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Oppi presentation


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Oppi presentation

  2. 2. © SCHOTT KAISHA Why should SCHOTT KAISHA be given this award ?  Joint Venture : 1991 commenced operation 1996 Opening of new facility KAISHA 2006 Investment in sterile PFS) facility KAISHA has established it’s credentials in the Indian Pharma Market with it’s trade mark of exclusivity and excellence having crossed a landmark of 1 billion INR for FY 08-09 A company is poised to touch sales of 1.5 billion in FY 09-10 2.23 billion € sales & 289 million € capex Production plants and sales offices in 41 countries 17,300 employees Pharmaceutical Packaging (Business Segment) 260 million € sales & 40 million € capex 3,100 employees SCHOTT KAISHA today…  State-of-the-art plants  Complete product portfolio to customers – „one stop shop“  5 million pcs. of ampoules, vials, PFS and cartridges per day  ISO: 9001:2000 certified  1500 dedicated employees  Strong partnership with SCHOTT group, Germany
  3. 3. © SCHOTT KAISHA Slide 3PPA/KSD,BA March 2009 Multiple locations to increase capacity and minimize risk  The company's inherent strength as a premier pharma packaging group, primary factor of the company tieing up with strategic joint venture with a global giant and market leader in the pharmaceutical glass packaging segment – SCHOTT forma vitrum to become SCHOTT KAISHA Private Limited
  4. 4. © SCHOTT KAISHA SCHOTT KAISHA – your „one stop shop“ for tubular glass containers for injectable drugs  1 to 30 ML  OPC; Flame cut  Closed  (Rota/Marzocchi)  Color break and Identification bands  Printed  1 to 50 ML  Crimp neck  Screw neck  Lyophilization vials  Chromatography  Diagnostic vials  Special vials  Blowback  Siliconized  Low alkali  0.5 to 5 ML  Staked-in Needle  Luer Lock and LuerCone formats  Sterile tub and nest configuration Vials Dental cartridgesPre-fillable syringesAmpoules  1.8 to 3 ML  Printed  Siliconized
  5. 5. PHARMACEUTICAL PACKAGING SCHOTT KAISHA brings technological products from SCHOTT forma vitrum product range (1)  0.5 ml to 50 ml  Break Systems: - OPC (one-point cut) - color-break ring  Colour rings on the stem or body  Printed ampoules (heavy metal free colours)  2 ml to 100 ml  Resistance to breakage  Transparency comparable to glass  Excellent barrier properties  High chemical resistance  Broad variety from 1 ml to 100 ml  With or without blowback  Special designs for lyophilization  Dual-chamber (“mixer”) vials  Screw neck vials Vials made of glass Cartridges made of glass SCHOTT TopPac® Vials made of COC polymer Ampoules made of glass  For pen systems  For pump systems  Dual-chambered cartridges  Auto-injectors  Needle free injectors  Dental cartridges Broad range of ampoules, vials and cartridges
  6. 6. PHARMACEUTICAL PACKAGING Coated vials for sensitive drugs and vials for special applications  Containers with a quartz- like inner surface for im- proved chemical stability and inertness  Particularly suited for bio- pharmaceutical products with adsorption tendencies, high pH values, susceptibility to a shift in pH value, sensitivity to traces of metal ions, complexing agents like  Inner glass container of pharmaceutical type I glass for best compatibility  Specially shaped glass design for highest pressure resistance  Outer polymer shell for protection and mechanical strength  Choose your own design and color  Optimized gemetry of the vial  Hydrophobig coating Advantages:  Elegant lyophilisation cake  Less disruption of dry material  Less adhesion to glass surface  Improved drug removal after reconstitution  Reduced glass breakage  Improved heat transfer SCHOTT TopLyo™ SCHOTT PURGARD® SCHOTT Type I plus® SCHOTT KAISHA brings technological products from SCHOTT forma vitrum product range (2)
  7. 7. PHARMACEUTICAL PACKAGING Dropper pipettes and plastic closure systems  Pre-washed and siliconized  Integrated printing to avoid contamination  Assembled with caps and droppers  Special packaging ready for sterilization  screw neck vials + screw caps, tablet bottles + snap caps  Standards: GL 14, GL 18 and GL 22  Special shapes on customer request Plastic closure systems and custom moulding Dropper Pipettes SCHOTT KAISHA brings technological products from SCHOTT forma vitrum product range (3)
  8. 8. PHARMACEUTICAL PACKAGING Slide 8 SCHOTT forma vitrum - setting performance standards in parenteral packaging MATERIALS MATERIA IALS MATERIALS MAT TERIALS MATERIALS PRODUCTS PRODUCT TS PRODUCTS PRODU PRODUCTS PRODUCT TECHNOLOGY TECHN NTECHNOLOGY TECH LOGY TECHNOOLOGY A unique selection of material technologies, product designs and quality options to your choice StandardLineStandardLine ClearLineClearLine TopLineTopLine  Continuous research and development assures that our portfolio meets the demands of today’s and tomorrow’s market place, from standard up to sophisticated customer requirements. GLASSGLASS POLYMERPOLYMER COATING TECHNOLOGYCOATING TECHNOLOGY  Our expertise on material technology and excellent raw materials are the basis for innovative product solutions. VIALSVIALS SYRINGESSYRINGES AMPOULESAMPOULES CARTRIDGESCARTRIDGES  SCHOTT forma vitrum offers a complete product range: a “one-stop-shop” for our customers.
