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Aarti Pharmalabs Corporate Presentation

Aarti Pharma labs Ltd specializes in the clinical phase and commercial production of APIs and NCEs, intermediates, regulatory starting materials, key building blocks and xanthine derivatives. Our offerings include process R&D, analytical method development and validations, stability studies, scale-up and process optimization, process validations and commercial production. The quality and purity of our products have enabled us to be the leading Active Pharmaceutical ingredients manufacturers in India.

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Aarti Pharmalabs Corporate Presentation

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  1. CORPORATE CORPORATE PRESENTATION PRESENTATION

  2. Brief Profile Xanthine Derivatives CDMO/CMC Services for NCEs Generic APIs and Intermediates • Largest Indian Manufacturer for Xanthine Derivatives (Caffeine and others) • 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 • 2 dedicated plants for our flagship product ‘Caffeine’ • Backward integrated intermediates for APIs • Dedicated blocks for Anti-Cancer and Cortico Steroids products • Key certifications – “Star Kosher”, “HACCP”, “Sedex SMETA-4PillarP”, “FSSC-22000 (GFSI)” for manufacturing & testing. • Exclusive Sterile block for Oncology products 150+ Products 500+ Global Customers 3 2000+ Employees 6 40 USDMF 20 CEP Manufacturing Units USFDA Units 2

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

  4. 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 3rdtime 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 2ndtime 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 2ndtime 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 3rdtime 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 It’s 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) 4

  5. Management Team Rashesh Gogri Chairman Parimal Desai Non-Executive Director Hetal Gogri Gala Vice Chairperson & Managing DIrector Narendra Salvi Managing Director Rajendra Gogri Non-Executive Director Electronics Engineer and MDP from IIM – Ahmedabad Masters – Production Engineer Founder Director Portfolios – Quality Systems, Pharma Manufacturing 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 5

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

  7. Xanthine Derivatives End Use • Xanthine derivatives are synthetic compounds that resemble natural occurring xanthines such as caffeine etc., • They bronchodilators, notably in the treatment of asthma or influenza symptoms are commonly used as mild stimulants & • Cola Drinks Energy Drinks Pharmaceuticals Nutraceuticals 2 Units of APL are dedicated to the manufacture of Xanthine Derivatives Certifications Xanthine Derivatives • Caffeine Anhydrous • Theophylline • Aminophylline • Etophylline Packaging • One of the largest manufacturer of Caffeine a capacity of 4000 MT annually Packaging Paper Box Fibre Drum Jumbo Bag • Xanthines are also commonly used in various beverages and energy drinks Quantity 20 kg 25 Kg 500 kg FCL Quantity in 20 Ft Container 10 MT 7 MT 10 MT • Customized particle size & dust free granules available. 7

  8. 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 Modern PowerPoint Presentation • Salt Screening and polymorph studies Portfolio Presentation CMC documentation support for regulatory filings and approvals • ICH Stability Studies • 7

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

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

  11. Manufacturing Capabilities & Strengths  Strong expertise in development of robust & cost-effective process for rapid scale up and commercial production  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  HPAPI (Cytotoxic/Oncology) and Cortico Steroids development and manufacturing  Flow Chemistry from lab scale to manufacturing scale  Experience in flawless delivery of clinical and commercial supplies  Hydrogenation facilities from lab scale to manufacturing scale (0.1 - 10 KL reactors)  Flexibility in adapting to client requirements for clinical supplies  Cryogenic reactors operating within temperature range of -800C to +1500C  Scaled more than 150+ processes from lab scale to commercial scale Manufacturing  High temperature and High vacuum distillations  Backward integration of raw materials to mitigate risks/delays  Detailed checklists and SOPs for seamless technology transfers  Highly versatile and flexible facilities across multiple locations  Dedicated project management and purchase teams to manage multiple projects, sites and clients communications  Capable to invest in new technologies and new/dedicated facilities  Engineering strength in building and improving manufacturing facilities in quick time  Quality and On Time In Full delivery 11

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

  13. 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 13

  14. Global Accreditations Site/Unit Name Regulatory Agency Month and Year of Audit Mar 2008, Sep 2011, Mar 2015, Dec 2016, Feb 2020 USFDA EUGMP Apr 2008, May 2012, Aug 2013, Jan 2015 Unit IV, Tarapur, Mumbai 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 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 15

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

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

  18. 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 Mapping of Tier-2 and Tier-3 suppliers and establishing chain of custody Supplier engagement 18

  19. 19 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 Aarti Pharmalabs Limited #204, Udyog Kshetra, 2ndFloor, Mulund Goregaon Link Road, Mulund West, Mumbai - 400080, Maharashtra, India. Email: info@aartipharmalabs.com Contact: +91 22 6797 6666 Aarti USA Inc., 31, Jurgelsky Road, Monroe Township, New Jersey - 08831, USA www.aartipharmalabs.com

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