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BUILDING AN INTEGRATED COMPANY

     Research             Manufacturing
                                      g          Packaging
                                                      g g
• Pre-clinical studies   • Intermediates     • Finished
• API                    • Actives             Pharmaceuticals
• Formulation            • Finished dosage
                               s e osage
  Development




                                               … Caring for Relationships
Vision:
 • We aim at earning the reputation of being a reliable manufacturer and a force to reckon with in the area
   of Production of Chemical Intermediates, Bulk Actives and Pharmaceutical Formulations.
 • We aim at being considered a benchmark when it comes to Production efficiency & excellence across
   the Globe
 • We see ourselves in the future as having a diverse portfolio of customers and contributing to their
   success

Mission:
 • While Aligning all short and long term strategies with our ‘vision’ we shall :
 • Put our best foot forward in our R&D efforts to develop important generic alternatives for new drugs.
 • Create an operations environment that balances key objectives, quality and costs with a resultant
   outcome that gives us the competitive advantage.
                                         advantage
 • Delivering superior customer service and shareholder value.
 • “We dedicate ourselves to the pursuit of: “Providing a respectful and rewarding work environment for
   our employees”
Savita Gowda - Managing Director
• Over 18 years experience in manufacturing and marketing & SCM
• Overseas overall operations of the Company
• Main focus on Strategy and Commercial Operations

Lalit Misra - Director
• Over 14 years in Operations, Projects & Business Development
          y         p         , j                        p
• Responsible for Operations, Business Development and New Projects.



Mohan K l Director
M h Kala - Di t
• 28 years of financial operations in Pharma Industry
• Responsible for the Finance, Costing and Taxation matters



Vijay Kriplani – Director
· 29 years of experience in Designing, Executing & Engineering of Projects, Product
Development, Technology development, Feasibility Study of the Projects.
Responsible for Executing of Projects, Technology Development
Established in 1989. Current management took over in 1995.


Public Listed, with shares traded at the Bombay Stock Exchange.


Annual turnover of over $130 mn


Operations spanning across 7 locations in India


Market Presence in more than 40 countries.


Facilities are approved by Several International Health Authority.
2011                     GLP OECD received for Sa-Ford
                                                                               Canadian Approval received for Formulation Unit 1.
                                                                               Finished Product Supplies to Australia started


                                            2010                  Certification for Formulation Unit & API
                                                                  - GMP accreditation by UKMHRA for Formulation Unit 1.
                                                                  -WHO GMP certified for API Unit 2.
                                       2009
                                                            Foray in Animal Toxicology
                                                            Commissioned API Unit – 2 with focus on regulated markets.

                                2007                  Commissioned Formulation Unit at Dehradun.


                         2005
                                                Awarded ISO 9001-2000 accreditation by BVQI UKAS –API Unit-I.

                    2000
             1997                       Went public with 25% offering focus on R&D in API / Int.
1989 1995
                                Foray into API’s with Launch of Trimetazidine Di HCl

                     Current Management took over.

    Incorporation of Company.
2014                   Proposed Formulation Facility in SEZ Vizag, India.
                                                      Projected Investment 50 m USD




                     2013                 Proposed API Facility in Sh l
                                          P       d     F ilit i Sholapur, M h ht
                                                                           Maharashtra.
                                          Projected Investment 30 m USD




              2012             EMEA & US FDA Approvals for API Unit 2


       2012
                        US FDA & MCC S h Af A
                                     South Africa Approvals f F
                                                         l for Formulation U 1
                                                                    l      Unit

2012
               Joint Venture Project for API Manufacturing in Uzbekistan
Turnover in USD millions                                                               133
                                                                                                                                       EPS
                                                                        111                                                                        29.64
                                      94
        75                                                                                                                              17.73
                                                                                                                            17.62




    07 08
    07-08                           08 09
                                    08-09                               09 10
                                                                        09-10                         10 11
                                                                                                      10-11                 08-09      09-10       10-11




