Iranian Pharmaceutical industries Iranian Pharmaceutical Industry Syndicate 2017

Iranian Pharmaceutical industries Iranian Pharmaceutical Industry Syndicate 2017

1 - Introduction 2 - What we can offer 3 - Expectations 4 - Suggestions

Iran at a Glance • Area: 1, 648, 196 sq. km (2017) • • • Population: 80, 945, 718 (2017) Population growth (annual %): 1. 13% (WB 2017 est. ) GDP (nominal - PPP): US$ 416 – 1, 357 billion (WB 2014) • GDP – per capita (nominal - PPP): $ 10173. 70 – 17949. 20 (WB 2017) Exports: $ 86 billion (2014 est. ) Imports: $ 65 billion (2014 est. ) • •

Introduction - Industry • Iran was the first country in the MENA region which established pharmaceutical industry in 1946 and legalized in 1955. • Our Vaccine Industry was established in 1920

Introduction - Industry • Currently Iran has – – 107 pharmaceutical manufacturing companies 80 API manufacturing companies 65 countrywide pharmaceutical distribution companies 101 companies specializing in the import and export of pharmaceuticals. • Quantity wise 96% of pharmaceuticals is locally produced.

Introduction – Dosage Forms • The Iranian pharmaceutical industry formulates and produces nearly 2000 items of pharmaceuticals in all prevalent forms such as: – liquid injectable (vial, PFS and Cartridge) – Solid – semi-solid – Oral Liquid – Sachet – soft gel – Lyophilized

Introduction - Market • Market Share - Domestic produced pharmaceuticals is over 65% of the total market • Market Value - In 2015 the pharmaceutical market in Iran was around 4. 2 billion USD • Employment - over 50, 000 people directly and over 200, 000 people indirectly.

Introduction- Policy • The strategies of the Iranian government with regard to pharmaceuticals are: – – Production support policies (APIs and finished products) Quality improvement Price control Appropriate supply of pharmaceuticals

Introduction - Advantages • Price – Iranian Generic Pharmaceutical Products as well as our Biosimilars are offered with competitive prices in the region • Quality – Iran is going to join the PIC/S and is implementing PIC/S guidelines – GMP issues were implemented in the majority of Industry – Iranian pharmaceutical industries can offer products with the same safety and efficacy as brands

Introduction – Hi-Tech area • In the last 2 decades Iranian pharmaceutical industry made important breakthrough in the hightech areas, such as: – Biotechnology – Nanotechnology – Chemotherapy

Introduction - Biosimilars • Iranian Biosimilar Industry: – Unique in the region – The biggest capacity in the region – The biggest basket of products – Competitive prices – Same quality as brands based on Clinical Trials

Introduction - Export • Iranian Pharmaceutical products (APIs and finished products) have been exported to over 40 countries, just to name a few: • • Russia Ukraine Syria Pakistan Azerbaijan Armenia Afghanistan Vietnam

What Iranian pharmaceutical industry can offer in post-JCPOA times • Meeting most of the pharmaceutical requirements of the region with competitive prices and same quality as existing products • Joint investment for establishment and renovation of pharmaceutical Industry • Transfer of technical, engineering, and formulation know-how

Suggestion • Establishing an official working committees in order to find best ways of cooperation • Assistance from the Iranian Pharmaceutical Regulatory and the Syndicate to launch studies to find ways of cooperation

World Development Indicators Database, World Bank 2015

Iran Population Pyramid 2015 Median Age: 28. 3

Health Status • Maternal mortality rate: 25 deaths/100, 000 live births (2015 est. ) • Infant (<1 year) mortality rate: 14 deaths/1, 000 live births (WB 2013) • Child (<5 years) mortality rate (U 5 MR): 18/1, 000 live births (UNICEF, 2012) • Life expectancy at birth m/f (years): 72/76 (WHO 2012) • Health expenditures, total (% of GDP): 6. 7% (WB 2014) • Total health expenditures per capita (Intl $): $1, 562 (WHO 2012) • Health expenditures per capita (current US$): $432 (WB 2014) • Physician density: 9 physicians/10, 000 population (104 th) • Hospital bed density: 14 beds/10, 000 population (126 th)

World Pharma Market CAGR 687 728 716 (compound annual growth rate) 4. 8% 723 743 734 772 816 872 926 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2/21/2021 Dr. K. Amjadi amjadyk@yahoo. com 987 Series 1 1000 900 800 700 600 500 400 300 200 100 0

