Pooyesh Darou Biopharmaceutical Company

• Founded in 1998 as the first knowledge based biopharmaceutical company in Iran• Collaboration with the leaders in biotechnology the International Center of Genetic E

engineering and Biotechnology (ICGEB) in Trieste, Italy and Pharmaceutical Biotechnology department, Tehran University of Medical Sciences

• Collaboration and Clinical studies in Medical School, Tehran University of Medical Sciences, Iran

Qualification Numbers

PhD and specialists 12

Pharm D. and M.D 15

Graduate (MSc.) 40

Under Graduate (BSc.) 60

Diploma and others 110

Total 237

OurStaff

Facilities

5

API Production Units• Unit A & B: 750 m2 each for productionandpurification ofrecombinantproteinsfrombacteria.

• Unit C:600 m2 forproductionandpurification ofrecombinantproteinsfrommammalian cells.

• Unit D: [futureexpansion 2016]: 400m2forindustrialfermentationwithcapacityof2000L/batch.

• Unit E: [futureexpansion2017]:500m2forproductionandpurificationofrecombinantproteinsfromCHO.

FinishedProduct Lines

Line Dosageform Capacity/yearA Vial- liquids 30,000,000

Vial- lyophilizedpowder 10,000,000B(2016) Cartridge 20,000,000C Prefilledsyringe(PFS) 30,000,000D Ampule 40,000,000E(2016) Powder 10,000,000

DivisionA

DivisionB[futureexpansion2017]Line Dosageform Capacity/yearA PFS 40,000,000B PFS 40,000,000C Vial-liquids 40,000,000

WatertreatmentSystem

8

Typeof water Capacity

Purifiedwater(PW) 3500L/hr

Water forinjection(WFI)

1170 L/hr

Puresteam(PS) 1200L/hr

• Christ (Germany)• Capacities:

• Storage tank PW 5000 L• Storage tank WFI 3500 L

• Bausch + Strobel (Germany)• 12,000 PFS/hr• 5 injectors

9

PrefilledSyringesFilling

FreezeDryer

• Two freeze dryers• Total drying area: 22 m2

• Total Capacity: 80,000 Vial 2R• Total Ice Condenser capacity: 300 kg

10

VialFilling

11

• Bausch + Strobel• 12,000 Vials/hr• Vial washing• Sterilization Tunnel

• Bausch & Strobel• Capacity: 18,000 Amp/hr• 6 injectors

12

AmpouleFilling

13

Labeling

• Labeling for ampoule & vial :Capacity 9000 containers/hr

• Labeling & plungering PFS:Capacity 6000 syr/hr

• 6 Cold rooms 2-8 °C• Total capacity about 450 m3

14

Refrigerators

Ourproducts

❖ PDcera® Pegerythropoietin (100μg,200μg/0.3ml),2016

❖ PDlasta® PegFilgrastim (6mg/0.6ml), 2015

❖ Pegaferon® Peginterferon alfa-2a(180μg/0.5ml), 2007

❖ PDgrastim® Filgrastim (G-CSF)(300μg/0.5ml),2002

APIandFinishedProducts

❖ PDferon® Interferonalfa-2b(3MIU,5MIU/ml),2000

❖ PDpoetin®Erythropoietin alfa (2000IU,4000IU,10000,20000,40000IU/0.5ml),2004

❖ PDgrowth® Somatropin (4IU/ml),2013TechnologyTransferfromArgentina2015

v PDHoMoG® HumanMenopausalGonadotrophin (75IU/ml)

Germany

v PDpreg® HumanChorionicGonadotropin(5000IU/ml)

Germany

v PDxane® Enoxaparin Sodium (2000IU/0.2ml,4000IU/0.4ml,6000IU/0.6ml,8000IU/0.8ml)

China

v Microrelin® Triptorelin (3.75mg/2ml) Italy

FinishedProducts

0

1,250,000

2,500,000

3,750,000

5,000,000

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

PDferon ® / Interferon alfa-2b

Pegaferon ® / Peginterferon alfa-2a

PDgrastim ® / Filgrastim (G-CSF) 300μg

PDpoetin ® / Erythropoietin (4000IU equivalent)

APIProductionVolume

RegisteredCountriesforPooyesh Darou Products

• Pakistan• Syria• Iraq• Azerbaijan

UnderRegistration• Russia• Algeria• Belarus

BD Hypak™ for BiotechGlass PrefillableSyringe

PrefilledSyringes(PFS)InPooyeshDarouBiopharmaceutical Co.weareusing“BDHypak™forBiotech” forourfinishedproductswhichisspecificallyoptimizedforbiotechdrugs,addressingkeyfactorsofcompatibilitywithdrugandsecondaryactivepackaging.

BDHypak™forBiotechprovides:² Increasedpatientconvenience assurancethroughoptimized

container/device integration² Reducednumberofcosmeticdefects² Reduce riskofcontainer/sensitivedruginteractions

JustReleased

ComingSoon

PipelineResearch&Development

• Exenatide• Triptorelin 11.25mgand22.5mg• Interferonbeta-1a• Pegylated Interferonbeta-1a

MarketAnalysis• Newgeneration Insulins• MonoclonalAntibodies

Ourpartners

Oursistercompanies

Contactus:ZoeT.YazdiPharm.D,MSc.,RPh.InternationalAffairsManagerPooyeshDarouBiopharmaceuticalCo.internationalaffairs@pooyeshdarou.comzoe.yazdi@gmail.comTele:+98-912-2030053Address:No13,5th st,Fatemi Ave,Tehran,Iran