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Pharmaceutical Encyclopedia 2ndtower

Pharmaceutical Encyclopedia 2ndtower

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Published by muji7
pharmacy 2nd edi
pharmacy 2nd edi

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Published by: muji7 on Sep 16, 2013
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03/15/2014

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PHARMACEUTICALMANUFACTURINGENCYCLOPEDIA
Second Edition
Reprint Edition
by
Marshall
SittigVolume
1
A-K
NOYES
PUBLICATIONS
Westwood,
New
Jersey,
USA.
 
Copyright
01988
by Marshall SittigNo part of this book may be reproduced
or
utilized inany form
or
by any means, electronic
or
mechanical,including photocopying, recording or by any informa-tion storage and retrieval system, without permissionin writing
from
the Publisher.Library of Congress Catalog Card Number:
87-31547
Printed in the United States
Published in the United States
of
America byNoyes PublicationsFairview Avenue, Westwood, New Jersey
07675
ISBN:
08155-1144-21098 7 65 43
Library of Congress Cataloging-in-PublicationDataSittig, Marshall.Pharmaceutical manufacturing encyclopedia.Includes bibliographiesand indexes.
1.
Drugs--Synthesis--Dictionaries.
2.
Chemistry,Phar maceu
t
i
a
I
-
Dictionaries.
I.
Title.
RS402.5.S58 1988 61g.191 87.31547
ISBN
08155-1144-2
 
Foreword
The worldwide pharmaceutical industry has
a
dollar
Sales
volume greater than
$100
billionwith
a
number of individual drugs boasting sales volumes of over
$100
million each. Indeedsome drugs have been called "blockbuster drugs"-those generating at
least
$300 million innew revenues each year. The profit margins in drug manufacture are higher than the rest
of
the chemical industry and, of course, research expenditures are huge in order to maintainposition and develop new drugs in this highly competitive industry.The presentday drug industry
is
one of rapid change.Patents
on
current best-selling drugs are expiring.
It
has been estimated that thetop
100
products in the marketplace will
all
come off patent (that
is,
the basicpatents
will
expire) in the period between 1973 and 1990.As patents expire, exclusivity of producing
a
trade-named product will pass andcompetitiveversions of the basic drug will be marketed under generic names
(or
other
new
trade names) by new manufacturers.
It
has been estimated that
40%
of
the
drugs
on
the market in 1990 will be generic drugs.New products will come on the market
as
New products are developed through research.Products now marketed in Europe and Asia attain approved statusby the
US.
Food and Drug Administration (FDA) and enter thehuge and lucrative American market.Information on patented processes offers
a
number of commercial opportunities:
(1)
The patent expiration date (in the
U.S.
usually 17 years after the patentissuance date cited) offers the opportunity to duplicate and practice thepatented process without
legal
conflict after expiration.
(2)
The statement of ownership of the patents affords the opportunity tolicense the patent in question from the patent holder.(3) The definition of the patented process offers the opportunity to an in-novative chemist to develop
a
process which bypasses the original patentclaims and offers
a
new legally clear route to an economically attractiveproduct.This encyclopedic work gives details
for
the manufacture of
1295
pharmaceuticals, nowbeing marketed
as
trade-named products somewhere in the world. The pertinent processinformation has been obtained from examples given in the pertinent patent literature(usually
US.
patents and sometimes British patents).In addition to the patentderived process information, references are also cited under eachdrug's entry to major pharmaceutical reference works where additional information can beobtained on synthesis methods and the pharmacology of the individual products.
V