Market Analysis For Iopamidol
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Arshack Chimie Ltd. Unit 16,4th Floor, No. 6, 3rd St., Vozara Ave, Tehran-Iran Tel: +98 21 88703080-81 Fax: +98 21 88713881 E-mail: [email protected]
WWW.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 No.
Product Name / Brand
Holder/Manufacturer
1
ISOVUE®
Beracco Diagnostics
2
®
SCANLUX
Sanochemia
Market Status
Considerations
Under registration Registered
The new products and has not been entered to. 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. Product Name
Strength
---------------------------
Dosage form
------------ ---------------------- -----------
Retail price/unit
(Import) Market Size March 2007 to March 2008 (Retail price basis)
-------------------
No of Units
$
-------------------
-------------------
This table shows the total market size (Retail price in pharmacies) for SCANLUX® injections from March 2007 to March 2008. Product Name
Strength
---------------------------
Dosage form
------------ ---------------------- -----------
Retail price/unit
(Import) Market Size March 2007 to March 2008 (Retail price basis)
-------------------
No of Units
$
-------------------
-------------------
Mark-up calculation Description FOB Price Insurance & Freight C I F Price Import Duty & Custom Clearance* Agent Cost of Goods (COG) Gross Mark-up Final Quoted Price to Importer Importer Mark-up Importer Selling Price Distributor Mark-up
%
%
%
%
Factor
12.0%
1.00000 0.05000 1.05000 0.05250 1.10250 0.16538 1.26788 0.19018 1.45806 0.17497
%
1.63302
Retailer Mark-up
20.0%
0.32660
Retail Selling Price
%
1.95963
Distributor Selling Price
5.00% 5.00% 15.0% 15.0%
Arshack Chimie Ltd. Unit 16,4th Floor, No. 6, 3rd St., Vozara Ave, Tehran-Iran Tel: +98 21 88703080-81 Fax: +98 21 88713881 E-mail: [email protected]
WWW.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.
WWW.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 No.
Product Name / Brand
Holder/Manufacturer
1
ISOVUE®
Beracco Diagnostics
2
®
SCANLUX
Sanochemia
Market Status
Considerations
Under registration Registered
The new products and has not been entered to. 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. Product Name
Strength
---------------------------
Dosage form
------------ ---------------------- -----------
Retail price/unit
(Import) Market Size March 2007 to March 2008 (Retail price basis)
-------------------
No of Units
$
-------------------
-------------------
This table shows the total market size (Retail price in pharmacies) for SCANLUX® injections from March 2007 to March 2008. Product Name
Strength
---------------------------
Dosage form
------------ ---------------------- -----------
Retail price/unit
(Import) Market Size March 2007 to March 2008 (Retail price basis)
-------------------
No of Units
$
-------------------
-------------------
Mark-up calculation Description FOB Price Insurance & Freight C I F Price Import Duty & Custom Clearance* Agent Cost of Goods (COG) Gross Mark-up Final Quoted Price to Importer Importer Mark-up Importer Selling Price Distributor Mark-up
%
%
%
%
Factor
12.0%
1.00000 0.05000 1.05000 0.05250 1.10250 0.16538 1.26788 0.19018 1.45806 0.17497
%
1.63302
Retailer Mark-up
20.0%
0.32660
Retail Selling Price
%
1.95963
Distributor Selling Price
5.00% 5.00% 15.0% 15.0%
Arshack Chimie Ltd. Unit 16,4th Floor, No. 6, 3rd St., Vozara Ave, Tehran-Iran Tel: +98 21 88703080-81 Fax: +98 21 88713881 E-mail: [email protected]
WWW.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.
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