The sales of pharmaceuticals (imported + locally produced) in the course of last Iranian year (year 1386 = 20 March 2007 to 21 March 2008) totalled to 19,235,027,000,000 Iranian Rials equal to 2,019,425,000 US$ (at exchange rate of 1 US$ = 9,525 Iranian Rials.
The share of imported products in this year was 36% of the total sales, and 64% was accounted to the local production.
Wednesday, August 20, 2008
Tuesday, August 19, 2008
Top selling products - value
The 10 to selling products (value wise) during the last Iranian year were as follows:
1-TIENAM® 500MG VIAL
2-TAXOTERE® 80MG 2ML VIAL
3-BETAFERON® 8MIU VIAL
4-REBIF® 44MCG/0.5ML SYRINGE
5-CEFTRAX® 1G VIAL
6-NORDITROPIN® 4U VIAL
7-CELLCEPT® 500MG TAB
8-GEMZAR® 1G VIAL
9-DIPHERELINE® 3.75MG VIAL
10-COSAR-AMOXICILLIN® 500MG CAP
1-TIENAM® 500MG VIAL
2-TAXOTERE® 80MG 2ML VIAL
3-BETAFERON® 8MIU VIAL
4-REBIF® 44MCG/0.5ML SYRINGE
5-CEFTRAX® 1G VIAL
6-NORDITROPIN® 4U VIAL
7-CELLCEPT® 500MG TAB
8-GEMZAR® 1G VIAL
9-DIPHERELINE® 3.75MG VIAL
10-COSAR-AMOXICILLIN® 500MG CAP
Sunday, August 17, 2008
Top selling products - quanity
10 top selling product (quantity wise) during the last Iranian year were as follows:
1-DIPHNOKIM® 2.5MG TAB
2-RANITIDINE 150MG TAB
3-ADULT COLD TAB
4-FERIRON® TAB
5-ADULT COLD TAB
6-ASA 80MG EC TAB
7-COSAR-AMOXICILLIN® 500MG CAP
8-ATENOLOL 50MG TAB
9-DIPHENOXYLATE 2.5MG TAB
10-ANTIHISTAMINE DECONGESTANT TAB
1-DIPHNOKIM® 2.5MG TAB
2-RANITIDINE 150MG TAB
3-ADULT COLD TAB
4-FERIRON® TAB
5-ADULT COLD TAB
6-ASA 80MG EC TAB
7-COSAR-AMOXICILLIN® 500MG CAP
8-ATENOLOL 50MG TAB
9-DIPHENOXYLATE 2.5MG TAB
10-ANTIHISTAMINE DECONGESTANT TAB
Saturday, August 16, 2008
Registration of Pharmaceutical Products in Iran
Documents required for registration of a pharmaceutical product in Iran after its addition to Iranian list of formulary
I- Certificate of Pharmaceutical Product according the specification of WHO
I I-A certificate/letter containing list of the countries where product (in any dosage form) is registered and their registration number
I II-A certificate/letter containing list and of the countries where product (any dosage form) is sold/used, and information regarding date of introduction in these markets.
IV-A certificate/letter has a factory/manufacturing unit in them and the address of factory containing list of the countries in which the company
V-Letter of agency for the product(s) to an Iranian company
VI-Complete form for price of product
VII-Complete Drug Importing Application
VIII-Samples of product including CoA and all analytical records
plus a comprehensive file (DMF = Drug Master File) containing following documents:
1-Company Profile
Including also (not limited to ) plant master file including also the machinery, and equipments used for production and analysis of the product.
2- Manufacturer
-Manufacturing authorization holder (name, address, country)
-Number and date of the first marketing authorization/renewal
-Manufacturer of finished product (name, address, country)
-Flow-chart indication the different sites involved in the manufacturing process, packaging and release of the medicinal product.
-Manufacturer of the active substance(s) (Name, address and country)
3-Formula/composition of the product
-Quantitative and qualitative composition in terms of the active substance(s)
-List of active substances separately form the excipient(s)
(Name of active substance (INN), name of excipients, function, quantity, unit, reference/pharmacopoeia)
-Incompatibilities of the excipients
-List of materials of animal and/or human origin contained or used in the manufacturing process of the medicinal product
-List of constitutes from other origins
-Coloring, flavoring and perfume compounds
4-Compostion of batch
-Complete composition of a trial batch
-Complete composition of batch for production at industrial level
S-Packaging material of the product
1-specification
2-method of analysis
3-certificate of analysis
* 4-Samples of packaging material
6-Method of Preparation
a-manufacturing formula
b-manufacturing process*
c-manufacturing equipments
7-Control of starting materials
a-active ingredients
1-specifications
2-method of analysis
3-potential impurities and determination
4-certificate of analysis*
b-other ingredients
1-specification
2-method of analysis
4-certificate of analysis*
5-the non-active substances not-remaining in the finished product
8-Control tests on finished products
a-specification
b-batch analysis
c-certificate of analysis*
d-the non-active substances remaining in the finished product
e-the limitation for the potentially toxic substance(s) which may remain in the finished product and the method for their determination.
