WELCOME INNOVASSYNTH TECHNOLOGIES (INDIA) LIMITED - PowerPoint Presentation

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WELCOME

INNOVASSYNTH TECHNOLOGIES (INDIA) LIMITED

(An ISO-9001-2008 Company)

(A KNOWLEDGE BASED - R&D DRIVEN – CHEMICAL SERVICE COMPANY)

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CORPORATE PROFILE

CONFIDENTIAL - Not For Circulation

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Promoted by Raheja Group and Ghia GroupBoth the groups have interest in different business segments

Construction Material

Batteries

PublicationInsuranceChemicals Software

Have parternership with large multinational companies across

the world for many years

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BUSINESS IDEOLOGY

Innovassynth was formed in 2002 as a division of Futura Polysters Ltd. It became a separate company in 2004“Committed to Customer Satisfaction in Manufacturing of Value Added and Technology Intensive Products and Services by Employing Knowledge Based Human Resources.”

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INNOVASSYNTH BUSINESS AREAS

Contract ManufactureCustom Synthesis Contract Process ResearchFine Chemical Manufacture

We develop and produce products from gram to Kilo to Multi ton Levels

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OUR CORE VALUES

Customer satisfaction We regard it as a privilege to serve our customers. We make 100% customer satisfaction as our overriding priority.We see constructive criticism as an opportunity to improveWe maintain a professional work environment that communicates a dedication to excellence and quality.We set the highest standards and expectations for ourselves.

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THE SENIOR MANAGEMENT TEAM A PROFILE

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Mr. S.B. Ghia Chairman  After completion of his M.B.A. from the Bowling Green university, U.S.A. He is involved in running the Organisation since 1970. He is Chairman of Innovassynth Technologies (India) Ltd., Futura Polyesters Limited and Sonata Software Limited. He is also the Promoter of these Companies. In addition, he is on the board of directors of many other Indian companies.

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Dr. B. Sahu CEO & President  Doctorate in management from IISC Bangalore and Fellow in Management from Wharton Business School. More than 29 years of experience in various leading companies in India like TATAs, Indian Oil, Ashok Leyland and teaching assignment with leading Indian Management Institutes. Since 1985 he is with the group as a senior management team member at Corporate level. He has handled strategic assignments, Business Diversification and Management of change in the group. He is widely travelled and has more than 25 publications to his credit. He is also the executive director and president of Futura Polyesters Ltd.

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Dr. Balkrishna K. Kulkarni Director, R&D and Business Development and Chief Technology Officer  Qualification: Ph.D. Organic Chemistry (Organic Synthesis) No. Of Publications: 11  Work Experience: Hoechst India Ltd. 11 years in Drug Discovery and Process Research Targof Pure Drugs Ltd. 2 Years as Overall in-charge for Bulk Drug Manufacturing Unit Innovassynth Technologies (I) Ltd Joined in 1997; Mainly responsible for starting the "Custom Synthesis" activity. Also responsible for Commissioning and Establishing Production for Contract Manufacture in collaboration with BASF , Germany

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Mr. A Raghuveer;

Chief Finance Officer

Qualification:

CMA, MBA (Finance)

Work Experience:

He has 26+ Years experience in Pharmaceuticals and automobile industries

He has Worked in different capacities in companies like

Shasun

Pharmaceutical Ltd., AMCO

Saft

Ltd., Himalaya Drugs Co., Delphi Automotive Pvt. Ltd., PWC etc.

His expertise include Capital & Long Term Fund Management, Costing , Budgeting , MIS, improving internal controls etc

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Mr.

Dr. Vijay DhondgeVP- R&DMSc, 1988-90, (Organic Chemistry): S. P. College, University of Pune, PunePhD, 1991-1996 (Synthetic Organic Chemistry): National Chemical Laboratory, Organic Chemistry Technology Division, PunePost-Doctoral Fellow, Oct 1997-Sept 1998, National Taiwan University, Taipei, TaiwanWorked with Prof. Jim-Min Fang on design, synthesis and biological assay of novel Endothelin Receptor Antagonist.Post-Doctoral Fellow, Oct 1998 – Sept 1999, Ecole Polytechnique, Paris, FranceWorked with Prof. Joelle Prunet on total synthesis of Taxol, which is anticancer diterpene compound.Pharmaceutical professional with over 19+ years of experience in leading CRO/pharma companies (Wockhardt Research, TCG Life Sciences, Sai Life Sciences & Navin Fluorine) at various levels with demonstrated scientific and leadership contributions in managing business & operation of site  

