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Your Integrated Female Health Company

Your Integrated Female Health Company.

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Your Integrated Female Health Company

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  1. Your Integrated Female Health Company

  2. NAARI AG is a Swiss Pharmaceutical company focused on female health with an emphasis on hormones. We are an integrated player producing Fermentation Intermediates, Active Pharmaceutical Ingredients and Finished Dosage Forms supported by our in-house R&D in each domain. Our current portfolio consists of niche generics and a robust innovative pipeline. www.naari.ch

  3. VISION NAARIaspires to be a leading niche pharmaceutical company which is integrated in research, development, manufacturing and marketing of female hormones. www.naari.ch

  4. MISSION • Our mission isto become a leading supplier of hormonal products by: • Manufacturing highest quality products in state-of-the-art facilities, compliant with the norms laid down by Regulatory Agencies such as WHO, USFDA (USA) and EMEA (Europe) • Offering innovative products in the female health space • Competitive pricing www.naari.ch

  5. NAARI’S STRENGTHS • 100% vertically integrated–within-house R&D and production of Fermentation Intermediates, APIs and Finished Dosage Forms • World-renowned result-oriented team of experts across senior management, fermentation, synthetic chemistry and formulation R&D, clinical development, production and marketing • State-of-the-art infrastructure–manufacturing units and R&D labs equipped with modern technology and equipment • Strategic partnerships to minimize time to market and to gain access to technologies that do not exist in-house • Clear and dedicated focus on female health www.naari.ch

  6. NAARI’S PHILOSOPHY:QUALITY • Maintaining highest quality standards is the cornerstone ofNAARI’s development and manufacturing philosophy • A quality system based onvery vigilant quality control operates through the entire gamut of R&D and production to ensure the quality, safety and efficacy in all NAARIproducts www.naari.ch

  7. NAARI’S TEAM • Dr. Manfred A. May, Chairman (Widely respected as a veteran in the field of pharmaceuticals, in recognition of his expertise has held a portfolio of senior positions in the pharmaceutical industry around the world including MD Wulfing Pharma, Global Head of the Formulation business & Board Member Merck Darmstadt , MD Gehe Pharma ) • Prof. Dr. Michael Oettel, Director (Former Head of Research - Institute of the Academy of Sciences in the G.D.R.; Head of  R&D at Jenapharm and Head  of the Scientific Marketing Female Healthcare at Schering AG; Inventor of Dienogest and Former Member of WHO’s  Human Reproduction Program). • Mr. Prithi S Kochhar, CEO(Fourth generation pharma entrepreneur with management experience in R&D, manufacturing (in India & China) and marketing in the CIS and India) • Dr. Malcolm Ross, Board of Advisors(Has vast experience of 36 years in the pharmaceutical industry and has held eminent positions like Head of Pharmaceutical Analytical Research Teva Pharmaceuticals, Vice President R&D Taro Pharmaceuticals, Director Research Special Projects of Polpharma, President Generapharm) www.naari.ch

  8. PARTNERSHIPS • At NAARIwe understand that in the fast evolving and ever-changing pharmaceutical industry we cannot do everything ourselves. To capitalize opportunities and to reduce time to market, we believe it is important to have strategic and long-lasting relationships with partners that specialize in areas of development and manufacturing where NAARI does not have an in-house strength. To name a few, NAARI shares partnerships in the field of: • Finished Dosage Forms • EU Partnership: In the initial two years when NAARI was executing its own manufacturing and development facilities, we entered into a strategic partnership with a company in the EU that had development and manufacturing capabilities for solid oral female hormones and was already approved by the European authorities. This enabled us to have our first product ready even before our facilities came on stream. • Diagnostics • We have a strategic partnership with developer and manufacturer of Medical Devices with whom we have developed (and are now producing) third generation Pregnancy and Ovulation test kits. In the last couple of years these products have received the CE market and are approved for sale in almost all countries in the world. • Marketing Partnerships • NAARIis currently planning it’s own marketing set up only in Russia and the CIS. For these markets we have our own products and are also seeking partnerships to in license products in the female health space. For markets than Russia and the CIS, NAARI works with partners that have sales and marketing infrastructures and either have a presence or future interest in the female health space. www.naari.ch

  9. INTELLECTUAL PROPERTY • NAARI has a pipeline of patents to protect its products • Our patents span across • Fermentation • Chemical Synthesis • Formulation Manufacturing www.naari.ch

  10. OUR INFRASTRUCTURE • Basel, Switzerland • Corporate Headquarter and Marketing Office • India • Noida • Fermentation R&D • Synthesis R&D • Analytical R&D • Regulatory Affairs • Kashipur • Fermentation Production • Intermediates and API Manufacturing • Rudrapur • Formulation R&D • Formulation Analytical R&D • Formulation manufacturing www.naari.ch

