December Dr. Abidi Pharmaceuticals

Transcription

1 December 2016 Dr. Abidi Pharmaceuticals

2 Abidi Evolution & Development in the past 70 years 1946 Established the First Private Pharmaceutical Company in Iran 1958 Received First License of Drug Manufacturing (Vermicide) 1961 Established a New Modern Pharmaceutical Company 1973 Established Abidi Pharmaceuticals the in the Current Site 2008 Received the first GMP Certificate for Export 2008 Production Facility upgrade 2009 Received Accredited Laboratory Certificate 2009 Manufacturing Under License Products 2015 IMS Certificate 2

3 Abidi, A leading Company in Iran Pharmaceutical Market E-2016 Rank in Volume 4 th 4 th 4 th 1 st 1 st 2 st 1 st 1 st Vol. Growth (Abidi vs. Local Market) 6% vs. 7% 12% vs. -2% 7% vs. 14% 18% vs. -3% 0.7% vs. 0.1% 1% vs. 21% 6% vs. -12% 1% vs. 6% Rank in Value 17 th 14 th 15 th 9 th 4 th 3 rd 2 nd 1 st Value Growth (Abidi vs. Local market) 24% vs. 30% 22% vs. 6% 19% vs. 29% 50% vs. 24% 124% vs. 59% 40% vs. 39% 37% vs. 18% 45% vs. 15% B IRR* 6,000 5,000 4,000 3,000 2,000 1,000 0 Takeover by Cobel E-2016 Sales in 2015: +81 Million Ranked #1 in Sales Value with 4.5% MS Ranked #1 in Sales Volume with 6.5% MS *At pubic price sales, MOH data 3

4 Abidi, Ranked #1 in Iran Pharmaceutical Market Production 2,475 Million units Contract Manufacturing 155 Million units Research & Development New Launches: 13 Products Re-Launches: 11 Products * Achievement in

5 Abidi, A leading Company in Iran Pharmaceutical Market Psychiatry/Neurology Diabetes Cardiovascular products Respiratory Anti-Infective Gastrointestinal Cough and Cold 5

6 Abidi: A Strategic Partner for Multinationals Production Production Production Secondary Packaging Primary Packaging 6

7 Abidi Organization Top Chart Board of Directors Total Personnel: 728 Managing Director A. Razavian Supportive Team HR Director H. Farzi Finance Director A. Tehrani Quality Management Director F. Liaghi Strategic Industrial Projects Director E. Moini Operation&Production Team Supply Manager M. Fazlian PIP Manager E. Ghazivakili R&D Director F. Jalilfar Operation Director Vacant Sales Manager Vacant

8 Job Creation for 469 People in the Past 6 Years Employment Opportunity for 305 Graduates in the Past 3 Years Total Personnel Education Management Change Associate degree 64 Bachelor degree Master degree PHD

9 Abidi Site Location 7 th Km west side of Tehran Good geographic location 20,000 sqm total area: 15,000 sqm existing site Additional 5,000 sqm location for future expansion plans 9

10 Production Capabilities Conventional OSD (Tablet & Capsule) Production Capacity: 3,500 Million units Oral Liquid Production Capacity: 20 Million bottles Hazardous OSD (Tablet & Capsule) Production Capacity: 3.5 Million Units 10

11 Abidi Site Plan Production Oral solid dosage production Oral liquid production Warehouses Raw material & packaging material warehouse Finished product warehouse R&D Laboratory QC Laboratory HP OSD Production Administration Utilities 11

12 Abidi Site Plan, Production Area Conventional OSD Production: Granulation Tableting & Encapsulation Packaging Oral Liquid Production Quarantine Area Quarantine Area Utilities 12

13 Past 5 Years Investments cvccvc v cvccvc v cvccvc v 7 Million Investment on construction & revamping 3 Million Investment on QC and R&D laboratories 10 Million investment on the new equipment cvccvc v 15 manufacturing & packing equipment new installation cvccvc v 40% capacity enhancement 13

14 Abidi after 5 years of transformation QC Laboratory 14

15 Abidi after 5 years of transformation Packaging Area 15

16 Abidi after 5 years of transformation Counting Line 16

17 Abidi after 5 years of transformation Syrup packaging room 17

18 Abidi after 5 years of transformation Syrup manufacturing area 18

19 Dispensing Rooms Area Dispensing Rooms Total sqm. 145 m² No of Dispensing Rooms Two Dedicated Rooms Project Delivery Time Operational Features Two dedicated dispensing rooms PAL/MAL Two dedicated HVAC One Dedicated Dehumidifier Qualified & Validated

