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Salmeterol
Xinafoate
INKE, S.A.
Salmeterol
Xinafoate
Salmeterol Xinafoate (INKE S.A.)
EXECUTIVE SUMMARY
GENERAL MARKET DATA
!Product Data!Patent Situation World wide!Market Analysis SPECIFIC DATA – Salmeterol Xinafoate (INKE S.A.)
!Chemical Description!Standard of Quality!Chemical Development Plan Salmeterol
Xinafoate
Executive Summary
Salmeterol Xinafoate (API): High quality available with industrial batches.
EDMF in CTD FORMAT.
Own alternative process patent
Experience with similar APIs (e.g. Formoterol Fumarate)
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.
Salmeterol
Xinafoate
GENERAL MARKET DATA
Salmeterol
Xinafoate
General Product Data (I)
Drug Name
World Status
Pharma Status
Aeromax Arial GR-33343G GR-33343X Salmetador salmeterol hydroxynaphthoate Serevent Serevent Accuhaler Serevent Diskhaler Serevent Diskus Serevent Surehaler Serobid SN-408 Ultrabeta Salmeterol
Xinafoate
General Product Data (II)
Therapy Description
Therapy Status

Pharmacology
Description

Therapy Code
Pharmacology Code

Route of Administration Route of Administration Code
Respiratory, inhaled

Indication
Indication Status
Salmeterol
Xinafoate
General Product Data (III)
Originator
Development Stage

Licensee
Salmeterol
Xinafoate
Patent Situation Worldwide (I)
Priority Country
Priority Date
C o u n try N a m e
C o u n try S ta tu s
Y e a r L a u n c h e d
L ice n sin g O p .
Salmeterol
Xinafoate
Patent Situation Worldwide (II)
C o u n try N a m e
C o u n try S ta tu s
Y e a r L a u n c h e d
L ic e n s in g O p .
Salmeterol
Xinafoate
Market Analysis
Global Market Size
IMS data's covering the period including from April 2004 through end Salmeterol
Xinafoate
SPECIFIC DATA
Salmeterol Xinafoate (INKE S.A.)
Salmeterol
Xinafoate
Chemical Description
(1RS)-1-[4-Hydroxy-3-(Hydroxymethyl)phenyl]-2-[[6(4-phenylbutoxy)hexyl]amino]ethanol 1-hydroxynaphthalene-2-carboxylate.
The Active Ingredient Salmeterol Xinafoate has one chiral center. It is a racemic mixture of the two enantiomers with the configurations R and S.
Salm
Formote et
er
ol Fumarate ol
Xinafoate
General Properties
Slightly soluble in ethanol, isopropyl alcohol and in chloroform. . Salmeterol Xinafoate melts at about 137-138 ºC.
Salmeterol
Xinafoate
Standard of Quality (I)
Two polymorphic forms of Salmeterol Xinafoate have been described in the literature. The Salmeterol Xinafoate manufactured by INKE S.A. corresponds to the polymorph I, because it is the most thermodynamically stable form at room temperature.
Salmeterol
Xinafoate
Standard of Quality (II)
According ICH Q3A and Q3C Guidelines
Isopropyl acetate, Methyl ethyl Ketone, tetrahydrofuran Remarks: Isopropyl acetate, tetrahydrofuran and methyl ethyl Ketone are defined as “Solvents with low
toxic potential” according with ICH Q3C Guideline.
Salmeterol Xinafoate contains not less than 98,0% and not more than 102,0 % of C25H37NO4·C11H8O3 calculated with reference to the anhydrous substance.
Remarks: This product meet requirements of EP monograph Nº 022005:1765
Salmeterol
Xinafoate
Chemical Development Plan
Final of Synthesis Development
Validation of Analytic Methods
Customer File
Industrial Batches for DMF
DMF in CTD Format
Process Validation (2006)
Certificate of suitability Eur. Ph. (2006)

Source: http://www.lesvi.com/imag/eng/products/api/Salmeterol_Xinafoate.pdf