Pharma Status in Iran (2016) 166 Finished Product Companies (106 operational) 80 API Manufacturers (50 operational) 46 National Distribution Companies 160 Pharmaceutical Trading Companies (60 operational) 15, 000 Pharmacists & 11, 500 Pharmacies National Drug Policy (NDP) incl. Generic Substitution Policy Stringent Standards & Controls on Pharmaceutical Companies; NFDCL, …

Value of Medicines Market in Iran (bn USD) (2005 to 2014), CAGR 2005 -2014 = +14. 5% 5. 0 4. 7 27% 4. 5 22% 24% 21% 23% 22% 3. 5 1. 9 2. 0 1. 5 20% 15% 12% 10% 2. 3 2. 5 8% = 14 4 01 1. 6 10% 5% R 2005 -2 CAG 30% 25% 3. 9 3. 1 2. 9 3. 0 4. 4 22% 3. 8 4. 0 4. 7 0% 1. 3 -5% 1. 0 -10% 0. 5 -15% -17% 0. 0 -20% 2005 2006 2007 2008 2009 2010 Value (bn $) 2011 2012 Growth (%) 2013 2014 2015 f

Per Capita Medicine Expenditure (USD) 2005 to 2015 70. 0 61. 6 56. 4 60. 0 51. 0 50. 0 39. 0 40. 0 50. 4 42. 2 32. 2 26. 3 30. 0 20. 0 60. 0 18. 2 22. 0 10. 0 Year 2005 Year 2006 Year 2007 Year 2008 Year 2009 Year 2010 Year 2011 Year 2012 Year 2013 Year 2014 Year 2015 f

Local production / importation ratio by volume 120% 97% 96% 96% 97% 97% 4% 3% 4% 4% 3% 3% 1379 1380 1381 1382 1383 1384 1385 1386 100% 96% 95% 97% 3% 4% 5% 3% 1387 1388 1389 1390 91% 95% 97% 98% 5% 3% 2% 1392 1393 1394 80% 60% 40% 20% 0% Imports Local Production 9% 1391 1395

Local production / importation ratio by value 100% 90% 85% 82% 80% 78% 76% 72% 70% 68% 66% 64% 60% 50% 40% 30% 20% 15% 18% 20% 22% 1381 1382 24% 28% 30% 1384 1385 32% 34% 36% 60% 40% 64% 36% 61% 63% 61% 39% 37% 39% 1391 1392 1393 66% 34% 10% 0% 1379 1380 1383 Imports Local Production 1386 1387 1388 1389 1390 1394 1395

Iran National Drug Policy key points – – – Generic medicines and generic substitution Support of local production Accessibility and affordability of essential medicines National insurance coverage of medicine in public and private sectors Quality of medicines (production, distribution and dispensing) Rational use of medicines Price control and Market regulation Herbal, supplementary and Traditional Medicines Exports of pharmaceuticals Drug information centers Pharmacovigilance program

Comparison Between Iranian Pharmaceutical Production and Imports Years 1996 -2025 9600 9200 8800 8400 8000 7600 7200 6800 6400 6000 5200 Average Value of an Imported Medicine 4800 4400 Average Value of a Medicine 4000 3600 3200 Average Value of a Locally Manufactured 2800 Medicine 2400 2000 1600 1200 800 400 Year 1404 1403 1402 1401 1400 1399 1398 1397 1396 1395 1394 1393 1392 1391 1390 1389 1388 1387 1386 1385 1384 1383 1382 1381 1380 1379 1378 1377 0 1376 Price (RLS) 5600

Consumption of therapeutic categories during 1380 (2000) to 1392 ( 2012) by ATC

CAGR of cardiovascular products during 2000 - 2011 CAGR% Average GR% Antihypertensive 23. 84% 25. 20% Antihyperlipidemic 24. 86% 33. 19% Anticoagulant 53. 36% 56. 55% Antiplatelet 69. 08% 83. 27% Antianginal 23. 17% 27. 85% To treat tachycardia 20. 79% 22. 84% To treat CHF 39. 53% 44. 80% Fibrinolytic 26. 91% 34. 99% To treat heart block/failure/arrest 21. 34% 22. 05% Diuretic 31. 38% 27. 92% Therapeutic Group

