, costs of development consistently rise and development time continuously increases.

Discovery/
Research

An innovative drug is the result of a discovery of a new organic substance and the research of how it can be used to treat or cure diseases

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Chemistry
and
Manufacturing
Controls
(CMC)
Development

CMC assures that each element in a clinical trial is pre-checked and assessed in order to prevent the risk of using a flawed compound

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Pre Clinical
Testing

Pre-clinical trials assess the compound’s safety, ADME and PK

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Clinical Trials

Clinical trials are conducted in three main phases; each addresses different questions and determines whether the testing can proceed to the

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Regulatory
Approval and
Marketing

The regulatory authority reviews the regulatory package and reaches a final decision. Upon approval, marketing activities commence

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Production
and
Distribution

Production commences in compliance with Good Manufacturing Practice (GMP) regulations, and once completed, a new innovative drug is launched

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Post
Marketing
Surveillance
Phase 4

Teva conducts ongoing surveillance of innovative drugs' safety, adverse reactions and side effects to protect public health

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generic

Developing Generic Drugs - How Does It work?

Teva is a global leading generic pharmaceutical company and has one of the broadest product pipeline in the industry.

With: 54 pharmaceutical production plants; 21 API production facilities; Approximately 149 product applications awaiting final FDA approval; Approximately 62 first to file applications pending in the US; 1,103 generic approvals in Europe, as of December 2012; Approximately 2,131 marketing authorization applications pending approval in 30 European countries.

Teva aspires to be the first to market high quality, affordable, generic medicines. How do we do it?

Selection and
Preparation

Many factors are taken into account when considering whether to develop a generic drug

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Generic R&D

Teva has the largest generic R&D team in the pharmaceutical industry

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Bioequivalence

A generic drug should be therapeutically equivalent to its reference innovative drug. To ensure therapeutic equivalence, bioequivalence studies are conducted

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Regulatory Affairs

Obtaining a Marketing Authorization from the regulators confirms that the generic drug is of high quality, safe and effective

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Production and
Distribution

Teva's vast supply chain meets the most challenging deadlines, delivering high quality generic products by land, sea or air

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