CORPORATE PRESENTATION
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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
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HPAPIs development and manufacturing
Flow chemistry from lab to manufacturing
Complete CMC documentation support
APIs for regulated markets - USA, Europe, Korea and Japan
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Backward integrated intermediates for APIs
Dedicated blocks for Anti-Cancer and Cortico Steroids products
Exclusive Sterile block for Oncology products
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Largest Indian Manufacturer for Xanthine Derivatives (Caffeine and others)
2 dedicated plants for our flagship product ‘Caffeine’
Key certifications –
Kosher”,
Sedex SMETA-4PillarP”,
-22000 (GFSI)” for manufacturing & testing. 40 USDMF 20 CEP
“Star
“HACCP”, “
“FSSC
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
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
Oncology block at Unit 4 receives EUGMP approval for Bicalutamide
Unit 4 clears USFDA audit for the 2nd time
2015 2016 2017
2018
KFDA Approval
2023
2020 2019
New manufacturing site at Atali for API/NCE & Intermediates
Unit 4 clears USFDA audit
2012 2013
1st Clearance of the USFDA & EUGMP audit by Tarapur Unit 4.
Commissioning of first API manufacturing Unit in Dombivali (UNIT 1)
2008
2009
2011
• Cofepris, Mexico Audits cleared by Unit 4
Intermediate facility (CSD) at Vapi clears USFDA for the 2nd time
Oncology block at Unit 4 audited by EDQM for Bicalutamide
EUGMP approval for
Unit 4 Clears EUGMP audit 2nd
2001
2005
Commissioning of first API manufacturing Unit in Tarapur for Regulated Markets (UNIT 4)
Intermediate facility (CSD) at Vapi clears USFDA for the 1st time
It’s been 22 years, and moving towards further expansion and sustained growth backed by instituting enablers
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Management Team 5
Chairman Masters Production Engineer Portfolios – Pharma (Head Commercial)
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
Rashesh Gogri
Hetal Gogri
Non Executive Director Masters – Chemical Engineer (IOWA State USA) Portfolios Strategic Planning, New Business, Development, Financial Management
Rajendra
Gogri
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
Xanthine Derivatives
• 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
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Derivatives
2 Units of APL are dedicated to the manufacture of Xanthine
One of the largest manufacturer of Caffeine a capacity of 4000 MT annually
Xanthines are also commonly used in various beverages and energy drinks
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
Customized particle size & dust free granules available.
Portfolio Presentation Modern PowerPoint Presentation CDMO/CMC Services Synthetic Route Scouting & Design 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
Expertise in Chemistries
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Nucleoside, Nucleotide Chemistry Chiral Chemistry Carbohydrate Chemistry Fluorine Chemistry Triphosgene Chemistry Nitration chemistry Grignard Chemistry Organoboron Chemistry Lithiation Chemistry Biocatalysis Hydrogenation
Strong Expertise Pd-Coupling Chemistry
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
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
Manufacturing
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
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Core technologies and Salient features 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
& 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
Quality
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
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
• 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
Manufacturing
• 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
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
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Systems in Quality Control Systems in Quality Control Systems in Warehouse and Engineering Systems in Production
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)
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
Environment Management System
EMS PSM APMS SHMS
Process Safety Management
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
Aarti Pharma Management System
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
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Supply
Supplier capacity building program Supplier engagement Developing supplier assessment questionnaire
Green Procurement Policy comprising comprehensive ESG parameters Developing supplier Code of Conduct
of Critical suppliers Site Audits
of Tier-2 and Tier-3 suppliers and establishing chain of custody 18
Chain Sustainability
Developing
Mapping
Mapping
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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
Commitment towards
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
Aarti Pharmalabs Limited #204, Udyog Kshetra, 2nd Floor, Mulund Goregaon Link Road, Mulund West, Mumbai - 400080, Maharashtra, India.
THANK YOU
Contact: +91 22 6797 6666 Email: info@aartipharmalabs.com
Aarti USA Inc., 31, Jurgelsky Road, Monroe Township, New Jersey - 08831, USA www.aartipharmalabs.com