Endocrine products consumption during 2000 -2011 by volume and value 2, 500, 000 3, 000, 000 2, 500, 000, 000 2, 000, 000, 000 1, 500, 000, 000 1, 000, 000 value 1, 000, 000 500, 000 Volume 0 80 81 82 83 84 85 86 87 88 89 90

CAGR of endocrine products during 2000 -2011 by local production and importation Endocrinology CAGR%( «LP) 38. 53% Endocrinology average GR% (LP) 41. 27% Endocrinology CAGR% (IMP) 35. 38% Endocrinology average GR% (IMP) 36. 15%

CAGR of Endocrinological Products 2000 -2011 Drug Molecule SOMATROPIN. 1 TRIPTORELIN. 2 MENOTROPIN. 3 METFORMIN. 4 INSULIN. 5 FOLITROPIN. 6 GLIBENCLAMID. 7 CONJUGATED . 8 ESTROGENS CABERGULINE. 9 LEVOTHYROXIN. 10 CAGR% Average GR% 44. 03% 51. 23% 23. 02% 47. 92% 43. 81% 91. 95% 24. 30% 11. 11% 46. 17% 68. 56% 25. 31% 50. 06% 46. 98% 156. 42% 27. 92% 12. 69% 161. 81% 35. 32% 2746. 93% 40. 36%

Fast growing anticancer consumption during 2000 -2011 4, 000, 000 3, 500, 000, 000 3, 000, 000 2, 500, 000, 000 2, 000, 000 1, 500, 000, 000 1, 000, 000 500, 000, 000 0 80 81 82 83 84 85 86 87 88 89 90

EXPORT STATISTIC Manufacturer Name Exir IRAN HORMONE IRAN HORMONE Sobhan Darou Sobhan Darou Sobhan Darou Sina darou Laboratories Aburaihan Pharmaceutical Co Aburaihan Pharmaceutical Co Caspian Tamin Caspian Tamin Nano. Alvand Cinna. Gen Zahravi Pharmaceutical Co. Alborz Darou Pakhsh Pharmaceutical Mfg Co. Generic Name Protamin Sulphate Prednisolone 5 mg Methimazole 5 mg Vitamin B 6 40 mg Levonorgestrel 1. 5 mg Letrozole 2. 5 mg Oxymetholone 50 mg Clonazepam 1 Clonazepam 2 Pramipexole. 18 Pramipexole. 7 Haloperidol(drop) Nortriptyline 25 Aripiperazole 10 Aripiperazole 15 Clonazepam 1 Clonazepam 2 Desmopressin Acetate (10 mcg/dose) Calcitonin Salmon 50 IU Amp. Octerotide 50 mcg/1 ml Amp. Letrozole 2. 5 mg Tab. Nandrolone Decanoate 100 mg/1 ml Amp. Hydroxy Progesterone Caproate Amp Vitamin D 3 300, 000 U/ml Inj. Heparin 25000 U/5 ml Vial Oxytocin 10 U/1 ml Inj. Tranexamic Acid 500 mg/5 ml Inj. FENTANYLE CITRATE 50 MCG/10 ML PETHEDIN 100 Alvotere 80 mg Cinna. Poietin 4 K Tacrolimus 1 mg Cyclosporine 25 mg Cyclosporine 50 mg Cyclosporine 100 mg Clonazepam 2 mg METOPROLOL TARTRATE 5 mg / 5 ml (Mycophenolate Mofetil) vitamin D 3 (300000 U) Morphine Sulfate HCG 5000 H. M. G. (Menotropin) Brand Name Hepadote Nisopred Longil Letrofem Clonazepam-Sobhan 1 Clonazepam- Sobhan 2 Sopexol®. 18 Sopexol®. 7 Haloperidol Nortriptyline 25 Abilizol 10 Abilizol 15 Clonazepam-Sobhan 1 Clonazepam- Sobhan 2 Desmex® Mianin® Letrax® 2. 5 Femolife® DITHRECOL® HEPARODIC® 25000 OXYTIP® 10 TRANEXIP® ــ Docetaxel 80 mg Erythropoietin 4000 IU Cograft Iminoral _ _ METORAL Cytocept® Total Form of the product Exported Country Vial Syria TABLET SYRIA TABLET SYRIA SCORED TABLET SYRIA ORAL DROP SYRIA SCORED TABLET SYRIA TABLET SYRIA Nasal Spray Syria AMPOULE Syria Tab Syria AMPOULE Syria Ampoule Syria Vial Syria Ampoule Syria Vial Syria PFS Syria Capsule Syria Tablet Syria AMP SYRIA Tablet Syria AMPOULE Syria Agent Name Mehravaran Salamat Persia Mehravaran Salamat Persia Baraka Group Baraka Group Baraka Group Noavaran Salamat Razi Otwo Medical Co Otwo Medical Co Bassma Medical GFTO _ O-Two Medical O-Two Medical NOAVARAN SALAMAT RAZI Otomedical Otomedical ﺟﻤﻊ کﻞ ﻓﺮﻭﺵ ﺑﻪ کﺸﻮﺭ 8, 467 16, 934 34, 366 72944 2, 890 14, 626 8, 073 6, 771 15, 297 25, 037 281, 289 $ 205, 787. 70 $ 1, 564, 736. 62 2, 376, 669 6, 062 353, 296 20, 000 4, 282 8, 736 22, 500 5. 048. 765

