Those pioneering days ...

Page 2
60 years of EUDRAGIT
Page 8
The EUDRAGIT Award
Page 14
EUDRAGIT
history at a glance
Page 15
Strategic outlook
Page 18
EXCiPACT
certication
Page 19
Upcoming events
Page 20
CONTENT
Editorial
Celebrating a star in our family
Dear Readers,
That star was born six de-
cades ago from the idea that
polymers derived from esters of
acrylic and methacrylic acid
would be more eective and re-
liable than natural materials for
coating tablets. What our re-
searchers in Darmstadt couldnt
anticipate at that time was the
eect this breakthrough would
have on the global pharmaceuti-
cal industry.
As we celebrate the 60
th
an-
niversary of EUDRAGIT, we
look back at a success story that
continues to this day. It tells of
pioneering spirit and persever-
ance, of creativity and commit-
ment. These themes come
through in this issue, especially
in the stories told by some of our
pioneers (having joined the
EUDRAGIT team in 1980 I have
the honor of counting myself
among them) who played a part
in making EUDRAGIT what it
is today: not just a range of
products that are central to
pharmaceutical development
and manufacturing on a global
scale, but a brand synonymous
with quality, consistency, inno-
vation and commitment to the
customer.
Speaking of which, the ar-
ticle on our future role in the
customers value creation chain
shows just how much we have
evolved from a supplier of poly-
mers for excipients to a full-
fledged partner and solu-
tions provider to pharmaceutical
companies. And the new
EXCiPACT standard for ex-
cipient quality assurance, de-
signed to save our customers
audit time and costs, is just the
most recent example of a prag-
matic value-add for the pharma
industry.
We have learned so much in
the past sixty years, gaining a
deeper and broader understand-
ing of customer and market
needs, and coming up with ever
better products, advanced tech-
nologies and extended services
to meet them. What better way
than to start the rst chapter of
the next sixty than with the
EUDRAGIT Award for out-
standing research papers and
posters published by young re-
searchers in 2014?
Although the many achieve-
ments in such a short time ll all
of us at Evonik with pride, it has
never been in our nature to rest
on our laurels. The future, no
doubt, holds many new chal-
lenges in store for us, but one
thing is certain: we will be able
to meet them through our com-
mitment to partnership and in-
novation.
Enjoy the read!
Yours,
Hans-Ulrich Petereit
The newsletter of Evoniks Pharma Polymers & Services product line Issue 1 | 2014
2
Pharma Polymers News 1 | 2014
Those pioneering days
ester copolymerisates to produce lm coatings that would
remain insoluble across the entire pH spectrum, essentially
ensuring pH-independent time-controlled sustained release
eects. Until then, all EUDRAGIT types were available only
as a 12.5-percent isopropanol solution or in a mixture with
acetone, and manufactured using a solution polymerization
process. Substance polymerization subsequently enabled
higher product purity. And to address our customers hand-
ling and processing issues, we made solid forms available as
granules and powders, too.
We also believed in avoiding organic solvents long before it
became the standard, so we developed emulsion polymeriza-
tion in 1972 to create aqueous dispersions and enable solvent-
free coating technologies a key industry breakthrough. Ever
since those early days, in fact, we never stopped pioneering.
And the fact that our functional polymers are actually better
known around the world by their brand name than by their
chemical designation says one thing: its whats in the package
that counts, not on it.
In 1954, we combined the Ancient Greek syllable eu
(pronounced oi), meaning good, with the French
drage as synonym for coating and rounded it o
with an it to arrive at EUDRAGIT. It made sense,
described the product, and had a nice, sophisticated
ring. Trust me, Oi-drah-git really sounds great in
German. Little did we know back then that it was a
tongue twister in just about every other language, and
that especially English-speaking customers, business
partners and even researchers in our own labs quietly
wondered how on earth a product could be called
You drag it! However, time and again EUDRAGIT
would prove that substance trumps form.
In the rst decade alone, EUDRAGIT widened the application
horizon for drug developers and manufacturers with inno-
vative functionalities, from gastro-resistance to moisture
protection as well as to taste and odor masking. Customers
obviously cared more about how our products solved their
formulation problems than what they were called. In 1968, we
introduced quaternary amino groups in methacrylic acid
Whats in a name?
