Aarti Pharma Labs is a global pharmaceutical manufacturer with over 500 customers worldwide, specializing in APIs, intermediates, and xanthine derivatives. They have multiple manufacturing units in India and significant certifications ensuring compliance with global regulatory standards, while emphasizing their expertise in high-potency APIs and flexible manufacturing processes. The company aims for sustainable growth and continuous development of new products while ensuring quality and safety across their operations.

1. CORPORATE
PRESENTATION

2. Brief Profile
500+
Global Customers
3
USFDA Units
2000+
Employees
6
Manufacturing Units
150+
Products
2
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.
40 USDMF
20 CEP

3. Facilities
Vapi
Gujarat
Maharashtra
Manufacturing Sites
Unit - II Custom synthesis division (CSD)
Location: Vapi,
Unit – IV
Location: Tarapur
Unit - III & V
Location: Tarapur
Unit - I
Location: Dombivali
Head Office
Location: Mumbai
API, Intermediates &
CDMO Facility
Xanthine Derivatives
Manufacturing Facility
Head Office
R&D Centers
Location: Vapi, Dombivali
Product development
& Technology Transfer
SNo Facility / Unit
No of
Reactors
Total Capacity
(KL)
1 Unit - I, Dombivli 24 30
2 Unit - II, CSD, Vapi 129 550
3 Unit - III, Tarapur 57 470
4 Unit - IV, Tarapur 75 225
5 Unit - V, Tarapur 10 70
6 New Unit, Atali* 59 370
Total 354 1,715
Greenfield Project
Location: Atali
Upcoming Manufacturing
Facility
3
500 MT – 600 MT per annum production (API/NCE/RSM/INT)
Around 4,000 MT production for ‘Caffeine’
Unit-I and Unit-II has R&D 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

4. Our Journey so far
4
2001
Commissioning of first API
manufacturing Unit in
Dombivali (UNIT 1)
2011
2012
2013
2020
2019
Oncology block at Unit 4
receives EUGMP approval
for Bicalutamide
EUGMP approval for
3rd time for Unit 4.
• Unit 5 commissioned for Caffeine
Production with a capacity of 100 MT per
month
• Unit 4 clears USFDA audit for the 3rd time
• Cofepris, Mexico Audits cleared by
Unit 4
• Intermediate facility (CSD) at Vapi
clears USFDA for the 2nd time
Unit 4 clears USFDA audit
for the 4th time
KFDA Approval
2005
Commissioning of first API
manufacturing Unit in
Tarapur for Regulated
Markets (UNIT 4)
2008
1st Clearance of the
USFDA & EUGMP audit
by Tarapur Unit 4.
Unit 4 clears USFDA
audit for the 2nd time
Unit 4 Clears EUGMP audit 2nd
time in a row
2018
Oncology block at Unit 4
audited by EDQM for
Bicalutamide
2015 2016
2017
It’s been 22 years, and moving
towards further expansion and
sustained growth backed by
instituting enablers
2009
Intermediate facility (CSD) at
Vapi clears USFDA for the 1st
time
2023
New manufacturing site at Atali
for API/NCE & Intermediates

5. Management Team
5
Rashesh Gogri
Chairman
Masters – Production Engineer
Portfolios – Pharma (Head
Commercial)
Hetal Gogri Gala
Vice Chairperson & Managing DIrector
Electronics Engineer and MDP from
IIM – Ahmedabad
Portfolios – Pharma, HR & Admin
Narendra Salvi
Managing Director
Portfolios – Quality Systems, Pharma
Manufacturing
Parimal Desai
Non-Executive Director
Founder Director
Chemical Engineer from UDCT
Portfolios – Technical
Rajendra Gogri
Non-Executive Director
Masters – Chemical Engineer (IOWA
State USA)
Portfolios – Strategic Planning, New
Business, Development, Financial
Management

6. Strong Presence in API & Intermediates
6
50 APIs have been commercialized by APL since it
entered the pharma business in year 2000
10 new APIs are under development at APL’s
dedicated R&D facility for pharmaceuticals
20 CEP approvals available for sale in European
Union across multiple therapeutic areas
40 US DMF approvals obtained across multiple
therapeutic areas
100 ~100 Generic Intermediates are available at
R&D, Pilot and Commercial scales
Sterile Block
Isolators
Major therapeutic categories of Generic APIs for regulated markets
Cardiovascular Anti Cancer
Anti Asthamatic Anti Diabetic
Anti Coagulant CNS Agents

7. Xanthine Derivatives
7
• 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
• 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.
Certifications
• Caffeine Anhydrous
• Theophylline
• Aminophylline
• Etophylline
Xanthine Derivatives
End Use
Cola Drinks Energy Drinks Pharmaceuticals Nutraceuticals
Packaging
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

