Aarti Pharmalabs Corporate Presentation

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CORPORATE PRESENTATION
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Brief Profile
CDMO/CMC Services for NCEs
Generic APIs and Intermediates
Xanthine Derivatives

• Development and manufacturing of RSMs,
• Intermediates and Drug substances for NCEs
• Early clinical phase till commercial supplies
• HPAPIs development and manufacturing
• Flow chemistry from lab to manufacturing
• Complete CMC documentation support

• APIs for regulated markets - USA, Europe,
• Korea and Japan
• Backward integrated intermediates for APIs
• Dedicated blocks for Anti-Cancer and Cortico
  Steroids products
• Exclusive Sterile block for Oncology products

• Largest Indian Manufacturer for Xanthine
• Derivatives (Caffeine and others)
• 2 dedicated plants for our flagship product
  Caffeine
• Key certifications Star Kosher, HACCP,
  Sedex SMETA-4PillarP, FSSC-22000 (GFSI) for
  manufacturing testing.

2000 Employees
6 Manufacturing Units
3 USFDA Units
150 Products
40 USDMF 20 CEP
500 Global Customers
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Facilities
Unit - II Custom synthesis division (CSD) Location Vapi, SNo Facility / Unit No of Reactors Total Capacity (KL)
RD Centers Location Vapi, Dombivali Maharashtra RD Centers Location Vapi, Dombivali Maharashtra SNo Facility / Unit No of Reactors Total Capacity (KL)
RD Centers Location Vapi, Dombivali Maharashtra RD Centers Location Vapi, Dombivali Maharashtra 1 Unit - I, Dombivli 24 30
RD Centers Location Vapi, Dombivali Maharashtra RD Centers Location Vapi, Dombivali Maharashtra 2 Unit - II, CSD, Vapi 129 550
RD Centers Location Vapi, Dombivali Maharashtra RD Centers Location Vapi, Dombivali Maharashtra 3 Unit - III, Tarapur 57 470
RD Centers Location Vapi, Dombivali Maharashtra RD Centers Location Vapi, Dombivali Maharashtra 4 Unit - IV, Tarapur 75 225
RD Centers Location Vapi, Dombivali Maharashtra RD Centers Location Vapi, Dombivali Maharashtra 5 Unit - V, Tarapur 10 70
RD Centers Location Vapi, Dombivali Maharashtra RD Centers Location Vapi, Dombivali Maharashtra 6 New Unit, Atali 59 370
RD Centers Location Vapi, Dombivali Maharashtra RD Centers Location Vapi, Dombivali Maharashtra Total 354 1,715
Gujarat
Greenfield Project Location Atali
Vapi
Unit IV Location Tarapur
Unit - III V Location Tarapur
500 MT 600 MT per annum production
(API/NCE/RSM/INT) Around 4,000 MT production for
Caffeine Unit-I and Unit-II has RD Centers and
pilot plants Unit-IV has dedicated Anti Cancer,
Steroids, Sterile Blocks Unit-III V are
dedicated units for Xanthines manufacturing Atali
manufacturing unit will be operational by 2023
Unit - I Location Dombivali
Head Office Location Mumbai
Manufacturing Sites
API, Intermediates CDMO Facility
Xanthine Derivatives Manufacturing Facility
Product development Technology Transfer
Upcoming Manufacturing Facility
Head Office
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Our Journey so far

• Unit 5 commissioned for Caffeine Production with
  a capacity of 100 MT per month
• Unit 4 clears USFDA audit for the 3rd time

KFDA Approval
2023
Oncology block at Unit 4 receives EUGMP approval
for Bicalutamide
2020
2019
2018
New manufacturing site at Atali for API/NCE
Intermediates
2017
Unit 4 clears USFDA audit for the 2nd time
2016
2015
Unit 4 clears USFDA audit for the 4th time

• Cofepris, Mexico Audits cleared by Unit 4
• Intermediate facility (CSD) at Vapi clears USFDA
  for the 2nd time