Dr. Klaus Lehmann on the EUDRAGIT brand
Those pioneering days
Every great product begins with a pioneering breakthrough that upends the conventional wisdom of its time.
What makes it an enduring success, however, is the sustained team eort afer that rst spark of imagination.
Its not just about brains and perseverance, either. Rather, it has much to do with a shared passion for rising to
seemingly insurmountable challenges and a knack for thinking outside the box. Here are a few chapters of the
EUDRAGIT success story, as told by some of the pioneers who accompanied the business over many years and
brought distinction to it.

Join Dr. Heide Bssler, Dr. Klaus Lehmann, Hans-Ulrich Petereit, Dr. Hema Ravishankar, Dr. Brigitte Skalsky and
Wolfgang Weisbrod on a trip down memory lane as they recall their adventures in building the EUDRAGIT brand.
3
Pharma Polymers News 1 | 2014
In the early days, demonstrating new products and formu-
lation concepts to our customers or providing on-site sup-
port with processing issues usually meant hopping behind
the wheel or on a train. Gradually, however, as business
picked up outside Germany, especially overseas, con-
tinuing to provide the same high level of dedicated and
hands-on service would create unexpected challenges.
EUDRAGIT had established a completely new quality level
and opened a whole new world of possibilities to formulators
and manufacturers for coating their drugs by using fully
synthetic polymers instead of natural organic substances.
At the same time, pharmaceutical manufacturing technolo-
gies were making strides, too. Just to name one example:
Coaters with atomizing air nozzles were much better and
safer at spraying organic EUDRAGIT suspensions than
single substance nozzles. However, the latter was most ofen
the norm on our customers production lines. Wed then
have discussions with users and equipment manufacturers
about changing the spraying conditions, which also involved
lower processing temperatures and spray pressures com-
pared to the traditional cellulose coatings. And later, when
we introduced aqueous polymer dispersions to reduce the
use of organic solvents a signicant advance in terms of
health and safety we had to familiarize our customers
with new handling and processing parameters. Not to forget
that in those early years, we were also looking to tap the
Those pioneering days
No time for jet lag
Hans-Ulrich Petereit on international
product support
potential for EUDRAGIT applications in other pharmaceu-
tical manufacturing processes besides coating wet gran-
ulation, direct compression, roller compaction are just a few
examples. Besides making these formulation concepts avail-
able to the market, we made it a point to also provide model
formulations.
Support works best face-to-face, and we were seeing cus-
tomers in the US one week, in South America the next, and
in Asia the week afer. Remember, this was before e-mails,
teleconferencing and all the collaborative solutions made
available by the internet. It was also before frequent yer
programs. We worked a lot with translators and interpret-
ers in those days, but sometimes explaining how things t
together was only possible with a pantomime. And I can also
assure that, as much as we looked up local customs and eti-
quette before each trip, we had a few cultural close calls
but that is another story.
Above:
Hans-Ulrich Petereit at the International Agency Meeting October 1993
Right:
The headquarters, 1978: old Rhm Pharma Building in Weiterstadt, Germany
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Pharma Polymers News 1 | 2014
Those pioneering days
When I joined the team in 1976, we were pioneering
waterborne dispersions for polymer coatings to replace
organic solvents. It was clear that these new systems
were healthier and safer, and that in the long run they
would be more cost-eective as well. But they also made
coating formulations at the beginning more complex.
My job was to assist customers in transitioning to aque-
ous dispersions at their sites. I cant remember how ofen
I had to deal with clogged nozzles on coating machines
and colorful blotches on my lab coat, but Ill never forget
the shared feeling of accomplishment afer solving a
tough challenge together with the team on the customer
side and getting the thumbs up afer the nal test.
Deadlines were sometimes pretty tight.
As our aqueous recipes and processes unfolded their poten-
tial for making things easier, saving time and, most impor-
tant, reducing downtimes, the pharma industry increasingly
shifed away from organic solvent-based systems. Coating
equipment manufacturers improved the eciency and reli-
ability of application and drying processes, too, so we kept
innovating with new polymer systems. Today, aqueous sys-
tems are used 80 to 90 % of all coating applications. In the
1970s, it was more like 30 to 50 %.
Clogged nozzles?
No problem!
