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Arshack Chimie Ltd.

Unit 16,4th Floor, No. 6, 3rd St.,


Vozara Ave, Tehran-Iran
Tel: +98 21 88703080-81 WWW.ARSHACK.COM
Fax: +98 21 88713881
E-mail: info@arshack.com

Iopamidol

Registered strengths: 612 mg/mL (eq. to 300 mgI/mL) & 755 mg/mL (eq. to 370 mgI/mL)

Imported and Local Brands /Generics

Product Name Market


No. Holder/Manufacturer Considerations
/ Brand Status
Under
1 ISOVUE® Beracco Diagnostics registration
The new products and has not been entered to.
®
2 SCANLUX Sanochemia Registered The new products and has not been entered to.

This table shows the total market size (Retail price in pharmacies) for ISOVUE® injections from March
2007 to March 2008.
(Import) Market Size March 2007 to March 2008
Product Dosage Retail
Strength (Retail price basis)
Name form price/unit
No of Units $
-------------- ------------ ----------- ---------- ---------- ----------
-------------- ------------ ----------- ---------- ---------- ----------
This table shows the total market size (Retail price in pharmacies) for SCANLUX® injections from
March 2007 to March 2008.
(Import) Market Size March 2007 to March 2008
Product Dosage Retail
Strength (Retail price basis)
Name form price/unit
No of Units $
-------------- ------------ ----------- ---------- ---------- ----------
-------------- ------------ ----------- ---------- ---------- ----------
Mark-up calculation

Description % % % % Factor
FOB Price 1.00000
Insurance & Freight 5.00% 0.05000
C I F Price 1.05000
Import Duty & Custom Clearance* 5.00% 0.05250
Agent Cost of Goods (COG) 1.10250
Gross Mark-up 15.0% 0.16538
Final Quoted Price to Importer 1.26788
Importer Mark-up 15.0% 0.19018
Importer Selling Price 1.45806
Distributor Mark-up 12.0% 0.17497
Distributor Selling Price % 1.63302
Retailer Mark-up 20.0% 0.32660
Retail Selling Price % 1.95963
Arshack Chimie Ltd.
Unit 16,4th Floor, No. 6, 3rd St.,
Vozara Ave, Tehran-Iran
Tel: +98 21 88703080-81 WWW.ARSHACK.COM
Fax: +98 21 88713881
E-mail: info@arshack.com

Trends and Forecasts:

1. The product is new to the market.


2. There is not local manufacturer for this product.
3. There is a good capacity for entrance of a local product.

Regulatory requirements for registration of API:

1. Authorization letter or exclusive agent agreement for registration, sales, marketing and import of API
to Iran under exclusive base.

2. Copy of GMP certificate of manufacturer or holder

3. Site Master File (SMF) of manufacturer or holder

4. Open part section of DMF

5. Sample with working standard and related impurities

Timeline to get approval:

Since we are technically supported by well-known Swiss company "Inter Pharmaco Swiss" and they will
insert your name as approved API supplier in dossiers, the registration of API source will be shorter
than regular time and it is anticipated about 6 months.