                                                                                                                                    Share Holder
             Sharon Vs Sensex                                                              Sensex
                                                                                           Sharon
21000                                                                                                                 200
20500                                                                                                                 190
20000
                                                                                                                      180
19500
19000                                                                                                                 170
18500                                                                                                                 160
18000                                                                                                                 150
17500
                                                                                                                      140
17000
16500                                                                                                                 130
16000                                                                                                                 120
             10
                      10
                               10
                                        10
                                                 10


                                                                   11
                                                                             11




                                                                                                        11
                                                                                                                 11
                                                          10




                                                                                      11
                                                                                               11
         Jul-1
                  Aug-1




                                             Nov-1




                                                                                                    May-1
                           Sep-1
                                    Oct-1


                                                      Dec-1
                                                               Jan-1
                                                                         Feb-1
                                                                                  Mar-1
                                                                                           Apr-1


                                                                                                             Jun-1
Location: Taloja, Mumbai
              j ,
 Separate High pressure reaction zone.
 Specialization of handling 5 to 6 development projects simultaneously.
 Focused on Development of cost effective, quality products
             De elopment         effecti e ualit products,
  Process Improvement & simplification.
 cGMP – Kilo Lab Facility

Analytical Method Development team
well supported by:
 HPLC’s, UV visible spectrophotometer, GC
  HPLC s,
 FTIR
 Purified water generator
 3 Stability Ch b
    S bili Chambers
 Misc testing instruments / apparatus
Research & Development : Formulation
Location: Dehradun & Mumbai

 Two separate development sites at Dehradun & Mumbai.

 Focused on development of Oral solid dosage; Tablet & Capsules.

 Specialization in development of Sustained Release & Bi-layered products.

 In house analytical laboratory to support Method Development, Validation & Stability Analysis.

 Tie-ups with External Labs for performing of Clinical studies.
Location: Taloja, Mumbai.
              j ,
 Certification: WHO GMP, ISO 9001-2008, GMP
 Countries for which approval is proposed: South Korea, Europe, GCC Countries, USA, Mexico.

Manufacturing:
Over 60 Reaction/processing vessels with total capacity over 1 Lakh ltrs.

Powder handling Capacity up to 4 MT finished product per day.

API Unit 1 f
     U it focused on M f t i of I t
                d Manufacturing f Intermediates.
                                         di t
API Unit 2 is a Start-of-Art cGMP Facility commissioned in 2009 mainly focused on API’s.

API Unit 2 has 3 Manufacturing lines & Packaging lines capable of handling 1Kg to 500Kg batch sizes.
Fluid Bed Dryer




  Reaction area


Isolation Vessel
                                             Blender
                   Vacuum Tray Dryer
FTIR
               Wet Lab
                                     HPLC
GC Room   Chemical & Reagent Store
Location: Dehradun, near Delhi
                  ,
 Certification / Approvals:
   UKMHRA, WHO GMP , INVIMA, (Colombia), Namibia, Uganda, TGA, Canada.
 Proposed Certification: USFDA & ANVISA
           Certification

Manufacturing:
 Capacity Tablets & Capsules
   CURRENT              : 2500 million
   POST EXPANSION : 4500 million
 The plant has capability to manufacture Solid oral dosage forms Aqueous Non aqueous as well
                                                            forms, Aqueous, Non-aqueous
   as temperature/humidity sensitive products .
 Plant is well equipped with 5 Wet Granulation Suites, 2 Dry Granulation suite, 6
   Compression, suites, 2 Capsulation suites and 9 Packaging Suites.
      p       ,       ,     p                           g g        .
Granulation




                       Pelletisation

Tablet Compression




                     Tablet Coating

Blister Packaging




                     Bulk Packaging
Sharon has strategically tied up with third party Manufacturing sites for the below mentioned
Categories. All these sites have WHO GMP Certification.