Wolfgang Weisbrod on
Technical Customer Service
I can safely say that the quality of our technical support is
only partly the product of everything we learned in our labs,
be it through systematic scientic research or, as it also
happened, by occasion. It comes from our view that we all
Evonik, our customers and the academic community
benet from a collaborative approach. Over the years, pro-
viding the best possible technical service has always been
central to our eorts, both in our labs and at customer sites,
on small batches as well as for commercial scale. Thats also
why we have set up a global network of Tech Service Centers
with 12 labs in 12 countries to be where our customers
are.
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Pharma Polymers News 1 | 2014
Those pioneering days
Weve come a long way since 1973, when I joined the
team. And not just in the area of Quality Control.
Imagine, fresh out of university, I was the only female
chemist amongst about 100 at Rhm, the company that
later became Degussa and ultimately Evonik ...
In those days, batch control was usually limited to checking
only a few product characteristics, such as dry substance and
acid value, and application engineering aspects, such as lm
formation. As drug safety standards were getting tougher,
however, we also conducted complex analyses, such as de-
termining molecular weight and residual monomers.
Speaking of which, one morning at breakfast I mentioned
the challenges our team was facing to reduce residual mono-
mer content in a specic EUDRAGIT grade to my husband,
who was also at Rhm in polymer dispersion research. We
could develop a modern emulsion polymerization process
followed by spray drying, he suggested. And thats how
three new EUDRAGIT products the market had been wait-
ing for came to be over tea and toast.
Although the Good Manufacturing Practice (GMP) guide-
lines drafed by the World Health Organization (WHO) be-
came a regulatory requirement in the US in 1978, it would
be 1985 before they were adopted in Germany and 1989
throughout Europe. By then my job was much more complex:
batch control had evolved into quality assurance for the en-
tire chain, from product and process development to produc-
tion and analytics all the way to approval and registration
for both nished drug products and raw materials.
Looking back, my objective was always to keep pace with
rising quality requirements and ensure our great products
would endure. Shortly before retiring from the company, I
remember seeing on the news that Britains Queen Mum had
turned 100. We had a QC meeting the next day and I men-
tioned that EUDRAGIT should last at least as long, too. Im
happy to see that we are well on track.
The proof is in the batch
Dr. Heide Boessler on Quality Control
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Pharma Polymers News 1 | 2014
Lab opening 2003, India
Thats not exactly what it said in the ad that caught my
attention in the Times of India back in 2001, but, in hind-
sight, that would have been just as appropriate. India was
fast becoming a force in pharmaceuticals and the plan was
to establish EUDRAGIT in the market early on.
And that meant setting up a local organization pretty
much from scratch. I was working in the mainstream
pharma industry at the time and ready for a new chal-
lenge and at rst skeptical as to whether R&D at an
excipient supplier would be exciting enough. Drug devel-
opment was where the action was, not delivery systems.
Or so I thought. That was almost feen years ago.
I went to work setting up a lab with a team of six researchers.
Any constraints in those pioneering days were made up for
with creativity, tenacity and a commitment to our values and
our customers. We also shared a vision of transforming the
relationship between drug developers and excipient suppliers
into a mutually benecial partnership. Our high quality tech-
nical service enabled customers to considerably reduce their
time to market, strengthening our reputation and helping us
grow our business as well.
Five years into the job, the vision of EUDRAGIT growth in
India was realized, laying the foundation for integrating our
lab in India into the global structure and cementing its role
as a center of excellence for oral drug delivery systems and
state-of-the-art technologies both regional and international
customers benet from. And their readiness to try new for-
mulations using EUDRAGIT continues to be nothing short
of overwhelming.
Looking back, I believe that our collaborative approach to
meeting formulation development and drug manufacturing
challenges may have felt like a breath of fresh air to our cus-
tomers. Actually, partners is the better word.
Wanted: vision sharer
Dr. Hema Ravishankar on EUDRAGIT in India
Those pioneering days
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Pharma Polymers News 1 | 2014
Our rst coating course for EUDRAGIT customers dates
back to 1974. From the outset, the emphasis was on
combining scientic presentations with hands-on assign-
ments. And that meant raiding our own lab which wasnt
that big to begin with for any equipment that even
remotely had to do with coating and carting it o to the
training room.
