Suven Life Sciences Limited · NSE:SUVEN
Suven Life Sciences — Investor Presentation (July 2016)
36 slides from Suven Life Sciences's investor presentation, July 2016
Slide 1: A Treasure House of Innovations and Excellence
A Treasure House of Innovations and Excellence
Slide 2: Company Overview
Company Overview Established in 1989 Profitable and dividend paying since listing in 1995 on the NSE and BSE Established presence across Contract Research and Manufacturing Services (CRAMS) - Leader and Innovator for NCE based Intermediates Drug Discovery – Focused on CNS segment World-cla
Slide 3: Suven's Business Model
SUVEN’S BUSINESS MODEL Drug Discovery Drug Product Delivery Formulation Clinical Chem lib / Lead Lead Clinical Development, Supplies identification / Pre Trial Process Custom comb chem hits Optimization Clinical Research Synthesis Analytical & Manufacturing characterization Supplies Regulatory & Pac
Slide 4: Of Pharmaceutical Relationship
Of Pharmaceutical Relationship CRAMS •Leader and Innovator for many NCE based intermediates •600+ projects •380+ R&D professionals DDDSS •Generic API’s •Leader in CNS based internal discovery in India •State of the art facility, models •Multiple big Pharma FORMULATIONS relationships •Pharmaceutical
Slide 5: Financials
Financials Year Ending March '31 2015 2014 Million (Rs) Million (Rs) Income 5,188.73 5,294.36 Pre-R&D EBITDA 2,055.55 2,250.02 Pre-R&D EBITDA Margin 39.62% 42.50% EBITDA 1,426.04 1,680.40 EBITDA Margin 27.48% 31.74% EBIT 1,258.83 1,562.64 EBIT Margin 24.26% 29.52% Financing Costs 54.17 47.09 Taxes 2
Slide 6: Suven Formulation Development Centre
SUVEN Life Sciences For wlatioi Development Centire
Slide 7: Capabilities Overview
CAPABILITIES OVERVIEW 110,000+ sq. ft of World-class Infrastructure comprising • Analytical Method Development & Validation Laboratories • Dissolution Testing Laboratory • Wet Chemistry Laboratory • Microbiology Testing Laboratory • Stability Chambers (220,000 L) • Formulation Development Laboratori
Slide 8: FDC Services
FDC Services Formulation Development Centre -a Natural extension to the existing CRAMS Business Formulation Development NCE’s ANDA’s NDA’s (Differentiated Products) OTC Analytical Development Method development Method Validations Impurity Profiling RS Estimation Microbiology Stability Management Man
Slide 9: Generic/Branded Generic/OTC Product Development
Generic/Branded Generic/OTC Product Development Literature Survey Identification of API Supplier Patent Review Quality and Characterization of API Analytical Development – API Product Development Strategy Evaluation Procurement of API / RM / PM / RLD Lab Scale Development Analytica
Slide 10: Generic/Branded Generic/OTC Product Manufacturing
Generic/Branded Generic/OTC Product Manufacturing Technology Transfer Verification, Modifications & Adoption Scale up Batch Production /Modifications (Short Term Stability) Exhibit Batches Production Exhibit Batches Stability (Short Term & Long Term) Pivotal BE Supplies Compilation of Da
Slide 11: Product Development
Product Development
Slide 12: Solid Dosages
Solid Dosages Tablets: Immediate Release, Sustained Release, Delayed Release, Chewable, Orally Disintegrating (ODT) and Multilayered Capsules: Multi-particulates, Powders, Tablet in Capsule, Enteric Coating and Modified Release Powders: Immediate Release, Sustained Release, Delayed Release, Po
Slide 13: Oral Liquids
Oral Liquids Oral solutions, Syrups and Elixirs,… Oral suspensions Immediate Release and Powders for Suspensions Emulsions
Slide 14: Topicals
Topicals Topical Liquids: Rx, OTC and Personal Care Products for Topical Administration Topical (Semisolids): Rx, OTC and Personal Care Creams, Gels and Ointments for Topical or Oral Administration (dentifrice) Ear Drops Sterile Ophthalmic Preparations
Slide 15: Injectables
Injectables Terminal Sterilization Filtration Lyophilization Powder Filling
Slide 16: Process Development Capabilities – R&D
Process Development Capabilities – R&D High Shear Mixer Granulation (RMG) Fluid Bed Granulation (Top Spray) Roller Compaction & Slugging Tabletting (Conventional, Bilayer & Tablet in Tablet) Encapsulation (Powder, Pellet & Tablets or combination thereof) MUPS (Wurster & Extrusion-Spheron
Slide 17: Packaging Development
Packaging Development Blister Packing Strip Packing Bottle Packing Bulk Packing Liquids Packing Ointments
Slide 18: List of Equipments – R&D