  9. 9. © SCHOTT KAISHA Investment, Long term commitment & accreditation (1) Investments in Mio.INR 4 24 94 103 181 293 400 0 50 100 150 200 250 300 350 400 450 1991 1996 2000 2003 2005 2006 2008 Mio.INR Production capacity in Mio.Pcs. Per day 1 5 0 1 2 3 4 5 6 1996 Today Huge investments made in infrastructure, technology, and people to increase capacity and improve quality
  10. 10. © SCHOTT KAISHA Investment, Long term commitment & accreditation (2) Future: Greenfield in Baroda SCHOTT KAISHA is planning to build a new production plant with technology transfer from SCHOTT to offer “SCHOTT forma vitrum StandardLine” quality ampoules and vials to Indian customers
  11. 11. © SCHOTT KAISHA Slide 11PPA/KSD,BA March 2009 ISO 9001: 2000 certification and DMF is available for all productsISO 9001: 2000 certification and DMF is available for all products Investment, Long term commitment & accreditation (2)
  12. 12. © SCHOTT KAISHA Slide 12PPA/KSD,BA March 2009 SCHOTT KAISHA supplies to all major pharma companies in India Aristo Laboratories. Cadila Healthcare Ltd.. Cadila Pharmaceuticals Ltd. Chiron Behring Vaccines Pvt. Ltd. Harson Laboratories Intas Pharmaceuticals Ltd. Sun Pharmaceuticals Ltd. Troikaa Pharmaceuticals. Ltd. Vulcan Labs. Cosme Matias Menezes group Merck Ltd. Serum Institute of India. Gland Pharma Ltd.. Bharat Biotech Biocon Strides Arcolab Ltd.. Tablets (India) Ltd. Aristo Laboratories Astra Zeneca Bayer (India) Ltd. Sanofi Aventis Ltd. Blue Cross Laboratories Ltd. Cipla Ltd.. IPCA Laboratories Ltd. Laboratories Griffon Ltd. Lyka Labs Ltd. Neon Laboratories Ltd. Novartis India Ltd.. Pfizer Ltd. Umedica Laboratories. USV Ltd.. Glaxo Smith Kline Pharmaceuticals. Ltd. Alkem Laboratories Ltd. Nicholas Piramal (India) Ltd. Dr.Reddy’s Lab’s. Panacea Biotec Windlass Biotech. Ranbaxy
  13. 13. © SCHOTT KAISHA Slide 13PPA/KSD,BA March 2009 Exports to over 30 countries Guatemala Senegal UK Russia Australia Egypt Uzbekistan S Africa New Zealand Dubai Nigeria Ghana Zambia Syria Malaysia Mexico France Kenya Indonesia Bangladesh Sweden Israel Costa Rica Philippines Ethiopia Chile USA Italy Yemen S.Korea
  14. 14. © SCHOTT KAISHA Slide 14PPA/KSD,BA March 2009 Consumer Delight  Flexibility in reacting to customer needs  Transparency, reliability, trust and stability with the customer  SCHOTT KAISHA is setting standards in the Indian market  The only company in India with the full portfolio of ampoules, vials, prefillable syringes and cartridges  SCHOTT KAISHA and its partner companies can offer “one stop shop” solution to the pharmaceutical industry for primary and secondary packaging materials • Secondary packaging materials (aluminium seals, cartons, boxes) • Sovereign Pharma Pvt. Ltd contract manufacturing for injectables  Quality awareness and continuous desire to improve at all levels (product, service, people)  JV with SCHOTT pharmaceutical packaging – global leading supplier of tubular glass containers for injectable drugs
  15. 15. © SCHOTT KAISHA Slide 15PPA/KSD,BA March 2009 Innovation and Development  Camera Inspection for Physical and Dimensional parameters  First to produce & supply Siliconised ampoules and vials  First to market sterile vials  First company in India to produce 140 ml Tubular vial
  16. 16. © SCHOTT KAISHA Adherence to Environment, Health and Safety Committed to GMP guidelines to create the healthiest climate for your packaging  Advanced air-handling systems  Air curtains at entry and exit points  Fully air-conditioned packing area  Cleanliness drive over 3 shifts  1500 strong workforce trained in principles of GMP  Medical check-ups at regular intervals  Use of personal protective gear
  17. 17. © SCHOTT KAISHA