2013
Oncology block at Unit 4 audited by EDQM for
Bicalutamide
2012
2011
1st Clearance of the USFDA EUGMP audit by
Tarapur Unit 4.
EUGMP approval for 3rd time for Unit 4.
2009
Commissioning of first API manufacturing Unit in
Dombivali (UNIT 1)
Unit 4 Clears EUGMP audit 2nd time in a row
2008
Its been 22 years, and moving towards further
expansion and sustained growth backed by
instituting enablers
Intermediate facility (CSD) at Vapi clears USFDA
for the 1st time
2005
2001
Commissioning of first API manufacturing Unit in
Tarapur for Regulated Markets (UNIT 4)
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Management Team
Rashesh Gogri Chairman Masters Production
Engineer
Hetal Gogri Gala Vice Chairperson Managing
DIrector
Narendra Salvi Managing Director Portfolios
Quality Systems, Pharma Manufacturing
Parimal Desai Non-Executive Director
Rajendra Gogri Non-Executive Director
Electronics Engineer and MDP from IIM Ahmedabad
Founder Director
Masters Chemical Engineer (IOWA State USA)
Portfolios Pharma (Head Commercial)
Chemical Engineer from UDCT
Portfolios Pharma, HR Admin
Portfolios Strategic Planning, New Business,
Development, Financial Management
Portfolios Technical
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Strong Presence in API Intermediates
APIs have been commercialized by APL since it
entered the pharma business in year 2000
new APIs are under development at APLs
dedicated RD facility for pharmaceuticals
40 20 100
US DMF approvals obtained across multiple
therapeutic areas
Isolators
CEP approvals available for sale in
European Union across multiple therapeutic areas
100 Generic Intermediates are available at RD,
Pilot and Commercial scales
Major therapeutic categories of Generic APIs for
regulated markets
Cardiovascular Anti Asthamatic Anti Coagulant
Anti Cancer Anti Diabetic CNS Agents
Sterile Block
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Xanthine Derivatives
End Use

• Xanthine derivatives are

synthetic
compounds
that
resemble natural occurring xanthines such as
caffeine etc.,

• They are commonly used as mild stimulants
  bronchodilators, notably in the treatment of
  asthma or influenza symptoms
• 2 Units of APL are dedicated to the manufacture
  of Xanthine Derivatives

Cola Drinks
Energy Drinks
Pharmaceuticals
Nutraceuticals
Certifications
Xanthine Derivatives

• Caffeine Anhydrous
• Theophylline
• Aminophylline
• Etophylline

Packaging

• One of the largest manufacturer of Caffeine a
  capacity of 4000 MT annually
• Xanthines are also commonly used in various
  beverages and energy drinks
• Customized particle size dust free granules
  available.

Packaging Paper Box Fibre Drum Jumbo Bag
Quantity 20 kg 25 Kg 500 kg
FCL Quantity in 20 Ft Container 10 MT 7 MT 10 MT
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CDMO/CMC Services

• Synthetic Route Scouting Design
• Process Development (DoE and QbD) lab
  demonstration
• Process Engineering (Data Generation)
• Process Safety Studies / Process Hazard Analysis
  (RC1e TSU studies)
• Custom Synthesis from kg to multi ton scales
• Kilo Pilot Scale Manufacturing (non-GMP GMP)
  for IND phase and Tox batches
• Drug substances manufacturing for Clinical
  supplies (Ph-I/II/III)
• Process Validations
• Launch support and commercial manufacturing
• HPAPIs (OEL 1 - 10 µg / m3 OEB 4)
  development and manufacturing
• Analytical method development and validations
• Impurity Profiling (including impurities
  reference standards synthesis)
• Genotoxic evaluation and validations
• Salt Screening and polymorph studies
• ICH Stability Studies
• CMC documentation support for regulatory
  filings and approvals

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Expertise in Chemistries
Pd-Coupling Chemistry
Chiral Chemistry
Nucleoside, Nucleotide Chemistry
Carbohydrate Chemistry
Strong Expertise
Fluorine Chemistry
Lithiation Chemistry
Triphosgene Chemistry
Grignard Chemistry
Nitration chemistry
Organoboron Chemistry
Biocatalysis
Hydrogenation
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RD Capabilities Strengths
2 2 Research Development facilities located at
Vapi Dombivli 100 40 10 52 150 75 160
RD scientists for Process research and
development of APIs, NCEs, RSMs, Intermediates
Analytical scientists for Method
development, Validations and Documentation
Average years of experience of most of Chemists
/ Scientists
52 Process patents filed
Process for more than 150 products developed and
manufactured on kilo lab scale
More than 75 products commercialized
Target to develop 120 new products in next 2
years and another 160 new products by 2025
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Manufacturing Capabilities Strengths