9-Sampling
-Method of sampling
-Details of sampling plan
-Method of selection of samples for analysis
-Method of increasing or decreasing the number of samples
-Deviations and necessary actions needed to be taken based on statistical methods.
10-ln-process controls
-Details of physical, chemical, microbiological and other tests during the process of production
-Deviations in in-process tests and actions needed to be taken
-Statistical methods for combination of the result of tests on consecutive batches
-Method of analysis of in-process control as a feed-back for improving/adopting the production process
11-Pharmacopial specification of the product
-Acceptable range of physical, chemical, microbiological and other tests based on the relevant pharmacopeias
-Conformity of the product with specification of the pharmacopeias
-Pharmacopeias tests for guaranteeing the clinical, physical, chemical, microbiological characteristics of the product in the course of its shelf-life
-Comparisons/conformity of the release characteristics of the product
-Additional test compared to pharmacopeias specifications.
-Alternative tests to pharmacopeias tests
12-Stability
a-controlled batches
b-storage conditions
c-description of containers
d-analytical methods
e-stability schedule
f-results*
g-interpretation of results h-shelf life*
i-validation of stability tests
13-Pharmacology and Toxicology report
14-Clinical trials
15-Bioequivalency, and pharmacodynamics
16-Patient information leaflet
17 -Labels and outer carton text
1S-Samples of the product with original certificate of analysis plus the required reference standard for testing the samples
N.B:
-Documents "I" to "V" in above need to be original copy and need to be legalized by Iranian Embassy.
-Documents marked as "*" within the above list of "1" to "18" need to be an original copy and signed and stamped by the responsible person in the factory/company.
Number of samples required. Samples: -Large volume parenterals
-Small volume parenterals 1 and 2 cc -Small volume parenterals 5 to 10 cc -Drop, sterile ointment
-Oral solutions, syrups, suspensions -Topical ointment, cream, spray -Shampoo
-Tablets and capsules
-Soaps
-Suppositories
-Injectable vials
20 200 100
60 20 20 15
200
10 50 50
I- Certificate of Pharmaceutical Product according the specification of WHO
I I-A certificate/letter containing list of the countries where product (in any dosage form) is registered and their registration number
I II-A certificate/letter containing list and of the countries where product (any dosage form) is sold/used, and information regarding date of introduction in these markets.
IV-A certificate/letter has a factory/manufacturing unit in them and the address of factory containing list of the countries in which the company
V-Letter of agency for the product(s) to an Iranian company
VI-Complete form for price of product
VII-Complete Drug Importing Application
VIII-Samples of product including CoA and all analytical records
plus a comprehensive file (DMF = Drug Master File) containing following documents:
1-Company Profile
Including also (not limited to ) plant master file including also the machinery, and equipments used for production and analysis of the product.
2- Manufacturer
-Manufacturing authorization holder (name, address, country)
-Number and date of the first marketing authorization/renewal
-Manufacturer of finished product (name, address, country)
-Flow-chart indication the different sites involved in the manufacturing process, packaging and release of the medicinal product.
-Manufacturer of the active substance(s) (Name, address and country)
3-Formula/composition of the product
-Quantitative and qualitative composition in terms of the active substance(s)
-List of active substances separately form the excipient(s)
(Name of active substance (INN), name of excipients, function, quantity, unit, reference/pharmacopoeia)
-Incompatibilities of the excipients
-List of materials of animal and/or human origin contained or used in the manufacturing process of the medicinal product
-List of constitutes from other origins
-Coloring, flavoring and perfume compounds
4-Compostion of batch
-Complete composition of a trial batch
-Complete composition of batch for production at industrial level
S-Packaging material of the product
1-specification
2-method of analysis
3-certificate of analysis
* 4-Samples of packaging material
6-Method of Preparation
a-manufacturing formula
b-manufacturing process*
c-manufacturing equipments
7-Control of starting materials
a-active ingredients
1-specifications
2-method of analysis
3-potential impurities and determination
4-certificate of analysis*
b-other ingredients
1-specification
2-method of analysis
4-certificate of analysis*
5-the non-active substances not-remaining in the finished product
8-Control tests on finished products
a-specification
b-batch analysis
c-certificate of analysis*
d-the non-active substances remaining in the finished product
e-the limitation for the potentially toxic substance(s) which may remain in the finished product and the method for their determination.
