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AET

API and Generics

Reaching goals together.


In an atmosphere of trust
and partnership.

Index
Chapter

Page

AET | Corporation

04 - 05

AET | API

06 - 09

AET | Laboratories

10 - 11

AET | Worldwide presence

12 - 15

AET | Generics

16 - 19

AET | Partnerships

20 - 21

AET | Business development

22 - 23

AET | Contact

24

03

Mission
We shall set the benchmark for successful
independent generic medicine development. What we
do, we do right and the passion of our people shall be
our partners guarantee. We will at all times provide
solutions that exceed best industry practice whilst
focussing on commercial value. Patients around the
globe will benefit from access to good value medicine

AET. Decades of experience


for enduring relationships.

that is developed and manufactured in supply chains


authorized by Health Authorities in the EU. We call
ourselves Tifis (shortened from Tiefenbacher) and we
take pride in doing our part to improve the health of
the world.

Founded 1963 in Hamburg by the Companys


namesake Alfred E. Tiefenbacher, AET has

Representing active pharmaceutical


ingredient (API) producers has provided

been growing successfully as the worlds first


exclusive API agency in the market for active
pharmaceuticals for 50 years.

the foundation for AETs growth into a


pharmaceutical company capable of
independently developing, registering and
supplying finished dosage form (FDF)
generic pharmaceuticals to marketing
organizations internationally. AET enjoys
an industry leading reputation for technical
excellence and service.

04

Vision
Change is our single constant helping us stay
ahead of global market developments. AET will
continue to transform to become the most recognized
brand for medicine development and medicine
provision to marketers throughout the world through
concentration on core competencies and expansion
of know how, service and science in every conceivable
area of generic research and development.

05

AET and active pharmaceutical ingredients.


A corporation growing through challenges.

Acquisition and marketing management


of API has been shaping the core business
for almost five decades. Through years of
effective collaboration with selected API
suppliers, AET has become one of the worlds
leading API agents.

Transparency, a long standing and profound


knowledge of the continuously changing API
market and its significance in healthcare, as well as
anticipation and flexibility when dealing with radical
changes in the industry have allowed AET to grow
continuouslythe
over
50 years.
throughout
lastthe
50last
years.

Through relationships with leading principals,


suppliers and clients based on successful and trusting
collaboration, AET has the experience and ability
to exceed the needs of the pharmaceutical and API
industries.

06

07

Transparency in the relationship between the


manufacturer, the commissioner and AET is of
paramount importance in delivering value to AETs
clients, and promotes trusting and open collaborations
that are best able to innovate and be efficient in
dealing with complex and challenging situations.

Nearly 50 years experience in procurement


management and superb information networks

AET as active ingredient representative.


At the interface of production and innovation.

have established AET as one of the most successful


API procurement companies globally. More than 50
carefully selected API manufacturers from around the
world provide AETs clients with API.

AET is a pioneer in the international active


pharmaceutical ingredient market. The
trusting relationships that AET enjoys with its
suppliers and commissioners have been the
key to its success. RECORDATI S.p.A., as one
example among many, has been represented
successfully by AET for over 40 years. Today,
AET represents nearly 20 international
API manufacturers, AETs Principals, the
word that has become a standard term
in the international API business since
its introduction to this use by Alfred E.
Tiefenbacher, along with so many of AETs
innovative business practices.

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09

The founding of AET Laboratories in


Hyderabad, India, in 2003 was a further
milestone on AETs successful path to an
integrated and prolific working corporation.
Since August 2006 the company operates
under the name AET Laboratories Pvt. Ltd.
At the Hyderabad site, highly motivated scientists and
technicians develop and document generics through
to validated approval and market launch.

The first EU marketing approval for AET was achieved

Key facts

in October 2006. The extension of the R&D centre to

+ State of the art R&D Lab for galenical & analytical

3,000 m2 was completed in August 2009. One year

development.

later, in September 2010, the 50th development

+ Pilot plant for bio batches and small scale

project was initiated. FDA and ANVISA inspection

manufacturing, sponsor of biostudies, and

will be initiated in 2012/2013.

compilation of dossiers for submission in Europe and


third countries in cooperation with AET, Germany
and Cyprus.

AET Labs. Research and development.


Integrated solutions for the generics market.

