a culture called excellence                        Facilities-> Personnel-> Systems-> Solutions
Vision               To become a         leading player in offering          integrated solutions to           global phar...
Key Milestones                                                                                             2012           ...
Research & Development CenterHyderabad                   10-acre campus in ICICI Knowledge                   Park        ...
Drug Substance Manufacturing FacilityVisakhapatnam                    34 acre plot in Jawaharlal Nehru                   ...
Human Capital                A team of 850+ comprising 30 PhDs and                >525 Post Graduates (M.Sc, M.Pharm)    ...
Human CapitalOrganogram                         Chief Executive Officer    Executive Director    Executive Director       ...
Quality and Compliance                         Quality Management System                         guided by ISO9000:2000  ...
Business Units    Focused business units offering comprehensive solutions9
LAURUS Generics                  Cost effective processes and reliability                  of supply based on strong chem...
LAURUS Ingredients                     Manufacture of highly pure, well                     characterized specialty ingre...
LAURUS Synthesis                   Innovative, robust and scalable                   chemical development coupled with fl...
LAURUS SynthesisDrug Substance Services                   Focused Library synthesis (mg-gram scale)     Custom        Sy...
LAURUS SynthesisDrug Substance Services     Reaction & Process Capabilities Alkylation, Acylations                 Microwa...
LAURUS SynthesisDrug Substance Services     Comprehensive chemical development infrastructure     Scientifically designed ...
LAURUS SynthesisDrug Substance Services     Comprehensive chemical development infrastructure  Wiped Film Evaporator/Shor...
LAURUS SynthesisDrug Substance Services     Comprehensive drug substance manufacturing infrastructure Non-Potent & Interme...
LAURUS SynthesisAnalytical Development Services                      Initial drug substance characterization             ...
LAURUS SynthesisAnalytical Development Services     Comprehensive analytical development infrastructure     Comprehensive ...
LAURUS SynthesisProduct Development Services                      Pre-formulation Studies                      Prototype...
LAURUS SynthesisProduct Development Services     Comprehensive product development infrastructure     Complementary produc...
LAURUS SynthesisIP AssuranceComprehensive guidelines, SOPs in place, for handling of Client Information &Intellectual pro...
Affirmation              State-of-art infrastructure and              facilities manned by highly capable              pe...
Questions?                  Thank you!24
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Corporate Presentation Ll Focus Ls Mar 2012 V1

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Laurus labs is an innovation-driven¸ people-centric & client-focused organization offering a broad and integrated portfolio of products & services to the global pharmaceutical industry.

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Corporate Presentation Ll Focus Ls Mar 2012 V1

  1. 1. a culture called excellence Facilities-> Personnel-> Systems-> Solutions
  2. 2. Vision To become a leading player in offering integrated solutions to global pharmaceutical needs2
  3. 3. Key Milestones 2012 Equity Infusion of 2011 40mio USD by FGPI KFDA approval Rebranding of received at both company as Laurus sites Labs 2009 ; 2010 USFDA approval First commercial USFDA, TGA received at supply contract for Inspection Hyderabad a newly approved Nutraceutical drug signed with a First commercial 2007 ; 2008 Ingredients launched EU pharma product using Laurus First commercial API launched in the company Commenced Operations at product using Laurus USA API launched in R&D First phase of Europe center, Hyderabad capacity expansion 2010 - initiated at Vizag and Manufacturing USFDA, TGA, MHRA 2005 ; 2006 facility facility, Vizag Approvals received Incorporated as Accreditation of Equity infusion of a private limited Japanese PMDA 25mio USD by company received for Aptuit ,Inc. 2006 - Equity Hyderabad and infusion of 2008 – First DMF Vizag facilities 11mio USD by filed promoters3
  4. 4. Research & Development CenterHyderabad 10-acre campus in ICICI Knowledge Park 100% Export Oriented Unit (EOU) 400+ scientific staff in 160,000sq ft of R&D space with dedicated labs for chemical, analytical and formulation development 25,000 sq ft pilot plant including a containment block for handling potent APIs Small volume GMP manufacture of non- potent (~10kg batch) and high-potent APIs (~3kg batch) USFDA, TGA and KFDA approved4
  5. 5. Drug Substance Manufacturing FacilityVisakhapatnam 34 acre plot in Jawaharlal Nehru Pharma City 100% Export Oriented Unit (EOU) 380,000sq ft built-up space with 300,000L of reactor volume across 100+ vessels, capacities ranging from 50- 7500L Commercial-scale manufacture of non- potent (~500kg batch) and highly-potent APIs (~50kg batch) USFDA, MHRA, TGA, WHO-cGMP and KFDA approved 1000 Manufacturing Capacity (KL)… 0 2007-08 2010-11 2011-12 2012-13 2013-145