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Mr. K Elumalai

Asst. Vice President

– ProductionQualification:He is B.Sc  chemistry from Chennai university , MBA , DCPIC, MA from Annamalai university.   Work Experience:He is exposure in USFDA, ISO14001, OHSAS 18001 , ISO -9001 ,  ISO 27001.He  has worked with Shasun  chemicals and drugs ltd more then  23 years  in bulk drug manufacturing, Quality testing,  planning, process  Optimization  & control. Standardizing  production target and  consumption norms.

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Mr. S. Rajendran, AVP – SUPPLY CHAINB.Sc., (Maths) Graduate from Madras University. Has a hands-on experience of 24+ years in handling entire supply chain activity in Stedman Pharmaceutical Private Limited. He has handled purchase of Raw materials, Packing Materials, Engineering items, Capex, Stationery, Office equipment, etc & all stores related activity.  His expertise includes handling of project related activity & Production Planning and Inventory Control (PPIC) and Costing of product. His versatility on various field of activities and experience helps him to handle men, money and material efficiently.

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Mr.

Somnath

SahooHead – Engineering & Facility PlanningHe has done BE (Mech.) with Hons from Utkal University and Diploma in Material management from NILM Chennai.He has about 20years of extensive experience in the field of engineering,project,energy saving schemes and EHS.He has worked with Century Rayon (BIRLA Group) and Indofil Industries (Modi group), forbes marshall, kirlosakr brothers ltd. to implement lot of energy project schemes and awarded more than 25 medals as best implementer in his previous organization.To his credit one of his best achievement is winning of RASHTRIYA VISWAKARMA PURSKAR from Hon’ble President of India for designing a heat exchanger implementing it to recover waste condensate in the year 2001. He is also a LEAD AUDITOR in EMS-14001 from TUV NORD India and has almost 12 years auditing skills in Standards like QMS/EMS/OHSAS .

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Dr. Mahesh V Sonar

Group Principal Scientist, R & D

He has done M.Sc. From North Maharashtra University, Jalgaon.

PhD from NCL Pune University, Pune.

Research Publications:

09

Oral/Poster/Conferences Presentations

: 10

Work Experience:

Four years of postdoctoral experience in the field of peptides and nucleic acids, which involves Peptide Nucleic Acid, Amide modified RNA and Peptide secondary structure from SUNY Binghamton, TJU Philadelphia and IISER Pune. Successfully develop fluorescence imaging of particular mRNA in cells and

tumors

. Developed chemical synthesis of various complex Organic Compounds, Peptides, PNA,

Glycopeptides

and Nucleic Acids. Extensive experience with NMR, CD, UV, IR, Raman, MALDI and fluorescence imaging. Experience with analytical/separation techniques, cellular assays/cellular uptake experiments, handling cancer cell lines.

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Dr. L.B.

Yadav

AVP. QC and Analytical Method development

He has done

Ph. D. in Chemistry from

Purvanchal

University.

He is over 24 year’s experience. In QC & QA areas. He worked with

Gujrat

Organics Ltd.,

Wanbury

Pharma

and

Chemspec

chemicals like big Companies.

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QUALITY POLICYIt is our endeavour to provide world class service in the areas of :01] Custom Synthesis02] Contract R & D03] Contract / Toll Manufactureto the pharmaceutical , drug discovery, fine & specialty chemicals industry.We follow ISO 9001 : 2008 Quality Management System and our focus is on continual improvement to Delight our customers by delivering quality product / services as per their requirement on time. Provide our employees with good working environment and modern manufacturing and R&D facilities. Enhance shareholders value, and be committed to community at large.