10

+ GMP Pilot Plant audited and approved in 2006 and


2009 by the German Health Authority
+ Scheduled inspections by ANVISA and the FDA for
2012/2013.

11

AET and Aegis Cyprus. Small-scale


production and expansion of AETs
service portfolio.
In autumn 2009 AET entered into a strategic
partnership with Aegis in Cyprus. With this step
AET secured a trusted partner for pharmaceutical
manufacturing, packing and analytics in southern
Europe. Additionally Aegis gives regulatory support
for early emerging markets by obtaining Certificates of
Pharmaceutical Products (CPP) in Cyprus.

AET Worldwide.
Local expertise supported by global resources.

Our internationally active customers use such CPPs


to register fast track in targeted markets of Africa,
South East Asia, Latin America and elsewhere. Further
to this, Aegis now also serves as co-marketing partner
for our clients. Given the existing, registered and

AETs global footprint.

ready-to-distribute brand in developing countries, our

AET has a history of excellence in service and

customers can enter into these markets or expand the

collaboration. Today AET is a fully fledged

existing product portfolio even faster than before.

pharmaceutical company with a portfolio of over 100


generic products developed in its own laboratories
and with partners that are licensed out to market

Key facts

leaders globally. AET is active in developing diverse

+ Capacity for manufacturing of solid dosage forms

pharmaceutical technologies and products.

+ Flexible for short-term supply requirements

Clients benefit from the true expertise of AET in first

+ Primary and secondary packaging with short change

to launch generic and OTC marketing authorisations,

over times

bulk or finished packed product supply from robust

+ Extensive and enlarged EU batch control and EU

and cost effective supply chains, CTD dossiers for

release capabilities

submission in territories outside the EU/EEA, expert

+ Large, growing product portfolio ready-to-use for

project management and support (Quality Audit, IP

co-marketing purposes in Africa, S-E-Asia and other

Case Management & Regulatory Affairs).

developing regions

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13

AET Brazil. Supporting Brazils leading


pharmaceutical companies.
Taking into consideration the promising development
and the high potential of Brazil as a pharmaceutical
market, AET since one year has established being
present with AET staff in Sao Paulo. Our licensing
managers are located in M. Cassabs offices and with

AET Malta. Early


market entry support.

this cooperation are taken by the helping hand of our

Using the exceptional situation of the Republic of Malta

development, registration and supply services to those

in terms of intellectual property, AET Malta materialises

Brazilian companies, we do not serve already from

the possibility to act and serve freely for timely

our head office in Germany. Furthermore we expand

launches for non-protected markets. The perfect

into the most promising countries like Argentina

pharmaceutical infrastructure, the logistic benefits

and Venezuela from Sao Paulo, making use of the

in terms of sea and air travel and the participation of

high standards of ANVISA that are widely accepted

Malta as member state of the EU more than justified

throughout Latin America.

local partner. This way we can provide comprehensive

the incorporation of AET Malta in 2010.

Establishing a global footprint.


Through local support.

14

AET China. Representative office in Beijing.

AET. USA. Establishing a presence


in a dynamic generics market.

AET has recently established local representation

AET has established local representation via Byron

in Beijing to facilitate collaboration with API

Chemicals Ltd. to serve the local US companies. Our

manufacturers, development partners and customers

key accounts however are maintained via our global

in the market, and to provide local capabilities in

partnering approach from Germany. The US as one

sourcing, regulatory support and market intelligence.

of the most established generic markets still gives us

This builds on AETs excellent network in one of the

enough room to establish ourselves as high quality

worlds leading developing markets.

provider of globally set up generic developments.

15

AET and finished dosage forms. Active


collaboration for pharmaceutical innovation.
AET is an active collaborator in all fields of
pharmaceutical innovation, from generic
drugs through biosimilars to novel product
development. Successful and profitable
collaborations with companies from local
distributors through to big pharma are
supported by a flexible and innovative
approach to licensing and partnering.

Building on its success as an agent for renowned API

The commissioners also profit from the knowledge and

producers, AET expanded into the rapidly developing

experience of AET in sustained marketing of a generic.

market for generics in the 1990s. Today, with its far-

Directly after the successful launch of a product,

reaching expertise, AET counts among the leading

AET marketing experts examine its future chances

European corporations in the backwardly integrated

and growth potential in the regional markets. From this

generics development sector.

they develop applicable strategies for the entire supply


chain, in order to sustainably secure the life cycle of

At AET Labs, and with selected international partners,

the product.

