Presentation belongs to schott kaisha pvt. ltd. designed by Ace Interactives

1. © SCHOTT KAISHA
SCHOTT KAISHA
OPPI

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. © 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. © 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. 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. 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. 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. 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. © 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. © 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. © 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. © 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. © 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. © 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. © 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. © 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. © SCHOTT KAISHA

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. © 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. © 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. © 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. PHARMACEUTICAL PACKAGING
Slide 22
Introduction to SCHOTT

23. PHARMACEUTICAL PACKAGING
Slide 23
Home Tech
The SCHOTT Group
Pharmaceutical
Systems
Electronic
Packaging
Solar
Advanced
Materials
Flat Glass Fiber Optics

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. 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. 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. 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. 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. 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. 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. © 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. © SCHOTT KAISHA
Slide 32PPA/KSD,BA March 2009
BACK UP

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. © 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. © 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. © 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. © SCHOTT KAISHA
Slide 37PPA/KSD,BA March 2009
Close co-operation with contract filling facility offers a
„one stop shop“ to customers

38. © SCHOTT KAISHA
Slide 38PPA/KSD,BA March 2009
Sovereign facility layout – ground floor