9-Sampling
-Method of sampling
-Details of sampling plan
-Method of selection of samples for analysis
-Method of increasing or decreasing the number of samples
-Deviations and necessary actions needed to be taken based on statistical methods.
10-ln-process controls
-Details of physical, chemical, microbiological and other tests during the process of production
-Deviations in in-process tests and actions needed to be taken
-Statistical methods for combination of the result of tests on consecutive batches
-Method of analysis of in-process control as a feed-back for improving/adopting the production process
11-Pharmacopial specification of the product
-Acceptable range of physical, chemical, microbiological and other tests based on the relevant pharmacopeias
-Conformity of the product with specification of the pharmacopeias
-Pharmacopeias tests for guaranteeing the clinical, physical, chemical, microbiological characteristics of the product in the course of its shelf-life
-Comparisons/conformity of the release characteristics of the product
-Additional test compared to pharmacopeias specifications.
-Alternative tests to pharmacopeias tests
12-Stability
a-controlled batches
b-storage conditions
c-description of containers
d-analytical methods
e-stability schedule
f-results*
g-interpretation of results h-shelf life*
i-validation of stability tests
13-Pharmacology and Toxicology report
14-Clinical trials
15-Bioequivalency, and pharmacodynamics
16-Patient information leaflet
17 -Labels and outer carton text
1S-Samples of the product with original certificate of analysis plus the required reference standard for testing the samples
N.B:
-Documents "I" to "V" in above need to be original copy and need to be legalized by Iranian Embassy.
-Documents marked as "*" within the above list of "1" to "18" need to be an original copy and signed and stamped by the responsible person in the factory/company.
Number of samples required. Samples: -Large volume parenterals
-Small volume parenterals 1 and 2 cc -Small volume parenterals 5 to 10 cc -Drop, sterile ointment
-Oral solutions, syrups, suspensions -Topical ointment, cream, spray -Shampoo
-Tablets and capsules
-Soaps
-Suppositories
-Injectable vials
20 200 100
60 20 20 15
200
10 50 50
Tuesday, August 12, 2008
Salary Range of Multinational Pharmaceutical Companies in Iran
The below are the monthly salary range for employees with Pharm.D. or M.D. degree:
- Medical Representative: 1,000 to 1,700 US$
- Supervisor and Product Manager: 1,800 to 3,000 US$
- Sales Manager and Marketing Manager: 3,000 to 5,000 US$
- Country Manager: 5,000 to 10,000 US$
Monday, August 11, 2008
Pricing , Mark ups
The average mark-up for pharmaceuticals in Iran are as follows:
Custom Tax: 4% (for products not locally produced) and 65% ( for products which are locally produced)
Clearance/etc. expenses:4%
Importers profit: 13%
Distributors profit: 10%
Pharmacy shop profit: 15%
Custom Tax: 4% (for products not locally produced) and 65% ( for products which are locally produced)
Clearance/etc. expenses:4%
Importers profit: 13%
Distributors profit: 10%
Pharmacy shop profit: 15%
Sunday, August 10, 2008
Leading Importers
10 leading importers in last Iranian year were as follows:
1-Cobel Darou
2-Shafayab Goster
3-Jahan Behbood
4-Akbarieh
5-Behestan Darou
6-Tejarat and Sanat Group
7-KBC
8-Poura-Teb
9-Kamal Darou
10-Nedayeh Mahya
1-Cobel Darou
2-Shafayab Goster
3-Jahan Behbood
4-Akbarieh
5-Behestan Darou
6-Tejarat and Sanat Group
7-KBC
8-Poura-Teb
9-Kamal Darou
10-Nedayeh Mahya
Saturday, August 9, 2008
Leading Distributors
10 leading distributors in last Iranian year:
1-Darou Pakhsh
2-Pakhsh Razi
3-Pakhsh Hedjrat
4-Pakhsh Ferdous
5-Pakhsh Alborz
6-Pakhsh Ghasem
7-Darou Gostar Razi
8-Darou Behdasht Shafa Arad
9-Armaghan Darou
10-Mahya Darou
1-Darou Pakhsh
2-Pakhsh Razi
3-Pakhsh Hedjrat
4-Pakhsh Ferdous
5-Pakhsh Alborz
6-Pakhsh Ghasem
7-Darou Gostar Razi
8-Darou Behdasht Shafa Arad
9-Armaghan Darou
10-Mahya Darou
Wednesday, August 6, 2008
Leading Manufacturers
Iranian leading manufacturers are as follows:
1-Darou Pakhsh
2-Farabi
3-Exir
4-Jaber Ebn Hayan
5-Alborz Darou
6-Kosar