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ORGANOGRAM

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North by : B.M. Ghia Road and beyond that the Khopoli - Karjat Railway Track, followed by MUSCO Ltd. South by : Patalganga River.East by : Barren Land belonging to PEPCO Mills.West by : MUSCO Nallah and then Lowjee village

KHOPOLI PLANT

MUMBAI

SITE LOCATION

Innovassynth Technologies India limited

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NATIONAL HIGHWAY

MUMBAI CITY

INTERNATIONAL AIRPORT

NATIONAL CHEMICAL LAB

70KM

60KM

40KM

1 KM

80 KM

65 KM

SEA PORT

INDIAN INSTTITUE OF TECHNOLOGY

KHOPOLI

SATELLITE FACILITY

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CUSTOM

SYNTHESIS

TOLL MANUFACTURE

CONTRACTR&D

CONTRACT MANUFACTURE

SERVICES

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Business Segments

1. Pharma / Pharma Intermediates2. Protected Nucleosides & Amidites3. Protected Amino Acids for Peptide Synthesis4. Flavour & Fragrance Chemicals5. Fine & Specialty Chemicals6. Nutraceuticals

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DESCRIPTION

NUMBERSCEO & President1Production100R&D, ADL, QC & QA60Engg. & Maintenance27Finance/Accounts/IT15Supply Chain13HR , Admin & Safety11Total227

Man Power

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Technical Competencies

Sr. No.

QualificationNos.1Doctorates/Post docs72Post Graduates593Graduates984Diploma275Other certification36

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Area of land : 65 Acres. R&D Labs : 5 labs for 84 Chemists who can work on bench (2 for nucleosides, 2 for Organic Synthesis & 1 for Nutraceutical) Kilo Lab : 3 No. (2 for Nucleosides & 1 for other Organic Synthesis) Analytical method : 1 No. Development Lab QC Lab : 1 No.

Available Infrastructure at Khopoli

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Manufacturing Plants - 6 plants (including 2 exclusive plants for Nucleoside Products). Contract Manufacturing Plant for BASF Effluent Treatment Plant Dedicated Matching Utilities (e.g. Power (Generated & Purchased), Cooling Tower (for Chilled Water, Chilled Brine, DM Water), Nitrogen, Compressed Air, etc.) Boiler House Residential quarters : 100 nos. Guest Houses : 2 nos. Sport Clubs : 2 nos. cGMP Pilot Plant is commissioned in May 2009

Available Infrastructure at Khopoli

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Research & Development

Recognized by Dept of Scientific & Industrial Research (DSIR), Govt. of IndiaRecognized by Bombay University as Center for Post Graduate Research

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View of Chemistry Lab

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Process Capabilities - Nucleosides

Protection and deprotection of nucleoside compounds Transformation of U to C via triazolation process 5’-O-Acylations Selective 2’-O alkylations Fluorination Azidation and catalytic reduction to amino derivative Phosphitylation

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Process Capabilities - Small Molecules

Grignard reactionsHandling reactions on large scale involving 100s of kgs of MgSafety system to take care of handling of Grignards are developed Friedel-crafts reactionHandling large quantities of AlCl3 for this reactionThe acidic effluent is disposed in very safe and unique manner (It is used by large common effluent treatment plants in Industrial areas as a substitute to alum for coagulation) Boron Chemistry (Borates, Boronic Acids, Boron Mediated Asymmetric Synthesis) Developed processes for many boronic acids by cheaper methods

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Process Capabilities – Small Molecules

Cyanation (NaCN, KCN, CuCN)Developed complete facility for this reaction including handling, charging and disposal of effluent after destruction of cyanide residueSpecial precaution is taken while handling the cyanide and people are provided with all safety gadgets and trainingHalogenation (Aliphatic/Aromatic)This includes both liquid bromine handling as well as chlorine gas handling from big toners of 1 MTCatalytic Hydrogenation 30 Bar; 1500CWe handle all types of catalystsThe noble metal catalysts are collected after use and sent for recovery

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Process Capabilities- Small Molecules

Organometallic reactionsDeveloped skills to handle nBuLi in big cylinders of capacity 400 kgFull safety systems are developed for reactions involving nBuLiOptimized and scaled up processes for making Organometalic catalysts like zirconium complexes. Oxidations using Metal Oxides, H2O2, Per Acids, HypochloriteReductions Using Metal Hydrides, Nobel Metals, Ni, Na/ EtOH, Al Isopropoxide, Chemical Reductions Aromatic Fluorination, SulphonationCarbohydrate Chemistry

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Few examples of our process strength and scale up capability:

Sodium-β-glycerophosphate (g2p)Process development and scale up to ton level in 6 months Higher capacity was achieved in existing facility by improving process parametersSince this product is used in Pharma foarmulations and in cell cultures, it has a very high worldwide demand.Innovassynth was awarded by supplier excellence award 2009 by Life Technologies Inc., USA

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Isosulphan BlueThis is a dye used in diagnostics for cancer detection. The chemistry involves handling of hazardous reagents like 65% oleum, dichromate solution, etc. The purification process involves separating the product from inorganic salts. Received US patent for the process for this product.

