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Delivering Detail Diligence Dedication in with and www.jubilantbiosys.com D The added Dimension in Drug Discovery Focus on: Contract Development and Manufacturing

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Page 1: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

Delivering

Detail

Diligence

Dedication

in

with

and

www.jubilantbiosys.com

D

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The added Dimensionin Drug Discovery

Focus on: Contract Development and Manufacturing

Page 2: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Jubilant Life Sciences

An integrated global Pharmaceutical & Life Sciences

● ‘Partner of Choice’ to global life sciences companies

● Low cost, multi location and vertically integrated supplier

● Strong relationships with 19 of top 20 Global Pharma companies & 7 of top 10 Global Agrochemical companies

● Among first few companies to be Responsible Care® 14001:2013 (RC 14001:2013) certified

40 Years

4 Decades of Rich Scientific Experience

6,700 Employees

● 1000 in R&D● 1400 in North America

11 Plants

Manufacturing Plants● 7 in India● 4 in North America

Page 3: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Jubilant Life Sciences - Business Segmentation

Jubilant Life Sciences US $895.6 Million

Specialty Pharmaceuticals-Injectables

● Radiopharmaceuticals

● CMO of Sterile Injectables

● Allergy Therapy Products

Generics

● Solid Dosage Formulations

● Active Pharmaceutical I Ingredients (APIs)

● India Branded Pharmaceuticals

Specialty Intermediates &Nutritional Products

Specialty Intermediates

● Advance Intermediates

● Fine Ingredients

● Crop Science Ingredients

Nutritional Products

● Vitamins

● Animal Nutrition

Life Science Chemicals

● Life Science Chemicals

● Ethanol and Specialty Gases

● Chemistry services (Synthetic chemistry, Medicinal chemistry, Analytical chemistry and Process research/GMP)

● Computational chemistry

● Discovery Informatics

● Drug Metabolism and Pharmacokinetics

● In vitro / vivo biology

● In vivo biology

● Integrated drug discovery

● Structural biology

● Toxicology (GLP and Non GLP)

Pharmaceuticals Life Science Ingredients Drug Discovery Solutions

Page 4: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Global Footprint

This illustration is not exhaustive. This illustration is not to scale.

Page 5: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Innovative PartnerShips Across The Value Chain

MedicinalChemistryMedicinalChemistry

ComputationalChemistry

ComputationalChemistry

StructualBiology

StructualBiology

DMPKServicesDMPK

Services

ToxicologyServices

ToxicologyServices

DISCOVERYDISCOVERY

DEVELOPMENTDEVELOPMENT

CustomSynthesisCustom

Synthesis

GLPAnalyticalServices

GLPAnalyticalServices

GMPManufacturing

GMPManufacturing

ProcessResearch &

Development

ProcessResearch &

Development

CMCDocumentation

CMCDocumentation

COMMERCIALIZATIONCOMMERCIALIZATION

ProcessCharacterization

& Validation

ProcessCharacterization

& Validation

RegulatoryStarting

Materials

RegulatoryStarting

Materials

APIsAPIs

AdvancedIntermediates

AdvancedIntermediates

ProcessIntensification

ProcessIntensification

● R&D Centers: Noida & Bangalore● 400+ Scientists

● Pilot Plants: Noida & Gajraula● Reactors: 20+● Reactor Volumes: 20L – 1KL● 50+ Scientists

● 9 Multi Purpose Plants for Non-GMP / GMP Intermediates & Actives● Reactors: 100+● Reactor Volumes: 1KL to 14KL

Drug Filing with Global Regulatory Authorities

TargetIdeation

Lead Generation

Lead Optimization

CandidateSelection

Target Validation

Pre-clinicalAnimal Safety

Clinical Ph I Ph II Ph III

APIs & Intermediates

Product Launch

Manufacture Marketing/Phase IV

Integrated Project Management

Page 6: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Discovery Services

Target to Lead Generation

● Structural Biology (Protein Science, X-ray, Crystallography)● Medicinal and Computational Chemistry● Screening & Profiling● Early ADMET & PK● In-vitro / In-vivo Pharmacology

Lead Optimization

● Medicinal Chemistry● DMPK● SBDD (Co-crystallization, Computational Modelling)● Target Engagement & Disease Models● Safety Profile (hERG, Nav 1.5)● Pre-formulation

Candidate Selection (IND)

● Process Chemistry cGMP● Scale-up & API● Genotox● Non-GLP Tox (rodent and dog*)● GLP Tox (rodent and dog*)● D2M predictions (WinNonlin)

Disease Biology Expertise

CNSMetabolic Disorder Pain & Inflammation (P&I)Oncology

Page 7: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Developmental Chemistry Services

● Scaffolds, Building blocks, Intermediates, Reference compounds

● Asymmetric synthesis (Stereo-selective, enzymatic and resolution techniques)

● Impurity / Metabolite synthesis.

● Speciality Chemistry at Small Scales like Nucleosides , Small Peptides, Carbohydrates , Steroids, Macromolecules.