• Strong expertise in development of robust
  cost-effective process for rapid scale up and
  commercial production
• HPAPI (Cytotoxic/Oncology) and Cortico Steroids
  development and manufacturing
• Flow Chemistry from lab scale to manufacturing
  scale
• Hydrogenation facilities from lab scale to
  manufacturing scale (0.1 - 10 KL reactors)
• Cryogenic reactors operating within
• temperature range of -800C to 1500C
• High temperature and High vacuum distillations
• Detailed checklists and SOPs for seamless
  technology transfers
• Dedicated project management and purchase teams
  to manage multiple projects, sites and clients
  communications
• Quality and On Time In Full delivery

• 20 years of experience in pharmaceuticals
• manufacturing to several global clients
• Impeccable regulatory track record (gt15 years)
  and facilities approved by several pharma
  clients from EHS and Quality perspectives
• Experience in flawless delivery of clinical and
  commercial supplies
• Flexibility in adapting to client requirements
  for clinical supplies
• Scaled more than 150 processes from lab scale
  to commercial scale
• Backward integration of raw materials to
• mitigate risks/delays
• Highly versatile and flexible facilities across
  multiple locations
• Capable to invest in new technologies and
  new/dedicated facilities
• Engineering strength in building and improving
  manufacturing facilities in quick time
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Manufacturing
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Core technologies and Salient features
cGMP Manufacturing Reactor Size
Analytical Equipments Chromatography

• Kilo Lab 50 to 100 Lit
• Pilot Scale 100 Lit to 500 Lit
• Clinical/Commercial 1KL to 10 KL

• HPLC (UV, PDA, RI ELSD)
• GC, GCHS (FID, TCD, ECD)
• UPLC, Ion Chromatography

Production Capacity
Spectroscopy

• Kilo Lab (1 - 5kg)
• Pilot Scale (10 - 50Kg)
• Clinical/Commercial (100kg - 100MT)

• UV-Vis, AAS, IR, NMR
• LCMS, GCMS
• ICPMS

MOC

• Glass lined
• Stainless steel
• Hastelloy
• Halar coated

Niche areas
Crystal, Thermal and Surface Analysis

• Cryogenic reactors size (0.25 KL 4 KL) 6
  Reactors
• Hydrogenation reactors size
• (0.25 KL 10 KL) 12 Reactors

• pXRD
• DSC, TGA
• Particle size analyzer

Downstream Equipments
HPAPI/Cytotoxics (OEB 4 up to 1µg/m3 OEL limit)

• Centrifuges
• Nustche Filters
• ANFD, ATFE
• Sparkler Filters
• Fluid Bed Dryers
• Micronisers
• Falling Film Evaporators

• Tray Dryers
• Vacuum Tray Dryers
• Rotocon Vacuum Dryer
• Multi Millers
• Jet Millers
• Blenders
• Sifters

• Development/POC (10 - 50g)
• Early clinical/Kilo/Pilot (1 - 10 kg)
• Commercial (100 - 150 kg)

• Flow Chemistry
• Lab to manufacturing scale (1kg 1MT)

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Quality Regulatory
eBMR under implementation QMS is in place All
SOPs and STPs are 21 CFR compliant cGMP
practices in line with various global regulator
bodies requirement Regular on-job trainings
and cGMP trainings Global regulatory
accreditations
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Global Accreditations
Site/Unit Name Regulatory Agency Month and Year of Audit
Unit IV, Tarapur, Mumbai USFDA Mar 2008, Sep 2011, Mar 2015, Dec 2016, Feb 2020
Unit IV, Tarapur, Mumbai EUGMP Apr 2008, May 2012, Aug 2013, Jan 2015
Unit IV, Tarapur, Mumbai EDQM Sep 2019
Unit IV, Tarapur, Mumbai KFDA Nov 2017
Unit IV, Tarapur, Mumbai COFEPRIS Apr 2017, May 2017
Unit II, CSD, Vapi, Gujarat USFDA Sep 2009, Aug 2017
Unit I, Dombivli, Mumbai USFDA Jun 2022 (Waiting for EIR report)
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Data integrity IP protection
Access control at all locations and Labs
No mobile phones access to labs and
manufacturing areas
Laptops and desktops are encrypted
Mobile phone data management system is in place
Pen drives external drives disabled for
computers and laptops
Restricted access to email/websites
Use secured share folder for large data
transfer to clients
Customer data confidentiality maintenance
Systems to protect organization data from
day-attacks/malware
HR training on IP protection Data integrity
Confidentiality clauses in offer letters
All generated IP belongs to respective clients
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Quality Systems

• Approval and distribution Procedures
• Sampling of intermediates and finished products
• QA release
• Annual product reviews
• Co-Ordination and Approval of validations
  qualifications
• Approval of change control assessment of
  related risks
• Approval of deviation and assessment of related
  risks
• Corrective and preventive action
• Handling of client complaints, recall, product
  return
• Internal quality audits
• Vendor qualification
• Investigation in to OOS results assessment of
  related risks
• On-job training