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7-Bromoheptene: This is an intermediate for a Hep C drug in clinical trial Phase IIIThe product is manufactured regularly as per customer requirement in ton lot quantity.The reaction involves Grignard reaction. MetallocineThis is a high end catalyst Large scale reactions were carried out using 400 kg cylinders n-BuLi Used in PolymerizationsDeveloped and scaled up for an international company

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Multipurpose Plant -1 Features

1. Operating Temperature range - 40 to 1800 C2. Vacuum 0.5 mm Hg to 100 mm Hg.3. Filtration : Centrifuge, Nutsche, Stirred Nutsche, Sparkler4. Drying : Rotacons5. Chromatography Columns ( 10 Nos )6. Rotavaps ( 5 Nos )7. Dedicated Utilities8. Plc Based Process Control System from Allen Bradley.

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Main Equipments In Multipurpose Plant

& Kilo Lab ( Plant 1 )

Sr.No.DescriptionNos.150L Glass Reactor022100L Glass Reactor 033200L Glass Reactor024220L MSGL Reactor01 5500L MSGL Reactor0161000L MSGL Reactor0172000L MSGL Reactor01850L SS 316 Reactor029210L SS 316 Reactor0110500L SS 316 Reactor01111000L SS 316 Reactor02122000L SS 316 Reactor0213Centrifuge 36” SS 3160214Centrifuge 24’’SS 31601

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Main Equipments In Multipurpose Plant

& Kilo Lab ( PLANT 1 )

Sr.No.DescriptionNos.15Rotocone Drier 50L SS 3160216Nutsche Filter 100L SS 3160217Nutsche Filter 100L PP FRP0218Rotavap 20L 0419Rotavap 50L 012012” x 3 Mtr. SS 316 Columns022118” x 3 Mtr. SS 316 Columns022224” x 3 Mtr. SS 316 Columns02234” x 2 Mtr. Glass Column01249” x 3 Mtr. Glass Column0125High Vacuum Pump (1 Torr)0626Water Ring Vacuum Pump (50 Torr)0227Ejector (1 Water + Steam) 0128Deep Freezer 1240L02

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Utilities in Plant 1

Sr. No.

DescriptionDetails1Power285 KW connected Load2SteamAt 6.0 Kg/cm2At 3.5 Kg/cm2 1000 Kg/Hr3Chilled Water20 Tr, 80 C,  T 50 C4Chilled Brine10 Tr, (-)200 C /(-)400 C,  T 50 C5Cooling Water100 Tr, 320 C,  T 50 C6Hot Water1000 L Capacity Upto 1000 C7Demineralised Water5 M3/hr8Nitrogen (Located in pp3/4/5 and catering to this plant)75 nm3/hr, 6Kg/cm3, Dew Point At (-40°C )9Instrument AirDry Air, 6 Kg/cm2Dew Point at (-)400 C10Low Vacuum50 mmHg, 2 Units11High Vacuum0.5 Torr, 3 Units

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View of Plant 1

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View of Plant 1

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View of Plant 1

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View of Plant 1

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View of Plant 1 – Kilo Lab

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View of Plant 1

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Multipurpose Plant - 2

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Main Equipments in Multipurpose Plant 2

Sr. No.DescriptionNos.150L Glass Reactor012100L Glass Reactor 033200L Glass Reactor024160L MSGL Reactor01 5250L MSGL Reactor03 6500L MSGL Reactor0171000L MSGL Reactor02850L SS 316 Reactor019160L SS 316 Reactor0110250L SS 316 Reactor0111500L SS 316 Reactor02