  18. 18. © SCHOTT KAISHA Slide 18PPA/KSD,BA March 2009 State-of-the-art ampoules production lines production technology  Forming machines with 30 sub stations  State-of-the-art production lines and electronically led after forming line for ampoules  All cutting, glazing, checking, annealing and packing of ampoules is done in a continuous process  computerized controls and in-built camera ensures close monitoring of the production process and strict adherence to specifications  Clean environment – only tubing used for conversion is brought into the production area
  19. 19. © SCHOTT KAISHA Slide 19PPA/KSD,BA March 2009 Broad range of vials from plain neck to screw neck to lyophilized to siliconized vials Tubular vials range : 1 to 120 ml  Plain and Screw neck  Vials for lyophilization  Chromatography vials  Sterile vials  Special vials  Siliconized vials  Blow back vials  Low alkali vials Manufacturing technology  In-built checks in the manufacturing process  Stringent checks: Internal and external diameter, lip height and length  Camera inspection of vials for dimensional, aspects and inclusions in empty vials
  20. 20. © SCHOTT KAISHA Slide 20PPA/KSD,BA March 2009 Safepac™ glass prefillable syringes (PFS)  Range from 0.5ml to 5ml  Luer Tip  Luer Tip with Lock  Fixed Needle with Rigid NS and Flexible NS  Custom Printing/Graduation  Baked Silicone (for LL and LC)  Sterile Tub Pack 100/160  Non-sterile in Rondos  Nested stoppers
  21. 21. © SCHOTT KAISHA Slide 21PPA/KSD,BA March 2009 State-of-the-art production process and components from world class suppliers  Barrels: SCHOTT Fiolax® USP Type I Glass  Rubber Components: Wide spectrum of formulations from Stelmi, Helvoet and West (Fluro Tec® coated and Omniflex© included) Rigid Needle Shield and Flexible Needle Shieid option available.  Needles: Procured from Japan conforming to highest international standards SUS 304, as per JIS-G 4305- 1991. Lancet Point and 5 Cut option available.  Adhesive: Medical Grade Loctite® , USA  Silicon: Medical grade Dow Corning 360, USA  Tyvek™ Sheets from Oliver Medical, Dupont, USA  Plunger Rods: PP, PS and PC in different colors.  Custom Printing on barrels with graduation or logo.
  22. 22. PHARMACEUTICAL PACKAGING Slide 22 Introduction to SCHOTT
  23. 23. PHARMACEUTICAL PACKAGING Slide 23 Home Tech The SCHOTT Group Pharmaceutical Systems Electronic Packaging Solar Advanced Materials Flat Glass Fiber Optics
  24. 24. PHARMACEUTICAL PACKAGING Slide 24 syringes, cartridges, vials, ampoules made of special glass special glass tubing pharmaceutical excellence …and high tech polymer Business Unit Pharmaceutical Systems: Tubing & Pharmaceutical Packaging
  25. 25. PHARMACEUTICAL PACKAGING Slide 25 Key figures (FY 2008) SCHOTT Group  2.23 billion € sales worldwide  289 million € capital expenditures  Production plants and sales offices in 41 countries  17,300 employees (as of January 2009) Business Segment Pharmaceutical Packaging  260 million € sales worldwide  40 million € capital expenditures  3,100 employees SCHOTT pharmaceutical Packaging operates under the brand name SCHOTT forma vitrum
  26. 26. PHARMACEUTICAL PACKAGING Slide 26 Our Vision “We set performance standards in parenteral packaging.” Our Mission Future-oriented and committed to be the leading supplier of innovative parenteral packaging as well as a creative solution provider for drug delivery systems worldwide. As innovators we are setting standards with respect to quality, technology, and service. Our units operate in a GMP environment. Reliability and security of supply worldwide are our strengths. Dedicated customer orientation, entrepreneurial initiative, and continuous improvement at all levels make us a reliable partner for the pharmaceutical industry in a dynamically changing environment.