  6. 6. Human Capital A team of 850+ comprising 30 PhDs and >525 Post Graduates (M.Sc, M.Pharm) A top-class Scientific Management Team with experience ranging from 15 to 20 years in Global Pharmaceutical Industry and approx. 150 Patents and 175 research publications to their credit Highly equipped and dedicated workforce selected through rigorous screening process Strong emphasis on ongoing training and competency building Conducive work culture that encourages innovation at all levels6
  7. 7. Human CapitalOrganogram Chief Executive Officer Executive Director Executive Director Head Operations Finance Manufacturing Head Head In charge-Mfr R&D Finance Hyderabad Head Head In charge-Mfr Quality SCM Visakhapatnam Head Head BD HR Head Head PM IT7
  8. 8. Quality and Compliance Quality Management System guided by ISO9000:2000 Adherence to cGMP and GLP Conformance with all relevant ICH Guidelines8
  9. 9. Business Units Focused business units offering comprehensive solutions9
  10. 10. LAURUS Generics Cost effective processes and reliability of supply based on strong chemical development and manufacturing capabilities Leading manufacturer of anti-retroviral APIs and Oncology APIs Contract development and manufacture of API and intermediates 60 40 20 0 2007-08 2008-09 2009-10 2010-11 Products developed Patents Filed DMFs submitted10
  11. 11. LAURUS Ingredients Manufacture of highly pure, well characterized specialty ingredients for use in nutraceutical/ dietary supplements and cosmeceutical products Segment leading position in development (and manufacture of polyphenols, curcuminoids, hydroxycinnmic acids, flavonoids et al. Manufacturing and quality rigor matching that of the pharmaceutical APIs GRAS attested Kosher and Halal certified11
  12. 12. LAURUS Synthesis Innovative, robust and scalable chemical development coupled with flexi- scale drug substance manufacture Comprehensive, integrated analytical development at all phases Formulation development support for NCEs as well as for ANDA submissions Equipped to meet all NCE drug substance needs of the client, preclinical through to commercial manufacture Preclin, 3 PIII, 4 PI, 11 PII, 712
  13. 13. LAURUS SynthesisDrug Substance Services Focused Library synthesis (mg-gram scale) Custom Synthesis (gram-scale) of Building Blocks, Scaffolds, Reference Synthesis Compounds and Intermediate Compounds Capabilities across the scales in small molecule chemistry Potent/ Cytotoxic API development & synthesis Route scouting & Process development Chemical Process-transfer, Optimization & Scale-up Process Crystallization process, salt selection & polymorph control capabilities Development Process safety and hazard assessment Flexi-scale GMP Manufacture of Preclinical, clinical Phase I/II/III Drug APIs & Intermediates Substance High-Potent API Manufacture Cryogenic ((-50⁰C) to High temp (220⁰C) Manufacture Large-scale high pressure Hydrogenation CMC data generation at early (IND) to late-to-commercial-phase CMC & (NDA, DMF) DMF, CEP preparation, filing & maintenance Regulatory Support Tech-transfer, process validation, contract manufacture of non- potent & high-potent APIs & Advance Intermediates Knowledge of manufacturing site-change issues & support on all Contract regulatory aspects Late-clinical to comm. manufacture of API & adv intermediates of Manufacture newly approved drugs Contract development & manufacture of Off-Patent APIs (Generic & lifecycle APIs & advanced intermediates)13
  14. 14. LAURUS SynthesisDrug Substance Services Reaction & Process Capabilities Alkylation, Acylations Microwave synthesis (lab-scale only) Azide formation & Carbonylations Moisture sensitive reactions Catalytic reductions N-aminations, Nitrations Column Chromatography for multi-kilo Organometallic catalytic reactions (Air purifications and moisture sensitive) Glycosidations Ozonisation (lab-scale only) Peptide synthesis - Solid & solution Grignard Reaction phase Heck, Kumada couplings Sonogashira coupling, Suzuki coupling High pressure reactions (~25kg) Stereo selective & Chiral resolutions Hydrogenations Wittig reaction Low temperature reactions(-50deg C) Etc.14
  15. 15. LAURUS SynthesisDrug Substance Services Comprehensive chemical development infrastructure Scientifically designed & fully equipped chemical development labs with focus on safety & usability with 45 scientists in 6 labs  Comprehensive analytical infrastructure with 30 analysts dedicated for NCE CMC support & for standalone projects  Full containment labs for handling high-potents & cytotoxics  Chemist to fume-hood ratio of 1:1  Chemist to Analyst ratio of 1:1, as necessary  Access to databases/ scientific resources such as Scifinder®, Reaxys, Derwent World Patent Index, ACS® Journals  Membership of premier local institutional Libraries/ Databases (IICT & Hyderabad Central University)15
  16. 16. LAURUS SynthesisDrug Substance Services Comprehensive chemical development infrastructure  Wiped Film Evaporator/Short path distillation System  Preperatory HPLC  MPLC  Low pressure column chromatography  Microwave synthesis  Reaction calorimeter  Lyophilizers  Isolators for handling cytotoxic compounds  Ozonizer  Solid phase peptide synthesizer16