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Sr. No.DescriptionNos.121000L SS 316 Reactor01131500L SS 316 Reactor0114Rotocone Drier 200L SS 3160215Nutsche Filter 100L SS 3160216Nutsche Filter 100L PP FRP0117Rotavap 20L 0418Rotavap 50L 0119High Vacuum Pump (1 Torr)0320High Vacuum Pump (0.5 Torr)0321Ejector (1 Water + 2 Steam) 0222Deep Freezer 1240L01

Main Equipments in Multipurpose Plant 2

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Sr. No.DescriptionDetails1Power415 V, Ac, 50 Hz and 500 Kw connected Load2SteamAt 6.0 Kg/cm2At 3.5 Kg/cm2 1000 Kg/Hr3Chilled Water31 Tr, 80 C,  T 50 C4Chilled Brine10 Tr, (-)400 C,  T 50 C5Cooling Water150 Tr, 320 C,  T 50 C6Process WaterFiltered Water 8 M3/hr7Demineralised Water1 M3/hr, 1 mho Conductivity, with UV and HEPA filter suitable for GMP std.8Nitrogen6 Kg/cm3, Dew Point At (-)400 C9Instrument AirDry Air, 6 Kg/cm2Dew Point at (-)400 C10Low Vacuum20 mmHg, 150 Nm3/hr11High Vacuum2 Steam + 1 Water Ejector System, 1 Torr, 5 Nm3/hr

List of Utilities in Multipurpose Plant 2

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Main Equipments in Multipurpose Plant 3, 4 & 5

Sr. NoDESCRIPTION01500 Liters MSGL Reactor (2 No)021000 Liters MSGL Reactor (1 No) 032000 Liters MSGL Reactor (1 No)043000 Liters MSGL Reactor (1 No)05350 Liters SS-316 L Reactor (1 No)06500 Liters SS-316 L Reactor (4 No)071000 Liters SS-316 L Reactor (2 No)081500 Liters SS-316 L Reactor (3 No)092000 Liters SS-316 L Reactor (2 No) 102500 Liters SS-316 L Reactor (1 No)113000 Liters SS-316 L Reactor (3 No)126000 Liters SS-316 L Reactor (1 No)1310000 Liters SS-316 L Reactor (1 No)

Continued

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SR. NO

DESCRIPTION

14

4 Nos. Of Chromatography Columns

Total Silica Loading Capacity 800 Kg

15

250 L SS Rotocone Dryer (1 No)

16

400 L SS Rotocone Dryer (1 No)

17

500 L SS Rotocone Dryer (1 No)

18

600 L SS Rotocone Dryer (1 No)

19

2000 L SS Rotocone Dryer (1 No)

20

500 L SS-316 Tray Dryer (1 No)

21

40” SS-316 Centrifuge (1 No)

22

48” SS-316 Centrifuge (1 No)

23

60” SS-316 Centrifuge (1 No)

24

0.75 M2 SS-316 Open Nutch Filter (1 No)

25

1 M2 SS-316 Open Nutch Filter (1 No)

26

1.5 M2 SS-316 Open Nutch Filter (1 No)

27

2 M2 SS-316 Open Nutch Filter (1 No)

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SR.NODESCRIPTION013000 Liters MSGL Reactor (1 No)021000 Liters SS-316 Reactor (2 No)031200 Liters SS-316 Reactor (1 No)043500 Liters SS-316 Reactor (1 No)05Centrifuge SS-316 - 60 inches ( 1 No )06Pressurised Nutsche Filter SS-316 - 2 Sq. Mtr ( 2 No )07Distillation Column with Condenser System ( 8 mtr height ) ( 1 No )08Open Nutsche Filter PP/FRP – 2 Sq. mtr ( 1 No )09Milling Machine with conveyer – 50 Kg / hr SS-316 ( 1 No )