The international course with 50 to 60 participants promptly
became an annual aair, so our researchers eventually got
used to nding a note on the door once a year with Youll
have your equipment back tomorrow, promise! We were
getting great feedback from customers who attended the
course, so even if some colleagues grumbled a bit at rst,
everybody was ultimately happy to pitch in. Truth be told,
sharing knowledge through scientic and practical seminars
was a groundbreaking approach for a commercial company
in those days.
In 2002, when I joined as Head of Tech Services, we held
two seminars a year the traditional one in English of
course, and one in German with a greater focus on practical
training. Over the years, they grew in number and scope,
attracting the whole spectrum of pharmaceutical proles:
researchers and formulation scientists, application and pro-
cess engineers from pharma companies, and experts from
the scientic community.
This year, as we celebrate 60 years of EUDRAGIT and 40
years of EUDRAGIT seminars, we expect to welcome more
than 1,000 participants to over thirty seminars and work-
shops in close to twenty cities around the world.
Im always amazed at the enthusiasm and interest the par-
ticipants bring to each event. Young professionals fresh out
of university, seasoned researchers and senior experts
theyre all keen to learn more and develop new and better
drugs and delivery systems. Our team fully shares that pas-
sion. Every seminar is a highlight and everybody there feels
the special spirit, the creative energy.
Those pioneering days
Anybody have a coating
pan to spare?
Dr. Brigitte Skalsky on EUDRAGIT
Seminars & Workshops
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This year, we celebrate the 60th
anniversary of EUDRAGIT. As a
company at the forefront of innovation,
our focus has always been on polymer
research and application development.
For this reason, we wish to mark this
important milestone with a scientic
award for university students.
Are you publishing a paper or
poster in 2014 that centers on the role,
functionality, application or potential of
EUDRAGIT polymers? On ways they
make things easier for drug developers,
formulators or manufacturers? Or en-
hance drug bioavailability and ecacy?
Or improve patient compliance and qual-
ity of life? Or open new horizons in un-
discovered territory?
In that case, the EUDRAGIT Award
could put you and your ideas on the map.
And a cash prize in your pocket
Share a dose of your creativity with
EUDRAGIT!
The EUDRAGIT Award release your creativity!
Terms and conditions of entry for the EUDRAGIT Award
Applying authors must be matriculated undergraduate, graduate or doctoral
students at the time the published research work has been conducted.
University and scientic supervisor have to be named.
Only papers and posters published between January 1 and December 31, 2014
are eligible for the award.
The award will go to the best poster and best paper from each of these
three regions: Asia, Americas, Europe/Middle East/Africa.
The cash prize for the best poster is 1,000. For the best paper 1,500.
All entries must be submitted in PDF format including publication date and
location to eudragit-award@evonik.com
The deadline for all submissions is December 31, 2014.
The winners will be notied until April 2015.
Entrants may not be employees of Evonik Industries AG or any of its
aliates or subsidiaries.
All award decisions are nal and binding.
14
Pharma Polymers News 1 | 2014
When our researchers introduced the
rst methacrylates for gastro-resistant
lm coatings in the early 1950s many
pharmacies were still making their own
drugs. By April 1954, EUDRAGIT had
become a registered trademark and
was clearly headed for success.
Today, one couldnt imagine the phar-
maceutical industry without the func-
tional EUDRAGIT polymers. They pro-
tect drugs against light and moisture,
mask their smell and taste, and can con-
trol when or over which period of time
the active ingredients are released from
the dosage form. In addition to a broad
o-the-shelf product portfolio, Pharma
Polymers & Services now also oers to
develop customized polymers as well as
drug delivery systems.
EUDRAGIT
history at a glance
EUDRAGIT patent application 1952
15
Pharma Polymers News 1 | 2014
Formulations development laboratory 1977 The rst EUDRAGIT brochures
Formulation development lab 1977
EUDRAGIT ad from 1983
EUDRAGIT Symposium Pharma 1983
16
Pharma Polymers News 1 | 2014
Practical session at EUDRAGIT Symposium Pharma 08
th
of February 1983
Trade show booth at Interphex, Japan, 1986
Print promotion from the 1980s
Practical session at EUDRAGIT Symposium Pharma 1983 EUDRAGIT product packagings from the 80s
17
Pharma Polymers News 1 | 2014
Turning 60 and getting younger by the day
Strategic outlook
Over the course of six decades, our
innovative drive has continually set
the benchmark for oral solid dosage
forms. To pharmaceutical companies
around the world, EUDRAGIT has
become synonymous not only with
excipients that open new possibilities
for the controlled release of their
drugs, but also with a proximity and
partnership approach that underscores
our commitment to our customers
success. Over the years we have
developed an understanding of
the market that enables us to react
to emerging needs with the right
products and services while always
keeping a focus on quality, consistency
and reliability.