List of Equipments – R&D S . No. Description Capacity S . No. Description Capacity 1 Vibro Mechanical Sifter 12 inch 13 Core Coated Tablet Press 20 STN 2 Double Cone Blender 2/5/20 lts Homogeniser (Silent 14 0.8 to 2000 ml Crusher) 3 Rapid Mixer Granulator 3/5/10 lts 500gm -1 kg & 3 kg 15 Autocoater
Slide 19: cGMP Pilot / Manufacturing
cGMP Pilot / Manufacturing
Slide 20: Manufacturing Support
Manufacturing Support Dosage Forms Solid Liquid Support • Scale up Batches • Exhibit Batches • Validation & Commercial Batches • Clinical Supplies • BE/BA Supplies
Slide 21: Solid Dosages
Solid Dosages Tablets: Immediate Release, Sustained Release, Delayed Release, Chewable and Orally Dissolving Capsules: Powders, Multi-particulates and Tablets in Capsules Powders: Immediate Release, Sustained Release, Delayed Release, Powders for Sachet or Suspension & Taste Masking Multi pa
Slide 22: Process Capabilities - Solids
Process Capabilities - Solids Blending Controlled Release Sizing/Milling Solubility Enhancement High Shear and Fluid Bed High and Low Dose Potency Granulation (aqueous or organic Taste-Masking solvents) Orally Disintegrating and Tabletting Chewable Tablets Encapsulation Packagi
Slide 23: Process Capabilities - Liquids
Process Capabilities - Liquids Topical liquids: Rx, OTC, and Personal care products for topical administration Oral solutions Oral suspensions: Immediate Release and Powders for Suspension
Slide 24: Manufacturing Equipment List
Manufacturing Equipment List S. No Description Capacity S. No Description Capacity Solid Dosage Form Module Semi Automatic self-adhesive 19 1 Multi Mill - labeling machine 2 Vibro Mechanical sifter 600 mm dia Auotmatic Capsule Filling 20 25000 Cap/Hr Machine 3 Rapid Mixer Granulator 75 & 150 L 21 Em
Slide 25: Liquid Oral Facility
LIQUID ORAL FACILITY Premixing Tank 1000L 2000L Mixing Tank and 2000L Holding Tank
Slide 26: Analytical Services
Analytical Services/
Slide 27: Analytical Method Development, Validation and Testing
Analytical Method Development, Validation and Testing Our fully equipped GLP Analytical Laboratory is well suited for Drug Product Analytical Method Development, Validation and Analysis to support R&D, Exhibit, Clinical, Validation and Commercial activities. Our Microbiology Lab is equipped to c
Slide 28: Pre-formulation Studies
Pre-formulation Studies Excipient Compatibility Studies Calorimetry by DSC Forced-Degradation Studies Solubility Determination Bulk Powder Characterization
Slide 29: Method Development and Validations, Dissolution, Cleaning Verification
Method Development and Validations • Assay • Related Substances • Chiral Purity Dissolution • USP Apparatus I • USP Apparatus II Cleaning Verification • Compound Specific Method • Total Organic Carbon (TOC)
Slide 30: Analytical Services: Microbiology Laboratory Instruments
ANALYTICAL SERVICES MICROBIOLOGY LABORATORY INSTRUMENTS • Horizontal Laminar Air Flow Benches (2 No's) • Incubators (2000 liters) • Cooling Incubator 2-8 °C (400 liters) • Autoclave • Colony Counter • Carl Zeisis Microscope
Slide 31: Analytical Services Infrastructure
ANALYTICAL SERVICES INFRASTRUCTURE • Walk-in Stability Chambers of 2,20,000 liters Capacity (10 numbers) • Centralized data acquisition for monitoring and trending Temperature and Humidity 24/7. • Stability Studies meeting the ICH Walk-in Stability Chambers Guidelines and any customer specific requi
Slide 32: ICH Stability Storage and Testing
ICH Stability Storage and Testing 40°C/75% RH 30°C/65% RH 30°C/75% RH Drug Product Delivery 25°C/60% RH 5°C Photo Stability Flexible Conditions
Slide 33: Analytical Instrumentation
Analytical Instrumentation Inductively coupled plasma mass spectroscopy (ICP-MS) HPLCs (DAD, UV & RI) UPLC (DAD & UV) RRLC (DAD) GC-HS LCMS Polari meter FTIR Particle Size Analyzer (Sympatec) Dissolution Tester - Auto Sampler UV-Vis Spectrophotometer Disintegration Tester BIO-DIS Dissolution Apparat
Slide 34: Collaboration - Partnership
Collaboration - Partnership WE BUILD Customer Focus Speed Transparency Quality Collaboration & Integrity Partnership Value Passion On Time Flexibility
Slide 35: Contact Details
Contact Details M. Mohan Rao V. Murali Krishna Prasad Vice President – Business General manager – CQO & Site Development Operations Ph: +91 9392483023 Ph: +91 9392483017 Email: [email protected] Email: [email protected] Regd. Office: Operations Office: Suven Life Sciences Ltd Suven Life Sciences Ltd
Slide 36: Thank You
Suven Life Sciences — Investor Presentation (July 2016) on 6ix