Main

Equipments in Multipurpose Plant 6

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Utilities

DESCRIPTIONCAPACITY01Cooling water600TR with operating temperature of 320 C & ΔT of 30 C 02Chilled water75TR with operating temperature of 80 C & ΔT of 30 C 03Chilled Brine 66TR with operating temperature of (-)200 C & ΔT of 30 C 04Steam3.5 Kg / cm2 (g) with 2500 Kg / Hr6.0 Kg / cm2 (g) with 0600 Kg / Hr05Nitrogen3.5 Kg/cm2 (g) 100 mm WC for blanketingOxygen content less than 1% & dew point (-)600 C06Instrument Air5.5 Kg / cm2 (g) Dew point (-)400 C07Process Water10 M3 / Hr08Demineralized Water50 M3/ day, Conductivity less than 5 Micro semen 09Hot Water SystemFor separate section from the range of 50c to 900c

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Electrical

Instrumentation

Allan – Bradley SystemHybrid system (Combination of DCS & PLC )Digital I/O200Analog I/O200FeaturesSequential functional chartSafety interlocks, Individual password protection History record capacity for a monthBatch sheet record & generation facilityEmergency trip sequence

Power450 V, AC, 50 Hz with the connected load of 1150 KWDiesel power450 V, with the back of 750 KW

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View of Plants 3,4 & 5 – 2

nd

Floor

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View of Plants 3,4 & 5 – 3

rd

Floor

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View of Plants 6

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HYDROGENATION / HIGH PRESSURE REACTIONS

Pilot Scale Autoclaves : 50 and 250 Ltr SS Temprature Range : -20 to 1700 C Pressure : Upto 30 Kg

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Contract Manufacturing Facility

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FDA FDA license from Indian govt to manufacture API (Hexyl resorcinol)DMF for Hexyl Resorcinol submitted to EDQMDocumentation provided to Sigma-Aldrich to file DMF for a product manufactured by Innovassynth for them on exclusive basis.ISOISO 9001-2008 certified by BVQI since year 2003. Half-yearly audits by BVQISupported by half-yearly internal auditsAudits from other clients:Facility audited by various companies (Drug discovery, Pharmaceuticals, Oligonucleotide manufacturing, Chemical, Catalogue

Regulatory Systems

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We abide by 2005 IPR actAll the controlled documents are kept with authorized personsCDA with all the employeesAll communications archivedUsage of external devices controlledControlled information access through intranet

IP Structure & Control

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1. The company follows ISO 9001 – 2008 quality system

2. Documentation is in line with

cGMP to fulfil the needs of regulatory activities of our customers such as DMF filing, etc3. SOPs, change process/equipment documentation, cleaning SOPs in place4. Current production activity as per applicable GMP5. Audited and Approved by many companies from US & Europe.

QA

System

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We have a team of chemists and senior scientists and communication systems to ensure highest quality analytical techniquesInnovassynth analytical & quality control department has more than 17 chemists/ scientists across the two departments and services include:Analytical Method DevelopmentAnalytical Method ValidationAnalytical method transferChemical TestingImpurity ProfileMicrobiological Testing Stability testing

Analytical capability

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Site Responsibilities

Supply Chain: Procurement of RM and Dispatch & logistics of finished products QC: Inspection of RM, In process, Intermediates and Finished products, Analytical Method Validation & Stability StudyQA: Monitor and maintain Quality Management Systems in line with ISO & applicable GMPR&D: Development & improvement of process, scale up and process transferManufacturing: Manufacturing & documentation of products according to specification following LPD and safety measures and process validationEngineering & EHS: Support manufacturing and other departments (Procurement, installations, maintenance and documentation)

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OUR PRIME CONCERNS

Safety , Health and Environment

SAFETY:

Audits (Internal/ External)HazopsDisaster Control PlanTraining, Awareness Programs

HEALTH:Regular Employee Health Monitoring

ENVIRONMENT:Comprehensive Liquid ETP (Cap: 1400m3 Per Day)Scrubbers / Stacks for gaseous effluentsAccess to Incineration / Landfill

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Innovassynth Team

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PHILOSOPHY OF BUSINESS RELATIONSHIP

COMMITMENT TO DELIVER ANDDELIVER THE COMMITMENT

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Responsible Organization (Environment/Safety) Knowledge Based and Empowered Employees Excellent Employee relations Integrated Site with R & D, Production and Backup facilities at one complex R&D Department recognized by Department of Science and Technology, Govt. of India Interface with the best Chemistry R&D Institutes in India & abroad. Exports to Europe, USA and Japan. Quality System as per ISO 9001:2008

WHY INNOVASSYNTH ?

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