SANA PHARMA: MARKET DRIVEN RESEARCH

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2 SANA Pharma is a fast growing Research Company with a broad spectrum of pharmaceutical services managed at highest standard level. SANA Pharma has been recognized as one of the fastest growing companies in the region in 2011 & 2012 (All world network and Harvard business school classification). Independent R&D with ISO certified laboratories, provide Tech transfer projects and analytical services. Market driven research company focusing on market needs. Integrated pharmaceutical engineering services. SANA PHARMA: MARKET DRIVEN RESEARCH

3 SANA Vision To be the outsourcing partner of choice to generic pharmaceutical companies in the region and world wide. SANA Mission SANA Pharma objectives are to increase the pharmaceutical companies' sales and profits through development/licensing pharmaceutical products, analytical services, technologies to their pipelines. SANA Pharma is working on licensing an advanced and niche projects to pharmaceutical companies in order to maximize their profits and reduce their competition. SANA Pharma, and through its qualified laboratories, and being work under international GLP standards (ISO 17025, 2005) provides various technical services at an affordable cost. SANA PHARMA: MARKET DRIVEN RESEARCH

4 Established by technocrats and expertise from Pharma industry in Currently has business projects in more than 24 countries including Europe. Turnover in 2015: $3.5 Million. Efficient network in MENA region and EU. Activities/History Year Activities Pharmaceutical Service activities: Product development, Contract analysis, Regulatory consultation Service activities linked with longterm supply agreements or royalty based or profit sharing (niche products) Started market authorization business, and marketing medicated cosmetics, CNS products in Jordan and MENA region (based on contract manufacturing) Started the first manufacturing site for medicated cosmetics in Amman-Jordan Integration of product development, API business and technology transfer Developed new processes for Sofosbuvir API and established Technovir company to handle the business of HCV products in Egypt and the region. Entering new markets in EU and Asia. SANA PHARMA: MARKET DRIVEN RESEARCH

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6 General Manager Advisory board Financial Manager R&D Advisor Development Manager Regulatory Manager Business Development Manager Quality Manager Formulation S.H Pre-formulation S.H Regulatory supervisor Quality Manager Analysis S.H /Technical Manager Microbiology supervisor Regulatory Officer QA officer Microbiology QA officer physiochemical Analysis supervisor Chemical Analyst Microbial testing: pharmaceutical, cosmetic product and water Compliance, documentation control,internal audits Analytical Services,analytical methods,development and validation stability SANA PHARMA: MARKET DRIVEN RESEARCH

7 Site map/technical departments SANA PHARMA: MARKET DRIVEN RESEARCH

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11 As key success factor

12 Department # of employee QC 14 (8 females) QA 4 (2 females) Microlab 4 (3 females) Development and technology transfer 8 (3 females) Regulatory 6 (6 females) HR/Finance 4 (2 females) Technical director Mohammad Alfar GM Samer Najjar Business development 2 Sales & Marketing 10 (4 females) Quality director Mohammad Al Far SANA PHARMA: MARKET DRIVEN RESEARCH

13 M.Sc. Pharmaceutical technology, with focused research on transdermal drug delivery system and drug release from sustained release matrices. 20 years of experience in pharmaceutical research. 7 Years of them as R&D manager at Joswe medical and responsible for development their pipeline. Extensive knowledge and experience of analytical methods development, validation, Pre-formulation, stability testing, and scaling up of products. Extensive knowledge and experience of regulatory filing including CTD dossiers preparation and response to regulatory inquiries. Good knowledge of IPR issues related to formulation and registration processes. Extensive knowledge of pharmacokinetics related to drug development and conduction of bioequivalence studies, with solid experience in monitoring and auditing of bioequivalence studies and CRO's. Good knowledge and experience in cgmp and site inspection. Member of JFDA committees for quality control and site inspection/approval

14 Former R&D director at Pharma international. 26 years of experience in pharmaceutical research at DAD, Hayat Pharma and PIC. Extensive knowledge and experience of development of different dosage forms including sustained release product and drug combination and more than 120 product successfully developed with BE successful rate > 95%. Successful product registration in regulated markets including EU. Good knowledge of IPR issues related to formulation and registration processes. Extensive knowledge of pharmacokinetics related to drug development and conduction of bioequivalence studies. Good knowledge and experience in cgmp and site inspection. Member of JFDA committees for site approvals and a JFDA quality inspector.