  11. NOIDA Lab Area : 4600 sq ft Number of Scientists: 25 • Synthesis R&D • Dedicated to steroid and hormone research with a special section for only estrogens • Analytical R&D • Developing, standardizing and validating analytical methods • Conducting stability studies of APIs www.naari.ch

  12. KASHIPUR • Total Area: 48,000 Sq. meters • Built-Up Area: • 80 Sq. meters for Fermentation Block • 220 Sq. meters for intermediates Block. • 100 Sq. meters for API manufacturing Block I • 240 Sq. meters for API manufacturing Block II • 790 Sq. meters for Warehouse Block. • 125 Sq. meters for Admin/QA/QC Block. • 1240 Sq. meters for Utility Block • Capacity: 25-30 tons of steroid and steroid intermediates per annum • Reactors capacity: • Intermediates – 14700 Liters • APIs – 2500 Liters www.naari.ch

  13. RUDRAPUR WHO GMP certified manufacturing unit (Gearing up for USFDA , ANVISA, WHO – Geneva, MHRA, BfArM Germany inspections • Total Area: 45, 000 Sq. meters • Built-Up Area: • 2450 Sq. meters for Non –Hormone facility • 500 Sq. meters Hormone facility • 500 Sq. meters Administration & QA/QC facility • 150 Sq. meters Utility facility • 830 Sq. meters ware house main pharma block • 130 Sq. meters Ware house hormone block • Equipments: All modern equipment suitable for manufacturing of hormonal products and packaging facility • Capacity: General Pharma Block Hormone Block • Capsules: 5.4 Billion/Year o 1.4 billion tablets/year • Tablets: 2.3 Billion/year www.naari.ch

  14. FORMULATION R&D, RUDRAPUR • Capacity: The equipment are suitable to produce 0.5 kg to 5.0 kg of batch size • Equipments Available: • Vibro sifter & Multimill • Rapid mixer granulator • Fluid bed equipment • Octagonal blender • Auto coater • Friability, dissolution and hardness tester • Induction seal machine • Remi stirrer • Resch dryer www.naari.ch

  15. MARKET PRESENCE(of Intermediates, APIs & Drug Products) • APIs – In-house consumptionand customers worldwide including Europe and North America • Intermediates – In-house consumption and supply contracts with innovative companies in Europe that are forerunners in the female hormone space • Finished Dosage Forms – • Supply contracts with major Donor agencies and Institutional buyers like DKT, National Ministries of Health • EU, North America & Brazil: Agreements with big pharma and generics companies for licensing and supply of the products we are developing • Developing markets: partnerships with major regional companies in some markets and own infrastructure in other markets www.naari.ch

  16. OUR BUSINESS MODEL • CIS: Our business model here is to set up our own niche branded female health company supported by our own sales force promoting specialized generics & innovative products. • We started filings in Q1 2011 and already have 5 approvals and numerous others in the pipeline • A sales force of over 100 medical representatives is planned in the next 36 months • In Q4 2011 Naari completed the acquisition of it’s first brand from Bayer for an Endometriosis product • Apart from our own portfolio, we (NAARI) are licensing a number of products to expand our portfolio. Currently we license a contraceptive from the EU and a GnRH antagonist for Endometriosis CIS www.naari.ch

  17. OUR PRODUCT PORTFOLIO • Our product portfolio includes: • Intermediates • Active Pharmaceutical Ingredients (APIs) • Finished Dosage Forms (FDFs) • Nutraceuticals • Diagnostics www.naari.ch

  18. OUR APIs www.naari.ch

  19. OUR UPCOMING APIs www.naari.ch

  20. OUR INTERMEDIATES www.naari.ch

  21. OUR UPCOMING INTERMEDIATE www.naari.ch

  22. OUR FORMULATIONS (1) www.naari.ch

  23. OUR FORMULATIONS (2) www.naari.ch

  24. OUR DIAGNOSTICS www.naari.ch

  25. OUR NUTRACEUTICALS • Along with Diindolylmethane, which has come to market recently, Naari has another nutraceutical coming up very soon: www.naari.ch

  26. OUR INNOVATIVE PIPELINE • We have a robust pipeline of innovative products at various stages of development each of which has different regulatory strategies based on the target market www.naari.ch

  27. For further information contact us @ THANK YOU Arnold Bocklin - Strasse 11 4051 Basel, SwitzerlandTEL: +41 615880242FAX: +41 615684352 Email: info@naari.ch www.naari.ch

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