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Lisinopril
Dihydrate
INKE, S.A.
Lisinopril
Dihydrate
Lisinopril Dihydrate (INKE S.A.)
EXECUTIVE SUMMARY
GENERAL MARKET DATA
!Product Data!Patent Situation World wide!Market Analysis SPECIFIC DATA – Lisinopril Dihydrate (INKE S.A.)
!Chemical Description!Standard of Quality!Chemical Development Plan Lisinopril
Dihydrate
Executive Summary
Lisinopril Dihydrate (API): High quality available with industrial batches.
Experience with similar APIs (e.g. Enalapril Maleate)
Fast decision making and adaptation to customer requirements.
State of the art manufacturing facilities, complying with cGMP, FDA standards
and ISO 9001:2000, provided with the latest technologies and equipment.
No customer complaints as a result of high quality standard.
Technical and Regulatory support to our customers.
Lisinopril
Dihydrate
GENERAL MARKET DATA
Lisinopril
Dihydrate
General Product Data (I)
D r u g N a m e
W o r ld S t a t u s
P h a r m a S t a t u s
A c e m in A c e rb o n A la p ril C a ra c e C ip r il D iro to n IC I- 2 0 9 K Ir u m e d L - 1 5 4 8 2 6 L is o p re s s L o n g e s M K - 5 2 1 N o v a te c P rin il P rin iv il S e d o n te n s il S in o p ril T e n s o p ril T o n o ly s in V iv a te c Z e s tril Lisinopril
Dihydrate
General Product Data (II)
T h e r a p y D e s c r i p t i o n
T h e r a p y S t a t u s
A n t i h y p e r t e n s i v e , r e n i n S y m p t o m a t i c a n t i d i a b e t i c
P h a r m a c o l o g y
D e s c r i p t i o n
A n g i o t e n s i n I c o n v e r t i n g
T h e r a p y C o d e
P h a r m a c o l o g y C o d e

R o u t e o f A d m i n i s t r a t i o n R o u t e o f A d m i n i s t r a t i o n C o d e
A l i m e n t a r y , p o

I n d i c a t i o n
I n d i c a t i o n S t a t u s
D i a b e t i c c o m p l i c a t i o n , Lisinopril
Dihydrate
General Product Data (III)
Originator
Development Stage

Licensee
Lisinopril
Dihydrate
Patent Situation Worldwide (I)
Priority Country
Priority Date
C o u n t r y N a m e
C o u n t r y S t a t u s
Y e a r L a u n c h e d
L i c e n s i n g O p .
Lisinopril
Dihydrate
Patent Situation Worldwide (II)
C o u n t r y N a m e
C o u n t r y S t a t u s
Y e a r L a u n c h e d
L ic e n s in g O p .
Lisinopril
Dihydrate
Market Analysis
Global Market Size
IMS data's covering the period including from April 2004 through end Lisinopril
Dihydrate
SPECIFIC DATA
Lisinopril Dihydrate (INKE S.A.)
Lisinopril
Dihydrate
Chemical Description
(2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-phenylpropyl] amino] hexanoyl] pyrrole-2- The Active Ingredient Lisinopril dihydrate has three chiral centres and is optically active.
Lisin
Formoter opril
Dihydrate
General Properties
Practically insoluble in acetone and in ethanol.
Lisinopril Dihydrate melts at approximately 160 ºC.
Lisinopril
Dihydrate
Standard of Quality (I)
There has not been any description in the literature about polymorphic forms of Lisinopril dihydrate.
Specific Optical RotationWaterSulphated ash Lisinopril
Dihydrate
Standard of Quality (II)
According ICH Q3A and Q3C Guidelines
Remarks: Ethyl alcohol is defined as “Solvent with low toxic potential” according with ICH Q3C Guidelines.
Lisinopril
Dihydrate
Standard of Quality (II)
Lisinopril dihydrate contains not less than 98.5 % and not more than 101.5 % of C21H31N3O52H2O calculated according to Ph. Eur. <2.2.20> method.
Remark: Specifications of Lisinopril dihydrate manufactured in INKE S.A. are in
compliance with the EP monograph No. 01/2005:1120 corrected.
Lisinopril
Dihydrate
Chemical Development Plan
Synthesis Development
Validation of Analytical Methods
Customer File
Industrial Batches for DMF
DMF (in CTD Format)
Certificate of suitability Eur. Ph. (2006)
Process Validation (2005)

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