8. Portfolio Presentation
Modern PowerPoint Presentation
CDMO/CMC Services
• Synthetic Route Scouting & Design
• Process Development (DoE and QbD) & lab demonstration
• Custom Synthesis from kg to multi ton scales
• Process Engineering (Data Generation)
• Process Safety Studies / Process Hazard Analysis (RC1e & TSU studies)
• Salt Screening and polymorph studies
• Impurity Profiling (including impurities & reference standards synthesis)
• Genotoxic evaluation and validations
• Analytical method development and validations
• Process Validations
• Kilo & Pilot Scale Manufacturing (non-GMP & GMP) for IND phase and Tox batches
• Drug substances manufacturing for Clinical supplies (Ph-I/II/III)
• HPAPIs (OEL: 1 - 10 µg / m3 ; OEB: 4) development and manufacturing
• ICH Stability Studies
• CMC documentation support for regulatory filings and approvals
• Launch support and commercial manufacturing
7

9. Expertise in Chemistries
9
Strong
Expertise
Pd-Coupling Chemistry
Nucleoside, Nucleotide Chemistry
Chiral Chemistry
Carbohydrate Chemistry
Fluorine Chemistry
Triphosgene Chemistry
Nitration chemistry
Grignard Chemistry
Organoboron Chemistry
Lithiation Chemistry
Biocatalysis Hydrogenation

10. R&D Capabilities & Strengths
2
100
10
52
150
75
160
R&D scientists for Process research and
development of APIs, NCEs, RSMs, Intermediates
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
2 Research & Development facilities located
at Vapi & Dombivli
10
40 Analytical scientists for Method development,
Validations and Documentation

11. Manufacturing Capabilities & Strengths
Manufacturing
 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 (>15 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
11

12. Core technologies and Salient features
12
cGMP Manufacturing
Reactor Size:
• Kilo Lab: 50 to 100 Lit
• Pilot Scale: 100 Lit to 500 Lit
• Clinical/Commercial: 1KL to 10 KL
Production Capacity:
• Kilo Lab (1 - 5kg)
• Pilot Scale (10 - 50Kg)
• Clinical/Commercial (100kg - 100MT)
MOC:
• Glass lined
• Stainless steel
• Hastelloy
• Halar coated
Downstream Equipments:
• Centrifuges
• Nustche Filters
• ANFD, ATFE
• Sparkler Filters
• Fluid Bed Dryers
• Micronisers
• Falling Film Evaporators
Analytical Equipments
Chromatography:
• HPLC (UV, PDA, RI & ELSD)
• GC, GCHS (FID, TCD, ECD)
• UPLC, Ion Chromatography
Spectroscopy:
• UV-Vis, AAS, IR, NMR
• LCMS, GCMS
• ICPMS
Crystal, Thermal and Surface Analysis:
• pXRD
• DSC, TGA
• Particle size analyzer
• Development/POC (10 - 50g)
• Early clinical/Kilo/Pilot (1 - 10 kg)
• Commercial (100 - 150 kg)
HPAPI/Cytotoxics (OEB 4; up to 1µg/m3 OEL limit)
Flow Chemistry
• Lab to manufacturing scale (1kg – 1MT)
Niche areas:
• Cryogenic reactors size
(0.25 KL – 4 KL); 6 Reactors
• Hydrogenation reactors size
(0.25 KL – 10 KL); 12 Reactors
• Tray Dryers
• Vacuum Tray Dryers
• Rotocon Vacuum Dryer
• Multi Millers
• Jet Millers
• Blenders
• Sifters
11

13. Quality & Regulatory
QMS is in place
All SOPs and STPs are 21 CFR compliant
Regular on-job trainings and
cGMP trainings
Global regulatory accreditations
cGMP practices in line with various
global regulator bodies requirement
eBMR under implementation
13

14. 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
EUGMP Apr 2008, May 2012, Aug 2013, Jan 2015
EDQM Sep 2019
KFDA Nov 2017
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)
13

15. Data integrity & IP protection
Access control at all
locations and Labs
No mobile phones
access to labs and
manufacturing areas
Pen drives & external
drives disabled for
computers and laptops
Restricted access
to
email/websites
Use secured share
folder for large data
transfer to clients
Laptops and desktops
are encrypted
Mobile phone data
management system
is in place
Confidentiality
clauses in offer
letters
Customer data
confidentiality
maintenance
Systems to protect
organization data from
day-attacks/malware
HR training on IP
protection & Data
integrity
All generated IP
belongs to respective
clients
15

16. Quality Systems
16
Manufacturing
• 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
• 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
Engineering
• Equipment qualification
• Preventive & breakdown maintenance
• Calibration
• On-job training
Systems in
Quality
Control
Systems in
Quality
Control
Systems in
Warehouse and
Engineering
Systems in
Production

17. Safety, Health and Environment
Environment Management System
• 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)
Process Safety Management
• 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
• 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
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
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
Environment
Management
System
Process
Safety
Management
Aarti Pharma
Management
System
Safety & Health
Management
System
EMS PSM
APMS
SHMS
17

18. Supply Chain Sustainability
Supplier capacity
building program
Supplier engagement
Developing supplier
assessment questionnaire
Developing Green Procurement
Policy comprising comprehensive
ESG parameters
Developing supplier Code of
Conduct
Mapping of Critical suppliers
Site Audits
Mapping of Tier-2 and Tier-3
suppliers and establishing chain
of custody
18

19. 1
9
Commitment towards Society
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
19

20. 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
20

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