15 God bless his sole B.Sc. (Pharm.), M. Phil., JPA Intensive marketing experience at regional level (MENA), Near East, Indian subcontinent, Far East and Europe Uncompromising ethics and transparent communications underpin business-focused value proposition that facilitate competitiveness via high standard service. A result oriented professional with leadership skills, skilled in bridging differences between diverse agenda and directing them to a common goal, in unifying team efforts and optimizing its dynamics, and harnessing strategic and operational drivers to achieve the desired goals. Eager to execute a stretched role that involves planning, adding for growth, subtracting for profit, improvement of business processes and broad understanding of competitiveness that will consequently alter the status quo of the business. Acknowledged for well defined understanding of the generic pharmaceutical business and capacity to identify and align emerging markets needs and emerging technologies effects with products and services. with emphasis on Pharmaceutical biotechnology products, Oncology and potent drugs.

16 B.Sc. pharmacy 10 years experience in registration and regulatory departments at Joswe medical, Tabuk Pharma and Sana Pharma. Expert in CTD files preparation (Common technical documents) and EU regulations. Excellent experience in registration requirement in MENA region. Working on registration at regulated markets. Excellent experience and knowledge of documentation and archiving. Expert in Pharmacovigilance and post marketing surveillance. Excellent experience in preparing PSUR.

17 BSc. Applied Chemistry 20 years of experience in pharmaceutical analysis. Quality inspector for JAS. Expert of GLP and ISO quality system Working under regulated analytical environment. Expert of analytical method development and analytical method transfer. Validation and stability studies.

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19 ISO Certified Laboratories SANA PHARMA: MARKET DRIVEN RESEARCH

20 Testing of finished product. Testing of active ingredient including impurity profile. Stability studies. Comparative dissolution studies of solid dosage forms In vitro release from semisolid products. Analytical method development and validation. Microbial testing of material and finished products of pharmaceutical and cosmetic products. Pharmacodynamic studies using comparative enzymatic assay. SANA PHARMA: MARKET DRIVEN RESEARCH

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23 Dissolution Apparatus for solid Dosage form Franz Diffusion cell for semisolid dosage form SANA PHARMA: MARKET DRIVEN RESEARSH

24 Provide method development experimental design, progress report, method validation protocol and report and method monograph. SANA PHARMA: MARKET DRIVEN RESEARSH

25 SANA PHARMA: MARKET DRIVEN RESEARSH With a network of ICH stability storage facilities, we offer an extensive capacity and a range of conditions including climatic walk in chambers, cabinets and refrigerated storage which are fully controlled and monitored. 40 C 75%RH 40 C 75 %RH Stability Chambers 30 C 65 %RH

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27 Qualified to provide the following tests: Total microbial count Microbial contamination Bioassay Preservative effectiveness LAL test Sanitizer Efficacy test SANA PHARMA: MARKET DRIVEN RESEARCH

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29 Micro lab SANA PHARMA: MARKET DRIVEN RESEARSH

30 Pilot area SANA PHARMA: Market Driver Research

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33 SANA PHARMA: THE TECHNICAL PARTNER OF CHOICE JFDA (Jordan food and drug administration) Sana laboratories were inspected and approved by JFDA for drug development, stability testing, contract analysis and technology transfer. SANA NOW IS RECOGNIZED AS REFERENCE LABORATORY ISO Sana laboratories were inspected by Jordan Accreditation System (JAS) and approved as reference laboratories for contract analysis (ISO/IEC 17025). Sana pharma laboratories have been inspected by European CRO in Austria, Labatec (Switzerland) and have been approved for conducting various analytical testing for finished products.