AET develops tailor-made products beginning with

The level of both experience and innovation

development via documentation and registration

has led to AET being partner of choice for


many of the worlds leading pharmaceutical
companies.

through to production, packaging and just-in-time

16

delivery.

17

AET shares its extensive expertise with


world leading formulation and API synthesis
companies to co-develop generic drugs for
international markets. AET is involved in all
aspects of the development progress from
chemical, galenical and IP aspects, through
to identifying the key regulatory influences
both partners
and targets, to ensure that partners
obtain
obtain
thevalue
mostfrom
value
from
the collaboration.
the
most
the
collaboration.

AET and co-development partnerships.


Development, registration and
commercial supply in one.

Key facts
+ Professional project setup
+ Transparent project management
+ Pharmaceutical development expertise
+ Regulatory affairs expertise and support to receive
timely marketing authorisations
+ Intellectual property advice and guidance
+ Technical support and quality
+ Innovative licensing approaches
+ Just-in-time launch management
+ Cost and efficiency driven supply chain

Partners enjoy expert IP advice on the formulation

management

and submission routes for a product: AET has


frequently been first to market based on IP strategy in
submission.

AET has in-depth experience in the development


and registration of dossiers in all indication areas and
with complex delivery technologies. We have many
years of experience gaining marketing authorisations
worldwide with a large, multilingual and highly qualified
team.

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19

Reasons to partner with AET:


+ Extensive pipeline planned submissions for more
than 40 molecules worldwide in 2012
+ Portfolio building for long term growth in global markets

Innovative licensing and collaboration are


at the centre of the AET business, enabling
companies to build their drug portfolios in
partnership with the leading independent
specialist.

+ Consideration of local markets needs: stability zone IV


studies, inspected supply chains, local BE-studies
+ Full assortment available as registered or about-tobe-registered product in local markets
no restriction to indications or forms
+ Provision of branding registered and approved
brand names packed in locally adapted secondary

AET works hand in hand with clients to identify client


product opportunities, creating targeted strategies to
ensure long-term growth in local and global markets.

packaging for growth markets


+ High value justification in emerging markets due
to extensive documentation, exceeding local
requirements but setting standards hard to

Clients reach agreement with AET on contracts


that support a profitable, secure and flexible

copy for local suppliers


+ Local conditions highly automated and EU

framework for the client, taking into consideration

approved processes provide the basis for being

all requirements.

internationally competitive in basically every


market setup

AET and business development. Comprehensive


services for successful market entrance.

20

AET offers a comprehensive service from development


through registration to supply and maintenance,
delivering internationally, allowing clients to focus on
successful own brand marketing.

+ Fast market access with granted and available MAs


in all 27 EU member states
+ More than 1000 MAs to come until 2012 or already
available in 27 EU countries

21

AET offers its clients tailored support


throughout the complete life cycle of a
product to secure a punctual launch of a
competitive product at excellent quality. This
enables our customers to keep costs and
risks at a minimum while at the same time
relying on AETs professional project setup.

AET and generics. At the service


of international healthcare systems.

Common Technologies

Areas of special interest

+ Tablets (immediate and

+ Cytotoxic drugs

modified release,

+ Hormones

chewable, ODT)

+ Herbal drugs

+ Capsules (hard, soft gel)

+ OTC drugs

+ Solutions

+ Controlled drugs

+ Injectables (lyophilised and solutions)

+ High potent drugs

+ Ophthalmics

+ New combination products

+ Oral dissolving films (ODF)

+ New delivery systems

+ Patches

+ Inhaler technologies

+ Semisolids

+ Modified release injectable products

+ Inhaled therapies

+ Biosimilars

Printed: September 2012

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23

ALFRED E. TIEFENBACHER (GmbH & Co. KG)


Van-der-Smissen-Strasse 1
22767 Hamburg
Germany
Phone +49 (0) 40 - 44 18 09 - 0
Fax +49 (0) 40 - 44 18 09 - 26
Mail info@aet.eu
Web www.aet.eu