ﻧﺎﻡ ﺷﺮکﺖ ﻧﺎﻡ کﺸﻮﺭ ﺗﺎﺭیﺦ ﺛﺒﺖ ﺷﺮکﺖ ﺗﺎﺭیﺦ ﻧﺎﻡ ﻣﺤﺼﻮﻻﺕ ﺛﺒﺖ ﻓﺮﻡ ﺍﻧﻘﻀﺎی ﺷﺪﻩ ﻣﺤﺼﻮﻝ ﺛﺒﺖ Exir Company Registration in MOH of Syria (GMP) Exir Syria 2. 2009 Sina Daru Syria ﺍﺳﺖ ﻧﺸﺪﻩ ﺛﺒﺖ _ ﺷﺮکﺖ _ /// _ Ampoule Desmex Nasal Spray Vitamin D 3 (Colecalciferol) 300, 000 Iu Amp Nitroglycerin 5 mg/Ml 2 ml Amp Testostrone Enantate 250 mg/1 ml Amp Cisatracurium As Besilate 2 mg/Ml 5 ml Amp Succinylcholine Chloride 50 mg/Ml 10 ml Amp Clindamycin As Phosphate 600 mg/4 ml Amp Vitamin B 1/B 6/B 12 Amp Heparin Sodium 25, 000 Iu /5 ml Vial Vitamin B 12 1000 mcg/1 ml Amp Nano. Alvand Aryo. Seven Altebrel 25 Altebrel 50 Zytux 100 Zytux 500 Aryo. Trust 150 Aryo. Trust 440 - Caspian Tamin Syria /// Nano. Alvand Cinna. Gen Aryo. Gen Nano. Hayat Syria Syria Syria Syria Cinna. Gen Cinno. Vex Reci. Gen 44 Aryo. Gen Zist Darou Nano. Hayat - Vial PFS PFS Vial - Zahravi Pharmaceutical Co. Syria Cyclosporine Softgel _ Capsules Aburaihan Pharmaceutical Co. Syria --- Vetastrol Oestradiol® Vial Benoate 2 mg/ml 2017/47 Clotin® Heparin 5000 IU/1 ml Amp. 6/9/20 Alborz Darou Syria ﺛﺒﺖ ﺣﺎﻝ ﺩﺭ METOPROLOL TARTRATE 5 mg / 5 ml Alborz Darou Syria ﺛﺒﺖ ﺣﺎﻝ ﺩﺭ LEVODOPA-C FORTE 250 mg Alborz Darou Syria ﺛﺒﺖ ﺣﺎﻝ ﺩﺭ LEVODOPA-C 110 mg - REGISTRATION ﻓﺮﻡ ﻣﺤﺼ ﻮﻝ ﻣﺤﺼﻮﻻﺕ ﺩﺭ ﺣﺎﻝ ﺛﺒﺖ ﻧﺎﻡ ﻧﻤﺎیﻨﺪﻩ ﻋﺒﺪﺍﻟﻤﻠکی آﻘﺎی ﻃﺐ ﺳﻮﺭﻧﺎ ﺷﺮکﺖ Nasal Spray ﺭﺍﺯی ﺳﻼﻣﺖ ﻧﻮآﻮﺭﺍﻥ ﺑﺎﺳﻤﺎ ﺷﺮکﺖ - - Otwo Medical Ampo --ule AMPO Bareakat ULE TABLE Bareakat T

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