  27. 27. PHARMACEUTICAL PACKAGING Slide 27 SCHOTT forma vitrum offers pre-fillable syringes made of glass and COC* polymer  Completely sterile syringe set  Ready for the filling process  Available with luer cone, luer lock, and staked needle  Designed for bulk production, non-sterile  Available with staked needle, luer lock, or luer cone  Unassembled glass barrels, packed in rondo trays  Syringes available with integrated luer lock  Automated assembly technology with in line process control  Precision molding  Clean room packaging  DMF 18416 forma 3s® made of glass SCHOTT TopPac® Syringes made of COC polymer forma 2s made of glass *COC = Cyclo olefin co-polymer
  28. 28. PHARMACEUTICAL PACKAGING Slide 28 Worldwide presence France Technology Center Indonesia USA Colombia Brazil Mexico Hungary Switzerland Germany China India  Committed to growth and high standards  600 production lines worldwide  Extensive know-how exchange within group
  29. 29. PHARMACEUTICAL PACKAGING Slide 29 Quality – our key to success  Production processes in GMP environment  Statistical process control & advanced opto-electronic measuring systems  Compliance with the international standards EP, USP, JP; certification to ISO 9001, ISO 13485, and ISO 15378  Continuous training of our employees  Continuous improvement at all levels to achieve zero defects
  30. 30. PHARMACEUTICAL PACKAGING Slide 30 TopLineTopLine products are individually designed to meet advanced product requirements according to customer specifications. Enabling you to stay always one step ahead. Tailor-made solutions for the highest requirementsTailor-made solutions for the highest requirements Product lines by SCHOTT forma vitrum – industry quality leader all products according to USP, EP, JP ClearLineSCHOTT forma vitrum exclusive forming technology and 100 % dimensional and cosmetic inspection ensure an excellent production performance on your filling lines. Advanced product solutions for superior demandsAdvanced product solutions for superior demands StandardLineThe SCHOTT forma vitrum StandardLine is our well established high-level quality complying with international standards. High quality complying with international standardsHigh quality complying with international standards
  31. 31. © SCHOTT KAISHA Slide 31PPA/KSD,BA March 2009 for the opportunity to feel this vision, to share it and to achieve it – with you - day after day THANK YOUTHANK YOU SCHOTT forma vitrum and SCHOTT KAISHA – Your partners in growth
  32. 32. © SCHOTT KAISHA Slide 32PPA/KSD,BA March 2009 BACK UP
  33. 33. © SCHOTT KAISHA Slide 33PPA/KSD,BA March 2009 SCHOTT KAISHA organization chart Managing Director Kairus Dadachanji Director Operations Zorawar singh Rathore CFO Ajay Jain GM Exports Milton Fernandes GM India Sales & Marketing Mohan Gopal GM Admin. Gev Karai GM Finance Rohit Sarmalkar GM HR Gev Karai Purchasing Prasad Menon GM Ampoules Chandan Bhosle GM Vials Ajit Kumar GM DC & PFS Rahul Dev AGM Greenfield Project Anil Nair Marketing Executive Vijayeta Bhambhani Regional Manager N.India Sanjay Mehta GM Supply Chain Rajesh Pillai GM Admin and Regulatory Mr. Anand Nair GM Unit III Prasad Menon Product Manager PFS Ramesh Kawale
  34. 34. © SCHOTT KAISHA Slide 34PPA/KSD,BA March 2009 PFS - technical specifications 1/2, 5/8,18.6510.8535.7standard1.0 ml 1/2, 5/84.656.8547.60.5 ml NeedleIDODHeightmlBulk Syringes with needles Bulk Syringes Luercone/Luerlock 11.8514.4566.75.0 ml 8.6510.8554.42.25 ml 8.6510.8535.7standard1.0 ml 4.656.8547.60.5 ml IDODHeightml
  35. 35. © SCHOTT KAISHA Slide 35PPA/KSD,BA March 2009 Safepac™ Syringe Systems Luer Tip 11.8514.4566.75.0 ml 8.6510.8554.42.25 ml 8.6510.8535.7standard1.0 ml 4.656.8547.60.5 ml IDODHeightmlSafepac™ Syringe Systems Luerlock 11.8514.4566.75.0 ml 8.6510.8554.42.25 ml 8.6510.8543.2standard1.5 ml 8.6510.8535.71.0 ml IDODHeightml PFS - technical specifications
  36. 36. © SCHOTT KAISHA Slide 36PPA/KSD,BA March 2009 ml Height OD ID Needle 0.5 ml 47.6 6.85 4.65 1/2 1.0 ml standard 35.7 10.85 8.65 1/2, 5.8, 1 1.5 ml 43.2 10.85 8.65 1/2, 5.8, 1 Safepac™ Syringe Systems with needles PFS - technical specifications
  37. 37. © SCHOTT KAISHA Slide 37PPA/KSD,BA March 2009 Close co-operation with contract filling facility offers a „one stop shop“ to customers
  38. 38. © SCHOTT KAISHA Slide 38PPA/KSD,BA March 2009 Sovereign facility layout – ground floor