7-Tehran Shimi
8-Zahravi
9-Sina Darou
10-Sobhan Darou
1-Darou Pakhsh
2-Farabi
3-Exir
4-Jaber Ebn Hayan
5-Alborz Darou
6-Kosar
7-Tehran Shimi
8-Zahravi
9-Sina Darou
10-Sobhan Darou
Friday, August 1, 2008
Pharmacy Schools in Iran
Tehran Univeristy of Medical Sciences and Health Services
School of Pharmacy
Enghelab Square, 16 Azar Street, Tehran University, Faculty of Pharmacy
P.O.Box: 14155 - 6451, Tehran, Iran
Tel:+98 21 66959090-8
E.Mail: pharmacy@sina.tums.ac.ir
URL: http://pharmacy.tums.ac.ir/fa/home/Default.aspx
--------------------------------------------------------------------------------
Shahid Beheshti University of Medical Sciences and Health Services
School of Pharmacy
No 105, Shams Alley, Across from Tavaneer Ave., Vali-E-Asr Ave
P.O. Box: 14155 - 6153, Tehran
Tel: +98 21 8773523
Fax: +98 21 8795008
Email: pharmacy@morva.net
URL: http://pharmacy.morva.net/
--------------------------------------------------------------------------------
Shiraz University of Medical Sciences - Pharmacy School
P.O. Box: 71345-1849
Shiraz
Tel: +98
Fax: +98
Email: meddean@sums.ac.ir
URL: www.sums.ac.ir/
--------------------------------------------------------------------------------
Tabriz University of Medical Sciences - School of Pharmacy
Tabriz 21664
Tel: +98 411 334 1315
Fax: +98 411 334 4798
Email: GarjaniA@tbzmed.ac.ir
URL: www.tbzmed.ac.ir
School of Pharmacy
Enghelab Square, 16 Azar Street, Tehran University, Faculty of Pharmacy
P.O.Box: 14155 - 6451, Tehran, Iran
Tel:+98 21 66959090-8
E.Mail: pharmacy@sina.tums.ac.ir
URL: http://pharmacy.tums.ac.ir/fa/home/Default.aspx
--------------------------------------------------------------------------------
Shahid Beheshti University of Medical Sciences and Health Services
School of Pharmacy
No 105, Shams Alley, Across from Tavaneer Ave., Vali-E-Asr Ave
P.O. Box: 14155 - 6153, Tehran
Tel: +98 21 8773523
Fax: +98 21 8795008
Email: pharmacy@morva.net
URL: http://pharmacy.morva.net/
--------------------------------------------------------------------------------
Shiraz University of Medical Sciences - Pharmacy School
P.O. Box: 71345-1849
Shiraz
Tel: +98
Fax: +98
Email: meddean@sums.ac.ir
URL: www.sums.ac.ir/
--------------------------------------------------------------------------------
Tabriz University of Medical Sciences - School of Pharmacy
Tabriz 21664
Tel: +98 411 334 1315
Fax: +98 411 334 4798
Email: GarjaniA@tbzmed.ac.ir
URL: www.tbzmed.ac.ir
Monday, July 21, 2008
Razi Father of Pharmcay in Iran
Abū Bakr Muhammad ibn Zakariyā Rāzī (Arabic: أبو بكر محمد بن زكريا الرازي, Persian: زكريای رازی Zakariā-ye Rāzi; Latin: Rhazes or Rasis) was a Persian, chemist, physician, philosopher and scholar. According to Biruni, Razi was born in Rayy, Iran in the year 865 (251 AH) and died there in 925 (313 AH).
Razi made fundamental and enduring contributions to the fields of medicine, alchemy, and philosophy, recorded in over 184 books and articles in various fields of science. He was well-versed in Persian, Greek and Indian medical knowledge and made numerous advances in medicine through own observations and discoveries. He was an early proponent of experimental medicine and is considered the father of pediatrics. He was also a pioneer of neurosurgery and ophthalmology.
As an alchemist, Razi is known for his study of sulfuric acid. He also discovered ethanol and refined its use in medicine.
Razi was a rationalist, and was very confident in the power of reason; he was widely regarded by his contemporaries and biographers as liberal and free from any kind of prejudice, very bold and daring in expressing his ideas without a qualm.
He traveled extensively and rendered service to several princes and rulers, especially in Baghdad, where his laboratory was located. As a teacher in medicine, he attracted students of all disciplines and was said to be compassionate and devoted to the service of his patients, whether rich or poor.
The modern-day Razi Institute in Tehran, and Razi University in Kermanshah were named after him, and 'Razi Day' ('Pharmacy Day') is commemorated in Iran every August 27.
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