● Route Scouting & development

● Process design, development and optimisation (CMC)

● Salt screening and polymorph studies

● Process safety studies

● GMP and Non-GMP Material supplies for Tox, Pre-clinical, Phase I / II.

● Process Intensification Lab with Micro & Plug Flow Reactor.

● GLP Method developments

● Purifications (including chiral compounds)

● Stability studies (ICH)

● Solid State characterizations (DSC, TGA, XRD)

● Impurity profiling

● In Process Quality Control

Custom Synthesis Process Research / GMP Analytical Research

Page 8: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Piloting Capabilities - Phase I and Phase II

End-to-end GMP production and processing of APIs / Final API for Animal tox / Phase- I / II Clinical material

● Manufacturing suites enabling 3 processes simultaneously

● Dedicated HVAC systems for each suite with single-pass air controls

● Dedicated Process areas, RM Store, Water system and FG Quarantine

● pH range 2 to 12 (Acidic & Basic)

● Reactor size 20- 100 L Glass / SS

● Wide range of process conditions for multi product manufacturing

● ISO-8 (Class 1,00,000) clean rooms for entire manufacturing operations

● Temperature, humidity & differential pressure controlled (Building Management System) areas Independent

● Batch size 500 g to ~10 kg

● Temperature range - 90 °C to 200 °C

Page 9: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Key Differentiators

● Technology & Product Integration 35 years of integration experience GLP compliant R&D facilities

● Global Reach & Strong Customer Base

Product exports to over 100 countries Business with top innovators across various industries

● Global Leadership

All products evaluated on their strength & potential to attain global leadership

● Responsible Care 14001 Certification

LSI business certified under the American Chemistry Council’s (ACC) Responsible Care® program for Corporate Office, Noida & Gajraula Manufacturing Unit

● Strict Quality & Regulatory Compliance

Dedicated regulatory Team ensures In-house technologies to be non-infringing and compliance to global regulatory norms

● Business Excellence

Implementation of Business Excellence initiatives across all business functions - Six Sigma, Lean, DFSS, TPM, EPM, Sankalp, WCM, SCORE, CRM & Stage Gate in all SBUs.

● Environmental Health & Safety

Strong EHS initiatives

Focus on Process and Behaviour based safety

Dedicated Occupational Health Centre

Zero discharge facility

Valid Hazardous waste authorization

● Green Manufacturing Practices

Use of Green raw materials (Corn / Cane Ethanol) for majority of products. Results in lower carbon footprint compared to petroleum based manufacturing

● Sustainability

Corporate Sustainability Reporting for over 10 years with Multiple GRI A+ ratings.

● EcoVadis

Registered with EcoVadis for CSR evaluation with a gold rating for Gajraula manufacturing unit placing Jubilant as one of the Top 5% companies globally.

● JUBILANT BHARTIA FOUNDATION

Reaching out to 91 villages, 4.5 lakh people and over 14,000 students through primary education, basic healthcare & livelihood generation

Page 10: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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Key Differentiators

● Technology & Product Integration 35 years of integration experience GLP compliant R&D facilities

● Global Reach & Strong Customer Base

Product exports to over 100 countries Business with top innovators across various industries

● Global Leadership

All products evaluated on their strength & potential to attain global leadership

● Responsible Care 14001 Certification

LSI business certified under the American Chemistry Council’s (ACC) Responsible Care® program for Corporate Office, Noida & Gajraula Manufacturing Unit

● Strict Quality & Regulatory Compliance

Dedicated regulatory Team ensures In-house technologies to be non-infringing and compliance to global regulatory norms

● Business Excellence

Implementation of Business Excellence initiatives across all business functions - Six Sigma, Lean, DFSS, TPM, EPM, Sankalp, WCM, SCORE, CRM & Stage Gate in all SBUs.

● Environmental Health & Safety

Strong EHS initiatives

Focus on Process and Behaviour based safety

Dedicated Occupational Health Centre

Zero discharge facility

Valid Hazardous waste authorization

● Green Manufacturing Practices

Use of Green raw materials (Corn / Cane Ethanol) for majority of products. Results in lower carbon footprint compared to petroleum based manufacturing

● Sustainability

Corporate Sustainability Reporting for over 10 years with Multiple GRI A+ ratings.

● EcoVadis

Registered with EcoVadis for CSR evaluation with a gold rating for Gajraula manufacturing unit placing Jubilant as one of the Top 5% companies globally.

● JUBILANT BHARTIA FOUNDATION

Reaching out to 91 villages, 4.5 lakh people and over 14,000 students through primary education, basic healthcare & livelihood generation

Page 11: Focus on: Contract Development and Manufacturing · Process Chemistry cGMP ... Macromolecules. ... compared to petroleum based manufacturing

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D The added Dimensionin Drug Discovery

Jubilant Biosys Limited

Bengaluru Research Site:

#96, Industrial Suburb 2nd Stage, Yeshwantpur Bangalore - 560 022 Karnataka India.

Tel: +91 80 66628400

Noida Research Site:

B-34, Sector 58, Noida, Uttar Pradesh 201301

Tel: +91 120 409 3300

For more information:[email protected]

Thank you for your time