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.

1. a culture called excellence
Facilities-> Personnel-> Systems-> Solutions

2. Vision
To become a
leading player in offering
integrated solutions to
global pharmaceutical
needs
2

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
promoters
3

4. Research & Development Center
Hyderabad
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 approved
4

5. Drug Substance Manufacturing Facility
Visakhapatnam
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 2013-14
5

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 levels
6

7. Human Capital
Organogram
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 IT
7

8. Quality and Compliance
Quality Management System
guided by ISO9000:2000
Adherence to cGMP and GLP
Conformance with all relevant
ICH Guidelines
8

9. Business Units
Focused business units offering comprehensive solutions
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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 DMF's submitted
10

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
certified
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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, 7
12

13. LAURUS Synthesis
Drug 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)
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14. LAURUS Synthesis
Drug 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.
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15. LAURUS Synthesis
Drug 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)
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16. LAURUS Synthesis
Drug 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 synthesizer
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17. LAURUS Synthesis
Drug 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/ Micronization
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18. LAURUS Synthesis
Analytical 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 testing
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19. LAURUS Synthesis
Analytical 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.
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20. LAURUS Synthesis
Product 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 transfer
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21. LAURUS Synthesis
Product 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)
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22. LAURUS Synthesis
IP 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 proprietary
information – the definition of proprietary detailed within the CDA/ NDA
QA commands oversight & control on the IP right through project initiation through
delivery (assignment of project code, tech-transfer between sites & communication of
project information to client)
Project Information sharing within the members of the project team strictly on a
need to know basis & controlled by the assigned project lead through shared folders
system & where client specifies, only through limited/ controlled copies of the
documents
All sensitive information will be duly redacted/ blacked-out’ on any project
documentation that needs to be shared with any external auditors/ regulatory bodies
IP generated on all client sponsored contract research & development projects is
owned by the client & governed by T&Cs as specified in the MSA/ CDA/ NDA
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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-effectiveness
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24. Questions?
Thank you!
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