Oppi presentation

© SCHOTT KAISHA

SCHOTT KAISHA OPPI

© 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

© 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

© 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

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 from1 ml to 100 ml

With or without blowback Special designs for

lyophilization Dual-chamber

(“mixer”) vials Screw neck vials

Vials made of glass

Cartridgesmade of glass

SCHOTT TopPac® Vialsmade of COC polymer

Ampoulesmade 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


Coated vials for sensitive drugs and vials for special applications

Containers with a quartz-like inner surface for improved chemical stability andinertness

Particularly suited for bio-pharmaceutical products withadsorption tendencies, highpH values, susceptibility to ashift in pH value, sensitivityto traces of metal ions, complexing agents like

EDTA, citrates

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®



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



Slide 8

SCHOTT forma vitrum - setting performance standards in parenteral packaging

MATERIALS MATERIAL IALS MATERIALS MATETERIALS MATERIALS M PRODUCTS PRODUCTSTS PRODUCTS PRODUCPRODUCTS PRODUCTSTECHNOLOGY TECHNONTECHNOLOGY TECHN LOGY TECHNOOLOGYT

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.

© SCHOTT KAISHA

Investment, Long term commitment & accreditation (1)

Investments in Mio.INR

424

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

© SCHOTT KAISHA


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

© SCHOTT KAISHA


ISO 9001: 2000 certification and DMF is available for all productsISO 9001: 2000 certification and DMF is available for all products


© SCHOTT KAISHA


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.Ranbax

y

© SCHOTT KAISHA


Exports to over 30 countries

Guatemala Senegal

UK Russia

Australia

Egypt

Uzbekistan

S AfricaNew Zealand

Dubai

Nigeria

GhanaZambia

Syria

Malaysia

Mexico

France

KenyaIndonesia

Bangladesh

Sweden

Israel

Costa Rica

Philippines

Ethiopia

Chile

USA Italy

Yemen

S.Korea

© SCHOTT KAISHA


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

© SCHOTT KAISHA


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

© SCHOTT KAISHA

Adherence to Environment, Health and SafetyCommitted 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

© SCHOTT KAISHA


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

© SCHOTT KAISHA


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

© SCHOTT KAISHA


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

© SCHOTT KAISHA


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.


Slide 22

Introduction to SCHOTT


Slide 23

Home Tech

The SCHOTT Group

Pharmaceutical Systems

ElectronicPackaging

Solar

AdvancedMaterials

Flat Glass Fiber Optics


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


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


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.


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 glassSCHOTT TopPac® Syringesmade of COC polymer

forma 2smade of glass

*COC = Cyclo olefin co-polymer


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


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


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

© SCHOTT KAISHA


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

© SCHOTT KAISHA


SCHOTT KAISHA organization chartManaging Director

Kairus Dadachanji

Director Operations

Zorawar singh Rathore

CFO

Ajay Jain

GMExports

Milton Fernandes

GM

India Sales & Marketing

Mohan Gopal

GM

Admin.

Gev Karai

GMFinance

Rohit Sarmalkar

GMHR

Gev Karai

Purchasing

Prasad Menon

GMAmpoules

Chandan Bhosle

GMVials

Ajit Kumar

GMDC & PFSRahul Dev

AGMGreenfield

Project

Anil Nair

Marketing ExecutiveVijayeta

Bhambhani

RegionalManagerN.India

Sanjay Mehta

GMSupply Chain

Rajesh Pillai

GM Admin andRegulatory

Mr. Anand Nair

GM Unit III

Prasad Menon

Product Manager PFS

Ramesh Kawale

© SCHOTT KAISHA


PFS - technical specifications

1/2, 5/8,18.6510.8535.7standard1.0 ml

1/2, 5/84.656.8547.6 0.5 ml

NeedleIDODHeight ml Bulk Syringes with needles

Bulk Syringes Luercone/Luerlock

11.8514.4566.7 5.0 ml

8.6510.8554.4 2.25 ml

8.6510.8535.7standard1.0 ml

4.656.8547.6 0.5 ml

IDODHeight ml

© SCHOTT KAISHA


Safepac™ Syringe Systems Luer Tip

11.85 14.4566.7 5.0 ml

8.6510.8554.4 2.25 ml

8.6510.8535.7standard1.0 ml

4.656.8547.6 0.5 ml

IDODHeight mlSafepac™ Syringe Systems Luerlock

11.85 14.4566.7 5.0 ml

8.6510.8554.4 2.25 ml

8.6510.8543.2standard1.5 ml

8.6510.8535.7 1.0 ml

IDODHeight ml


© SCHOTT KAISHA


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


Oppi presentation

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