 Oncology : Capable of handling cytotoxic & Non- cytotoxic products. Also
  capable of manufacturing Lyophilized products.

 Cephalosporin range: Capable of manufacturing Tablets, Capsules & Injectable including Dry
                                                Tablets
powder injection

 Injectable: Capable of handling Non B-lactum & Non-cephalosporin Injectable.
 Also capable of manufacturing Ophthalmic range of products.

 Ointments & Creams: Capable of handling a wide range of products.

 Soft Gel: Capable of handling a wide range of herbal products
 Location: Taloja, Mumbai.
  L ti T l j M b i
 Quality Standards: OECD GLP (Certificate No.: GLP/C 0033), EPA, ICH, ISO
  10993

    Operating as SA-FORD, which is a division of Sharon Bio Medicine Ltd.

    SA-FORD stands for SAnctuary FOr Research & Development and is Sharon’s
                                     y                         p
     initiative towards building a Contract Research Organization of high repute.

    SA-FORD offers short & long term studies on mice, rodents , g
                               g                                 guinea pigs and
                                                                          g
     rabbits.

    Studies offered include Inhalation, Reproductive Toxicology & Genotox

    Expansion is underway to add a dog facility
Double Door
                        Autoclaves
                             l
Animal Cage




Clinical Chemistry
                 y   Histopathology
                          p      gy
CQA:
 The Corporate Quality Assurance (CQA) team based at the Vashi office, keeps an overview on
  ensures that high levels of Quality standards are followed at all manufacturing sites.
 With over 12 personnel the team is well equipped and directly controls the various Site specific
  Quality Teams.
 The CQA reports directly to the Management.
 The CQA has its own quality audit systems whereby it is able to determine any compliances at
  manufacturing site.

RA:
 The Regulatory Affairs (RA) team based at the Vashi office, coordinates with all sites for
  Technical Documents to ensure that all Drug Master Files & Dossiers are processed as per the
  requirement.
 With over 10 people the RA team has sufficient expertise to handle and manage all queries
  from Customers and Regulatory Authorities worldwide.
» ADD SUSTAINABILITY TO YOUR SUPPLY CHAIN THROUGH INTEGRATED
  INTERMEDIATE, ACTIVE & FINSIHED DOSAGE MANUFACTURING.


» BENEFIT FROM OUR EXPERIENCE IN PRODUCTION PROJECT MANAGEMENT
                                 PRODUCTION,
  AND PRODUCT LIFE CYCLE MANAGEMENT


» BENEFIT FROM OUR HIGH LEVEL OF ‘COMMITMENTS
  WITH REGARDS TO QUALITY & DELIVERY
Company Overview - Sharon Bio-Medicine Ltd.

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Company Overview - Sharon Bio-Medicine Ltd.