The unique added value we provide
is what enabled us to evolve from an
excipient supplier to a partner of the
pharmaceutical industry, and we will
keep building on our core strengths. We
intend to further strengthen our global
tech service network to deliver compre-
hensive, best-in-industry support where
our customers are, and to harmonize
global standards with regional and
local requirements. We also remain
committed to providing the regulatory
support and toxicological expertise that
have become our hallmarks.
On the product side, we are widening
the array of options, including tailored
polymers to address particular customer
formulation needs. The same goes for
innovative EUDRAGIT applications that
are specically being developed for ad-
vanced drug delivery systems. In terms
of services, we will continue oering
the targeted support our customers
want along with maximum exibility
regarding the scope of our involvement
from feasibility studies to formulation
development, from process optimization
and clinical supply to scale up and pro-
duction support.
Aligning our product and service
portfolio with our customers value
creation processes results in compelling
solutions in several key areas. New
functional polymers, advanced formula-
tions and smarter technologies, for
instance, optimize the bioavailability
of next-generation, highly potent ac-
tives where poor solubility is a major
issue. And last not least, Quality by
Design is another area we are focusing
on to meet the demand of our clients for
more comprehensive support.
For sure, we cant anticipate what the
next 60 years will bring in terms of new
challenges. But we do know this: the
pioneering spirit, deep application know-
how, and the strong commitment to our
customers that brought us this far will be
our guide as we explore new horizons.
Dr. Thomas Riermeier
Vice President
Pharma Polymers & Services
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Pharma Polymers News 1 | 2014
EUDRAGIT certied to new standard
Quality assurance without audits:
the new EXCiPACT

label means real

added value for EUDRAGIT customers.
Unlike companies that manufacture
drugs and active pharmaceutical ingre-
dients, for which there is a regulatory
requirement to meet current Good Man-
ufacturing Practices (cGMP) standards,
excipient producers until recently were
under no legal obligation to abide by the
GMP guidelines for bulk pharmaceutical
excipients issued by the International
Pharmaceutical Excipients Council (IPEC
GMP guidelines, for short); neither could
they seek ocial certication. The only
way pharmaceutical companies could
verify that the excipients they sourced
met the high quality and safety standards
that applied to their own products was to
conduct their own on-site audits at the
excipient manufacturers premises a
very time-consuming and expensive ex-
ercise for all parties involved.
Reducing costs and complexities is
always a good idea. That is why both
sides, excipient producers and pharma-
ceutical companies, got together to es-
tablish a uniform standard and certica-
tion system for excipients. It was
developed in close concert with experts
from all the major international industry
organizations the European Fine
Chemicals Group (EFCG), the Interna-
tional Pharmaceutical Excipients Coun-
cils (IPEC) Europe and Americas, the
European Association of Chemical Dis-
tributors (Fecc), and the Pharmaceutical
Quality Group (PQG). In January 2012,
the EXCiPACT label was born, dening
the product and process quality stan-
dards that excipient manufacturers must
fulll to eliminate the need for on-site
auditing by their customers, i. e. pharma
companies. The fact that candidates must
already be ISO 9001 certied is a pre-
requisite that adds considerable weight
to the label; Evonik also has 14001 certi-
cation.
The lengthy and thorough process of
certifying label candidates began in
earnest in early 2013. In late 2013, two
accredited auditors scrutinized the
EUDRAGIT manufacturing and quality
assurance facilities of Pharma Polymers
& Services in Darmstadt over a two-and-
a-half day period. The auditors pro-
ceeded with unprecedented thorough-
ness, says Dr. Thomas Brendel, Head of
Quality Assurance for the Pharma Poly-
mers & Services Product Line at the
Health Care Business Line. In January
2014, Evonik then became one of the rst
companies to obtain the label for its
EUDRAGIT product range and so far
the only one where methacrylates are
concerned. As of September 2014, just
ten companies have been certied.