  17. 17. LAURUS SynthesisDrug Substance Services Comprehensive drug substance manufacturing infrastructure Non-Potent & Intermediate area (285,000L total volume)  Reactors SS (multiple, 50L - 7500L)  Reactors MSGL (multiple, 63L - 5000L)  Single Jacketed GLRs (multiple, 1L-20L)  Double jacketed GLRs (multiple, 20L) High-Potent Containment Area (14,000L total volume)  Reactors SS (multiple, 50L - 3000L)  Reactors MSGL (multiple, 63L - 2000L) Hydrogenation Area  25L(Hyderabad )  100L & 600L (Vizag) Column Chromatography Ultrafiltration Milling/ Micronization17
  18. 18. LAURUS SynthesisAnalytical Development Services Initial drug substance characterization Solid-state characterization services Clinical Phase Analytical methods development and transfer Analytical method validation Drug Forced Degradation studies Substance Stability Studies – accelerated & Full ICH Impurity identification, isolation, characterization Reference material and standards preparation Solid-state characterization (towards preformulation studies) Analytical methods development and transfer Analytical method validation Clinical –Phase Dissolution assay development & testing Drug Product Stability Studies – accelerated & Full ICH Analytical method development & validation Marketed APIs Stability Studies – accelerated & Full ICH Partial redevelopment & validation (triggered by regulatory Drug requirement gap analysis) Substance Pharmacopeial method verification Release Testing Analytical method development & validation Stability Studies – accelerated & Full ICH Deformulation studies Marketed Partial redevelopment & validation (triggered by regulatory Phase requirement gap analysis) Pharmacopeial method verification Drug Product Release testing18
  19. 19. LAURUS SynthesisAnalytical Development Services Comprehensive analytical development infrastructure Comprehensive analytical infrastructure with 30 analysts dedicated for NCE CMC support & for standalone projects  17 State-of-Art Analytical Laboratories  Walk-in Stability Chamber (9600L); Humidity Control Chamber (800L); Cooling Incubator (800L); Photo stability Chamber (243L)  General Analytical facilities such as HPLC; GC with all kinds of detectors & enhancements like head-space; KF-Auto-Titrators; Particle Size Analyzers; TOC Analyzer; UV-Vis etc.  Solid State Equipment such as NMR with Solid State capability; Powder XRD; FT-IR; DSC & TGA  Specialized Equipment like MPLC; Prep HPLC; AAS; CE; UPLC-DAF-MS/MS etc.19
  20. 20. LAURUS SynthesisProduct Development Services Pre-formulation Studies Prototype formulation Clinical Phase Dosage form development for early clinical phases Drug Product Solubility, stability data generation (for DP CMC sections of IND, NDA) Dosage form development for ANDA submissions (non- infringinging) Reformulation of lifecycle management products Generic/ Solubility, stability data generation (for all major regulatory agencies) Marketed Process optimization, qualification & validation Drug Product Pivotal batch production & Technology transfer20
  21. 21. LAURUS SynthesisProduct Development Services Comprehensive product development infrastructure Complementary product development infrastructure with 10 formulators  Rapid Mix Granulator (10 & 50L), Fluid bed Equipment (5 & 25L) , Octagonal Blender (10 & 50L)  Powder Mixture, Homogenizer, Double Cone Mixer, Dry & Wet Granulators, Single & Bi-layered Tab Compression Machine, Auto-Coater -30kg Capacity  Friabilator, Dissolution Apparatus (with Auto-Sampler) Disintegration Apparatus, Tap density Apparatus, Leak test Apparatus, I.R. Moisture Balance, Osmometer, Dissolved oxygen meter  Capsule Filling Machine, Blister Packing Machines (Alu-alu & PVC-alu), Strip Packing Machine, Induction Sealing Machine  Vial filling machine, Ampoule filling machine  Freeze Dryer System (18L)21
  22. 22. LAURUS SynthesisIP AssuranceComprehensive guidelines, SOPs in place, for handling of Client Information &Intellectual property generated during the course of the project executionAll employees, signatories to non-disclosure agreement on all proprietaryinformation – the definition of proprietary detailed within the CDA/ NDAQA commands oversight & control on the IP right through project initiation throughdelivery (assignment of project code, tech-transfer between sites & communication ofproject information to client)Project Information sharing within the members of the project team strictly on aneed to know basis & controlled by the assigned project lead through shared folderssystem & where client specifies, only through limited/ controlled copies of thedocumentsAll sensitive information will be duly redacted/ blacked-out’ on any projectdocumentation that needs to be shared with any external auditors/ regulatory bodiesIP generated on all client sponsored contract research & development projects isowned by the client & governed by T&Cs as specified in the MSA/ CDA/ NDA22
  23. 23. Affirmation State-of-art infrastructure and facilities manned by highly capable personnel Strong work ethic driven by sound systems and best practices, highest quality standards; emphasis on delivery and a strong focus on IP Sound business model built on being a strategic partner to the client and not merely a service provider Value creation through innovative science, customer centric approach and cost-effectiveness23
  24. 24. Questions? Thank you!24

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