20 Sampling Room Area Sampling Room Total sqm 41 m² Project Delivery Time Operational Features PAL/MAL 4 Fan filter units Air duct cooling/heating system Qualified & validated

21 Tablet Press, Kilian Equipment Tablet Press Brand Kilian - Germany Capacity 212,000 tab/h Project Delivery Time Operational Area 24 m² PAL/MAL Dedicated HVAC Dedicated Dehumidifier Features Qualified & Validated Ex-proof design Under License Manufacturing

22 Tablet Coater, Sejong Equipment Tablet Coater Brand Sejong - Korea Capacity 130 kg Project Delivery Time Operational Area 31 m² PAL/MAL Shared HVAC Ex-proof design Features Qualified & validated Under License Manufacturing

23 Blistering & Cartoning Line, IMA Equipment Blister & Cartoning Brand IMA - Italy Capacity 360 blister/min Project Delivery Time Operational Area 56 m² PAL/MAL Dedicated HVAC Dedicated Dehumidifier Features Qualified & Validated Under License Manufacturing

24 Bottle Counting Line, Countec Equipment Bottle Filling Line Brand Countec S. Korea Capacity 120 bottle/min Project Delivery Time Operational Area 271 m² PAL/MAL Two dedicated HVAC Dedicated Dehumidifier Features Qualified & Validated Under License Manufacturing

25 Blistering & Cartoning Line, Mediseal Equipment Blistering & Cartoning Brand Mediseal Germany Capacity 600 blister/min Project Delivery Time Operational Area 117 m² PAL/MAL Features Shared HVAC Qualified & Validated

26 Tablet Coater, Sejong Equipment Tablet Coater Brand Sejong - Korea Capacity 350 kg Project Delivery Time Operational Area 17 m² PAL/MAL TTW Design Shared HVAC Features Ex-proof design Qualified & Validated Under License Manufacturing

27 Blistering & Cartoning Line, Mediseal Equipment Blistering & Cartoning Brand Mediseal - Germany Capacity 300 blister/min Project Delivery Time End of 2016 Area 67 m² PAL/MAL Dedicated HVAC Dedicated Dehumidifier Room Features Qualified & validated Under License Manufacturing

28 Tablet Press, Sejong Equipment Tablet Press Brand Sejong - Korea Capacity 550,000 tablet/min Project Delivery Time End of 2016 Area 28 m² PAL/MAL Dedicated HVAC Dedicated dehumidifier Room Features Ex-proof design Qualified & Validated Under License Manufacturing

29 Blender Equipment Blender Brand TBD Capacity 1600 Liter Project Delivery Time Mid of 2017 Area 28 m² PAL/MAL Dedicated HVAC Dedicated dehumidifier Room Features Qualified & Validated Under License Manufacturing

30 Syrup Manufacturing & Packaging Line, B&S - IWK Equipment Syrup Line Brand B&S IWK Capacity 120 bottle/min Project Delivery Time Operational Area 380 m² PAL/MAL Room Features Two dedicated HVAC Qualified & Validated

31 New Expansion Project Project New Multi Purpose Building -1 Warehouse/Change rooms 0 Packaging 1 Canteen/Offices 2 Offices Project Delivery Q Time

32 New Expansion Project New Equipment Brand Project Delivery Time Granulation line (500 kg) Two Blenders TBD 2020

33 New Expansion Project Equipment Brand Project Delivery Time Two New Tablet Coaters Tablet Press (Replace) TBD 2020

34 High Potent OSD Manufacturing Facility Phase A: Small-scale manufacturing & packing facility Total Capacity: 3mn units of OSD Phase B: Medium-scale manufacturing & packaging facility, Total Capacity: 34

35 High Potent OSD Manufacturing Facility The Facility has been design based on Campaign Production concept with following primary & secondary containment strategies: Primary Containment: Secondary Containment: Isolator system Personnel Protective Equipment (PPE) Campaign Production Negative pressure in production rooms & corridors Full fresh air into the clean room HEPA filters for inlet & exhaust air Bag-in bag-out for AHU Separated PW loop Separated wastewater system 35

36 HP OSD Manufacturing Facility Phase A Blister Capsule Filling Blender Tablet Press Weighing IPC Corridor Coater Dirty Storage Area PAL1 PAL2 Washing Clean Storage Area First AL 36