34 SANA PHARMA: MARKET DRIVEN RESEARCH Publications

35 Sana pharma involved in many research projects in different areas. The following were published in an international journals: Solubility of Diclofenac sodium, effect off additive. A comparative study with Diclofenac Diethylamine, Drug development & industrial pharmacy, The use of Drug excipient in designing and evaluation of TDDS, under publication. Spectroscopic and HPLC methods for determination of Alendronate in tablets and urine, Talanta 64(2004) Olanzapine Inhibits Glycogen Synthase Kinase-3β: An Investigation by Docking Simulation and Experimental Validation, European Journal of pharmacology, under publication. Sustained release suspension of an antiepileptic for pediatric applications", patent under filing in cooperation with a group of researchers, faculty of pharmacy, UJ. Modulation of Buspirone HCl release from hypromellose matrices using chitosan succinate: Implication for ph-independent release. European journal of pharmaceutics and biopharmaceutics (2008). SANA PHARMA: MARKET DRIVEN RESEARCH

36 SANA PHARMA: MARKET DRIVEN RESEARCH Novel HPLC method for determination of Sitosterols in herbal products, (under publication). Determination of Primeverin and Primulaverin in cough syrup containing Primula root extract, (under publication). SANA PHARMA HAS DEVELOPED NOVEL PROCESS FOR TOLPERISONE TABLET (MUSCLE RELAXANT) AND IN THE PROCESS OF PATENT FILING.

37 Exposure to regulated Market SANA PHARMA: MARKET DRIVEN RESEARCH

38 SANA PHARMA: MARKET DRIVEN RESEARCH CTD filing. Response to deficiency letters. Translation of leaflets, patents, Expert reports: clinical and non clinical. QOS PSUR Readability of the labeling and package leaflets. PK and biowaiver reports Re-registration file review and update. Stability study review and justifications.

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40 Tracking records & the added value SANA PHARMA: MARKET DRIVEN RESEARCH

41 SANA PHARMA: MARKET DRIVEN RESEARSH Through collaborative integration with international engineering companies and manufacturers of machineries, utilities and cleanrooms. Sana pharma provides: Turnkey projects Machineries and utilities Cleanrooms. Validation master plan and full documentation system

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43 SANA PHARMA: MARKET DRIVEN RESEARCH Development of oncology pipeline. Development of HCV pipeline. Development of CNS pipeline. Injectable product pipeline. Development of novel combination and super generic products. Qualification of JFDA laboratories according to ISO (Project supported by EU union). Development, manufacturing and selling niche medicated cosmetic products in Jordan and MENA. Development of OTC products for a Swiss company. Novel manufacturing process development for challenging drugs. Successful technology transfer projects in MENA region and EU. Successful process development of two API s: Fingolimod & Sofosbuvir integrated with finished product dossier development.

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45 SANA PHARMA: MARKET DRIVEN RESEARCH Strategic customer Hikma Elkendi (Algeria) Pharma international (PIC) Labatec Switzerland Saiph (Tunisia) Biopharm (Algeria) Razes, Algeria The added value First generic pipeline of potential products including Quetiapine XR, Tacrolimus ointment, Sitagliptin, Orlistat This company started at the same time with Sana pharma and sales increased exceeding 140 Million in Sana pharma is responsible for 30-35% of Elkendi pipeline A pipeline product including MEBO, orlistat, sofosbuvir, Fingolimod, and CNS pipeline Tolperisone F/C tablet, with novel manufacturing process, vitamin D3 high dose, CV, CNS pipelines development CV, CNS pipelines development Injectable pipeline

46 Sana Pharma technology transfer projects added 150 Millions sales in 2015 for customers received Sana dossiers of different therapeutic classes. SANA PHARMA: MARKET DRIVEN RESEARCH

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48 Sana Pharma has developed, registered, manufactured and marketed a pipeline of niche medicated cosmetics/cosmeceuticals in Jordan and MENA region. The main category of Sana products cover Scars, dermatological product, muscles and joints care products, male & female lubricants. CE mark obtained. SANA PHARMA: MARKET DRIVEN RESEARCH

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