  • 1.
  • 2. BUILDING AN INTEGRATED COMPANY Research Manufacturing g Packaging g g • Pre-clinical studies • Intermediates • Finished • API • Actives Pharmaceuticals • Formulation • Finished dosage s e osage Development … Caring for Relationships
  • 3. Vision: • We aim at earning the reputation of being a reliable manufacturer and a force to reckon with in the area of Production of Chemical Intermediates, Bulk Actives and Pharmaceutical Formulations. • We aim at being considered a benchmark when it comes to Production efficiency & excellence across the Globe • We see ourselves in the future as having a diverse portfolio of customers and contributing to their success Mission: • While Aligning all short and long term strategies with our ‘vision’ we shall : • Put our best foot forward in our R&D efforts to develop important generic alternatives for new drugs. • Create an operations environment that balances key objectives, quality and costs with a resultant outcome that gives us the competitive advantage. advantage • Delivering superior customer service and shareholder value. • “We dedicate ourselves to the pursuit of: “Providing a respectful and rewarding work environment for our employees”
  • 4. Savita Gowda - Managing Director • Over 18 years experience in manufacturing and marketing & SCM • Overseas overall operations of the Company • Main focus on Strategy and Commercial Operations Lalit Misra - Director • Over 14 years in Operations, Projects & Business Development y p , j p • Responsible for Operations, Business Development and New Projects. Mohan K l Director M h Kala - Di t • 28 years of financial operations in Pharma Industry • Responsible for the Finance, Costing and Taxation matters Vijay Kriplani – Director · 29 years of experience in Designing, Executing & Engineering of Projects, Product Development, Technology development, Feasibility Study of the Projects. Responsible for Executing of Projects, Technology Development
  • 5. Established in 1989. Current management took over in 1995. Public Listed, with shares traded at the Bombay Stock Exchange. Annual turnover of over $130 mn Operations spanning across 7 locations in India Market Presence in more than 40 countries. Facilities are approved by Several International Health Authority.
  • 6. 2011 GLP OECD received for Sa-Ford Canadian Approval received for Formulation Unit 1. Finished Product Supplies to Australia started 2010 Certification for Formulation Unit & API - GMP accreditation by UKMHRA for Formulation Unit 1. -WHO GMP certified for API Unit 2. 2009 Foray in Animal Toxicology Commissioned API Unit – 2 with focus on regulated markets. 2007 Commissioned Formulation Unit at Dehradun. 2005 Awarded ISO 9001-2000 accreditation by BVQI UKAS –API Unit-I. 2000 1997 Went public with 25% offering focus on R&D in API / Int. 1989 1995 Foray into API’s with Launch of Trimetazidine Di HCl Current Management took over. Incorporation of Company.
  • 7. 2014 Proposed Formulation Facility in SEZ Vizag, India. Projected Investment 50 m USD 2013 Proposed API Facility in Sh l P d F ilit i Sholapur, M h ht Maharashtra. Projected Investment 30 m USD 2012 EMEA & US FDA Approvals for API Unit 2 2012 US FDA & MCC S h Af A South Africa Approvals f F l for Formulation U 1 l Unit 2012 Joint Venture Project for API Manufacturing in Uzbekistan
  • 8. Turnover in USD millions 133 EPS 111 29.64 94 75 17.73 17.62 07 08 07-08 08 09 08-09 09 10 09-10 10 11 10-11 08-09 09-10 10-11 Share Holder Sharon Vs Sensex Sensex Sharon 21000 200 20500 190 20000 180 19500 19000 170 18500 160 18000 150 17500 140 17000 16500 130 16000 120 10 10 10 10 10 11 11 11 11 10 11 11 Jul-1 Aug-1 Nov-1 May-1 Sep-1 Oct-1 Dec-1 Jan-1 Feb-1 Mar-1 Apr-1 Jun-1
  • 9. Location: Taloja, Mumbai j ,  Separate High pressure reaction zone.  Specialization of handling 5 to 6 development projects simultaneously.  Focused on Development of cost effective, quality products De elopment effecti e ualit products, Process Improvement & simplification.  cGMP – Kilo Lab Facility Analytical Method Development team well supported by:  HPLC’s, UV visible spectrophotometer, GC HPLC s,  FTIR  Purified water generator  3 Stability Ch b S bili Chambers  Misc testing instruments / apparatus