• Approved specifications test methods
• Analytical method verification
• Stability studies
• Retained samples
• Management of primary / reference / working
• standards
• Calibrations
• Qualifications of testing equipment
• Investigation in to OOS assessment of related
  risks
• Microbial evaluations
• Release for raw material and packing material
• On-job training

Systems in Quality Control
Systems in Quality Control

• Pre-inspection checks and allotting unique
  identification numbers, sampling requests
• Dispensing of raw / packing materials.
• Assignment of quarantined / approved / rejected
  status and storage of materials
• Distribution controls
• Handling of rejected / returned goods
• Handling of waste materials
• On-job training

Warehouse

• Pre-inspection checks and allotting unique
  identification numbers, sampling requests
• Dispensing of raw / packing materials.
• Assignment of quarantined / approved / rejected
  status and storage of materials
• Distribution controls
• Handling of rejected / returned goods
• Handling of waste materials

Systems in Warehouse and Engineering
Systems in Production
Engineering

• Equipment qualification
• Preventive breakdown maintenance
• Calibration
• On-job training

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Safety, Health and Environment
Environment Management System
Process Safety Management

• ISO 14001 2015 certification
• Zero Liquid Discharge (ZLD) plants - 5 No.
• Approx. 50 water of total water consumption is
  recycled
• Green chemistry principles incorporated during
  product development stage
• Recycle reuse of solvents and safe disposal of
• Hazardous waste
• Regulatory compliance monitoring through
  Compliance Mgt. System (CMS)

• In-house Process Safety Laboratory - RC1 and TSU
  studies for all processes
• Designed inherently safe processes
• Powder safety studies conducted applied in
  commercial scale.
• Hazop studies at various stages Implementation
  of
• recommendations at sites

PSM Process Safety Management
EMS Environment Management System

• Management of Change (MOC) through Change control

• Pre Start-up Safety Review (PSSR) at various
  stages
• EHS aspects checklist for New Technology
  Transfers product development

APMS Aarti Pharma Management System
SHMS Safety Health Management System

• Aarti Pharma Management System
• APMS at par with CCPS OHSAS
• Guidelines released by corporate then site SOPs
  initiated
• Training Development of EHS coordinators
• Behaviour Based safety
• Near Miss reporting
• Reward Recognition
• EHS cultural transformation

Safety Health Management System

• Hazard Identification and Risk Assessment (HIRA),
  Hazardous Area Classification (HAC) and work
  permit system in place
• Safety Trainings - Induction, On the job,
  Classroom, Demos
• Incident management - Safety Alert, Learning
  from Incidents, Root cause analysis and Global
  CAPA Implementation
• Safety Thought For The Day- One slide tool
  circulated
• Industrial Hygiene study conducted
• COVID 19 Protocol followed at all sites

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Supply Chain Sustainability
Developing Green Procurement Policy comprising
comprehensive ESG parameters
Developing supplier Code of Conduct
Developing supplier assessment questionnaire
Mapping of Critical suppliers
Supplier capacity building program
Site Audits
Supplier engagement
Mapping of Tier-2 and Tier-3 suppliers and
establishing chain of custody
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Commitment towards Society
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Cluster Rural Development
Education Skill Development
Childcare Healthcare Facilities
Women Empowerment Livelihood Opportunities
Disaster Relief Rehabilitation
Water Conservation Environment
Research Development for Upliftment of
Society
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Value Proposition with APL

• Sustainable supply for APIs/NCEs/Intermediates in
  commercial scale
• Global regulatory accreditations (USFDA ,EUGMP,
  EDQM, KFDA, COFEPRIS)
• EHS and Quality are the highest priority.
  Facilities were audited as per PSCI principles
• High potent molecules (Oncology/Cytotoxic)
  development and manufacturing
• Backward integration strength for raw materials
• Strong know-how in end-to-end CMC documentation
  for regulatory filings

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THANK YOU
Aarti Pharmalabs Limited 204, Udyog Kshetra, 2nd
Floor, Mulund Goregaon Link Road, Mulund West,
Mumbai - 400080, Maharashtra, India. Email
info_at_aartipharmalabs.com Contact 91 22 6797
6666 Aarti USA Inc., 31, Jurgelsky Road, Monroe
Township, New Jersey - 08831, USA
www.aartipharmalabs.com