37 HP OSD Manufacturing Facility Phase A Equipment Situation Weighing Glove Box Isolator Installed Capsule Filling with Isolator Installed Tablet Press with Isolator Apr 2017 Coater with BIBO Equipment Apr 2017 Blistering Machine Apr 2017 IPC Down Flow Booths Apr

38 HP OSD Manufacturing Facility Phase A 38

39 HP OSD Manufacturing Facility Phase A 39

40 HP OSD Manufacturing Facility Phase A 40

41 HP OSD Manufacturing Facility Phase B EU-GMP complaint facility Top European highly-contained equipment Total capacity: 40 mn units OSD 8 mn units capsule 32 mn units tablet Location: Opposite side land Project consultant: CSV Lifescince - Italy Project delivery time:

42 Hazardous Production Phase B and R&D Center Location Hazardous OSD Production Phase B Floor Area Sqm Warehouse Change Room 80 Technical Utilities Production 650 Technical - HVACs R&D Lab 160 Production (Packaging) 400 Offices Technical - HVACs 370 QC Laboratory 110 Others Stairs, Corridors, etc. 780 Total 4000 New R&D Center Floor Area Sqm Bioequivalency Technical - Utilities 120 Warehouse 80 0 R&D Laboratory 500 R&D Laboratory Technical 115 Archive Offices 300 Technical - HVACs 180 Others Stairs, Corridors, etc. 555 Total

43 Phase B and R&D Center Project Time Schedule & Cost Phasing Hazardous Production Phase B and R&D Center Project Tasks Conceptual Study Consulting Company Selection & Contract Basic & Detail Design Shahrdari Construction license Const. Contractor Selection & Contract Clean Room Construction Selection Production Equipment Order & Receiving Ordering & Receiving Utilities Order & Receive Warehouse & Office Equip. Construction Operation Implementing Utilities R&D Laboratories Construction Clean Room Construction Production Equipment Install. & Com. Offices, Warehouse,, Qualification & Validation Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Project Delivery Cost Phasing (m )

44 Abidi 6 Years Action Plan GMP Compliance on the Site Goal Upgrade the current site to comply with GMP Compliance requirements (Local, PICS & EU GMPs) and obtain certification Personnel Infrastructures Production & Control Materials Methods & Measures Job Description Training Quality Org. Chart Facilities Utilities Equipment Maintenance Analytical Method Validation Stability Process Validation Cleaning Validation Approved Supplier list Specification Supplier Quality Management Quality Systems Reg. compliance

45 Ratio of Quality People in the Site QM QA QC Regulatory Quality: 77 Production Technical Warehouse Supply Chain R&D HR Project IP Management Finance Admin Sales & Marketing H.S.E

46 Certification and Accreditation GMP certificate by MOH 2014 Line 7 (Approved by Sanofi) 2015 Syrup Line 2016 Countec Line (Approved by Sanofi) Accreditation by MOH and Institute of Standard & Industrial Research 2013 Quality Control Laboratory Accreditation of MOH ISO17025 in Quality Control Laboratory (in progress) ISO from TUV NORD : : :

47 Personnel Job Description: Job description for key people has been finalized 120 job descriptions are defined 102 job descriptions have been finalized Training: Planning 16 training modules for GMP & Quality Conducting 5 training modules Key documents training Supervision of documents training 18 job descriptions will be finalized by the end of training modules will be conducted by mid 2017 Quality Org. Chart: Site quality organizational charts has been finalized 47

48 Production & Control Qualification & Validation: Site Validation Master Plan Cleaning Validation Master Plan Cleaning Validation (Line7) Process Validation (Sanofi products) Transport Validation (Sanofi products) Temperature Mapping (According to Plan) Facilities, Equipment & Utilities (FEU) (According to Plan) Analytical Method Validation Cleaning Validation Syrup Line (end of 2016) Countec line (end of 2016) Process Validation Transport Validation Temperature Mapping Facilities, Equipment & Utilities (FEU) Calibration: Calibration YTD Internal Calibration External Calibration NCR Equipment

49 Materials Material (Supplier Quality Management): The SOP & method is in place List of approved suppliers (Raw materials & packaging materials) Define specification (Raw materials & packaging materials & finished product)(new launches) Supplier quality audit and quotation (According to plan) Define specification (Raw materials & packaging materials & finished product)(old products) Supplier quality audit and quotation 49

50 Methods & Measures GMP and Quality Systems: Inspection CAPA Deviation System Quality Risk Management Change Control Management PQR PMQC Pharmacovigilance Complaints and recall Regulatory compliance 50

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