  • 10. Research & Development : Formulation Location: Dehradun & Mumbai  Two separate development sites at Dehradun & Mumbai.  Focused on development of Oral solid dosage; Tablet & Capsules.  Specialization in development of Sustained Release & Bi-layered products.  In house analytical laboratory to support Method Development, Validation & Stability Analysis.  Tie-ups with External Labs for performing of Clinical studies.
  • 11. Location: Taloja, Mumbai. j ,  Certification: WHO GMP, ISO 9001-2008, GMP  Countries for which approval is proposed: South Korea, Europe, GCC Countries, USA, Mexico. Manufacturing: Over 60 Reaction/processing vessels with total capacity over 1 Lakh ltrs. Powder handling Capacity up to 4 MT finished product per day. API Unit 1 f U it focused on M f t i of I t d Manufacturing f Intermediates. di t API Unit 2 is a Start-of-Art cGMP Facility commissioned in 2009 mainly focused on API’s. API Unit 2 has 3 Manufacturing lines & Packaging lines capable of handling 1Kg to 500Kg batch sizes.
  • 12. Fluid Bed Dryer Reaction area Isolation Vessel Blender Vacuum Tray Dryer
  • 13. FTIR Wet Lab HPLC GC Room Chemical & Reagent Store
  • 14. Location: Dehradun, near Delhi ,  Certification / Approvals: UKMHRA, WHO GMP , INVIMA, (Colombia), Namibia, Uganda, TGA, Canada.  Proposed Certification: USFDA & ANVISA Certification Manufacturing:  Capacity Tablets & Capsules CURRENT : 2500 million POST EXPANSION : 4500 million  The plant has capability to manufacture Solid oral dosage forms Aqueous Non aqueous as well forms, Aqueous, Non-aqueous as temperature/humidity sensitive products .  Plant is well equipped with 5 Wet Granulation Suites, 2 Dry Granulation suite, 6 Compression, suites, 2 Capsulation suites and 9 Packaging Suites. p , , p g g .
  • 15. Granulation Pelletisation Tablet Compression Tablet Coating Blister Packaging Bulk Packaging
  • 16. Sharon has strategically tied up with third party Manufacturing sites for the below mentioned Categories. All these sites have WHO GMP Certification.  Oncology : Capable of handling cytotoxic & Non- cytotoxic products. Also capable of manufacturing Lyophilized products.  Cephalosporin range: Capable of manufacturing Tablets, Capsules & Injectable including Dry Tablets powder injection  Injectable: Capable of handling Non B-lactum & Non-cephalosporin Injectable. Also capable of manufacturing Ophthalmic range of products.  Ointments & Creams: Capable of handling a wide range of products.  Soft Gel: Capable of handling a wide range of herbal products
  • 17.  Location: Taloja, Mumbai. L ti T l j M b i  Quality Standards: OECD GLP (Certificate No.: GLP/C 0033), EPA, ICH, ISO 10993  Operating as SA-FORD, which is a division of Sharon Bio Medicine Ltd.  SA-FORD stands for SAnctuary FOr Research & Development and is Sharon’s y p initiative towards building a Contract Research Organization of high repute.  SA-FORD offers short & long term studies on mice, rodents , g g guinea pigs and g rabbits.  Studies offered include Inhalation, Reproductive Toxicology & Genotox  Expansion is underway to add a dog facility
  • 18. Double Door Autoclaves l Animal Cage Clinical Chemistry y Histopathology p gy
  • 19. CQA:  The Corporate Quality Assurance (CQA) team based at the Vashi office, keeps an overview on ensures that high levels of Quality standards are followed at all manufacturing sites.  With over 12 personnel the team is well equipped and directly controls the various Site specific Quality Teams.  The CQA reports directly to the Management.  The CQA has its own quality audit systems whereby it is able to determine any compliances at manufacturing site. RA:  The Regulatory Affairs (RA) team based at the Vashi office, coordinates with all sites for Technical Documents to ensure that all Drug Master Files & Dossiers are processed as per the requirement.  With over 10 people the RA team has sufficient expertise to handle and manage all queries from Customers and Regulatory Authorities worldwide.
  • 20. » ADD SUSTAINABILITY TO YOUR SUPPLY CHAIN THROUGH INTEGRATED INTERMEDIATE, ACTIVE & FINSIHED DOSAGE MANUFACTURING. » BENEFIT FROM OUR EXPERIENCE IN PRODUCTION PROJECT MANAGEMENT PRODUCTION, AND PRODUCT LIFE CYCLE MANAGEMENT » BENEFIT FROM OUR HIGH LEVEL OF ‘COMMITMENTS WITH REGARDS TO QUALITY & DELIVERY