When EUDRAGIT customers request
an audit, Evonik will now be able to
propose an attractive alternative: the
EXCiPACT certicate. They can also
obtain a copy of the comprehensive
certication report afer signing a non-
disclosure agreement. EXCiPACT
truly marks a step change because, in ad-
dition to saving considerable amounts
of time and money, our customers in the
pharma industry now also have the reas-
surance of certied quality for products
that are key to their activities, adds Dr.
Brendel.
mdc medical device certification GmbH
Kriegerstrae 6
D-70191 Stuttgart, Germany
Phone: +49-(0)711-253597-0
Fax: +49-(0)711-253597-10
nternet: http://www.mdc-ce.de
Standard Compliance Certificate
We certifythat
Evonik Industries AG
Werk Darmstadt / Weiterstadt
Kirschenallee
64293 Darmstadt
Germany
for the scope
Manufacturing, testing, packaging, storage and rel ease of
Acryl ate/Methacrylate-copolymers (trade name: EUDRAGIT

) used as
functional excipients for controlled release of acti ve pharmaceutical ingredients
for oral and dermal dosage forms
has introduced and applies a
Management System
according to the
EXCiPACT
TM
Certification Standard for
Pharmaceutical Excipient Suppliers (www.excipact.org):
Good Manufacturing Practice
This Certificate is only valid in conjunction with a valid ISO 9001 certificate
Valid from 2014-01-27
Valid until 2017-01-26
Registration no. D1372800001
Report no. E-D13728_2014-01-27
Stuttgart 2014-01-27
Head of Certification Body
19
Pharma Polymers News 1 | 2014
Upcoming events
Log in to our online platform e-Lab at www.evonik.com/e-lab to register for our workshops
Imprint
This is a publication of
Evoniks Pharma Polymers
& Services product line
All dates and locations
are subject to change
Published by
Evonik Industries AG
Kirschenallee
64293 Darmstadt
Germany
+49 6151 18-4019
+49 6151 18-3520
eudragit@evonik.com
www.eudragit.com
www.resomer.com
www.evonik.com/e-lab
Responsible for content
Dr. Brigitte Skalsky
Layout
MLW KommunikationsForm
GmbH Werbeagentur,
Worms
= registered trademarks
EUDRAGIT and RESOMER
are registered trademarks
of Evonik Industries or its
subsidiaries.
Come and meet us at:
CPhI Paris Nord Villepinte, France
from 7
th
9
th
of October
AAPS San Diego Convention Cen-
ter, USA from 2
nd
6
th
of November
and receive your
EUDRAGIT 60 years gif!
20
Pharma Polymers News 1 | 2014
Trade shows with
Evonik participation
EUDRAGIT
workshops
December
Dec 13 16
TERMIS America
Washington, DC, USA
September
Sep 25 26
MEDTEC China
Shanghai, China

Sep 26
EUDRAGIT &
Health Care Workshop
Ahmedabad, India
Sep 30 Oct 2
Powtech / TechnoPharm
Nrnberg, Germany
November
November
EUDRAGIT
Advanced Workshop
Singapore
Nov 2 6
AAPS Annual Meeting
& Exposition
San Diego, CA, USA

Nov 13
EUDRAGIT
Basic Workshop
Pakistan
October
Oct 1
EUDRAGIT
Basic Workshop
Indonesia
Oct 3
EUDRAGIT
Basic Workshop
Thailand
Oct 7 9
CPhI Worldwide
Paris, France
Oct 9
EUDRAGIT &
Health Care Workshop
Dhaka, Bangladesh
Oct 14
EUDRAGIT
Advanced Workshop
Piscataway, NJ, USA
Oct 14 17
ETIF
Buenos Aires, Argentina
Oct 16
EUDRAGIT
Compact Course
Zaragoza, Spain
Oct 17
EUDRAGIT Advanced
Technologies Workshop
Mumbai, India
Oct 21
EUDRAGIT
Basic Workshop
Beijing, China
Oct 31
Symposium on Particle
Preparation & Design
Japan