Pharmaceuticals - Jubilantpharmova

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Pharmaceuticals

CONTENTS020708Company OverviewRadiopharma (combiningradiopharmaceuticals andradiopharmacies)Contract Manufacturingof Sterile Injectables andNon-sterile products091011Allergy Therapy ProductsGenericsActive PharmaceuticalIngredients (APIs)121314-16ManufacturingResearch & Developmentand Intellectual PropertyBusiness Excellence,Supply Chain,Sustainability

Leading marketpositions acrossbusiness lines, withhigh barriers toentry for specialtypharmaceuticalsCompany OverviewJubilant Pharma Limited is a global integrated pharmaceuticalcompany offering a wide range of products and services toour customers across geographies. We organise our businessinto three segments, namely, Specialty Pharmaceuticals,comprising Radiopharma (combining radiopharmaceuticals andradiopharmacies) and Allergy Therapy Products; CDMO, comprisingContract Manufacturing of Sterile Injectables & Non-sterile productsand Active Pharmaceutical Ingredients; and Generics.We supply our products and services to customers in over 85countries. We have four manufacturing facilities in North Americaand two in India, coupled with Research and Development centers inNorth America and India. In addition, we have a distribution networkof more than 50 radiopharmacies in the United States.Revenue FY 2019 USD 761 millionDistribution network of more than 50 radiopharmacies in the2United States

Business SegmentsPharmaceuticalsGlobal FootprintOperations in following countries Radiopharma (combiningradiopharmaceuticals andradiopharmacies)USA Allergy Therapy ProductsIndiaCDMOSingapore Contract Manufacturing of SterileInjectables and Non-sterile products(CMO)Belgium Active Pharmaceutical Ingredients (APIs)CanadaChinaSouth AfricaGenerics3

Leadership PositionsRadiopharmaAllergy Therapy Products Third largest radiopharmaceuticalmanufacturer in the nuclear medicineindustry in the United States based onrevenue One of the top three players in theallergenic extract market in theUnited States and are currently thesole producer and supplier of venomproducts for the treatment of allergies inthe United States Second largest centralised commercialradiopharmacy network in the United Stateswith a national footprint of more than50 radiopharmacies across 22 statesActive PharmaceuticalIngredientsGenerics One of the market leaders in the UnitedStates, based on market share of several keyproducts One of the global suppliers for several key‘API’ products based on market share6 US FDA Inspected/Accredited Manufacturing Facilities(4 in North America and 2 in India)4

Manufacturing FacilitiesKirkland, Montreal, CanadaSalisbury, Maryland, USAHealth Canada and the US FDA inspected/accreditedfacility for RadiopharmaceuticalsHealth Canada, US FDA and DEA inspected/accreditedfacility for GenericsKirkland, Montreal, CanadaNanjangud, Karnataka, IndiaUS FDA, Health Canada inspected/accredited facilityfor Sterile Injectables and Non-sterile productsUS FDA, PMDA Japan, KFDA Korean and COFEPRISMexico inspected/accredited facility for ActivePharmaceutical IngredientsSpokane, Washington, USAUS FDA, MHRA, Health Canada, PMDA Japaninspected/accredited facility for Sterile InjectablesUS FDA and Health Canada inspected/accreditedfacility for Allergy Therapy ProductsRoorkee, Uttarakhand, IndiaUS FDA, EU, PMDA Japan, Health Canada, ANVISABrazil and SAPHRA South Africa inspected/accreditedfacility for Generics Research and Development centers in North America and India Team of over 450 R&D professionals5

We offer products and services across thepharmaceuticals value chain. We have threebusiness segments,PharmaceuticalsBusiness Overview(i) Specialty Pharmaceuticals,comprising Radiopharma (combiningradiopharmaceuticals and radiopharmacies)and Allergy Therapy Products;(ii) CDMO, comprising Contract Manufacturingof Sterile Injectables & Non-sterile productsand Active Pharmaceutical Ingredients; and(iii) Generics, comprising Formulations and APIs.6

RadiopharmaJubilant Radiopharma is an industry-leading pharmaceutical company specializing in nuclear medicine. Thecompany is focused on developing, manufacturing, commercializing and distributing high quality, sustainablediagnostic and therapeutic agents for the sole purpose of IMPROVING LIVES THROUGH NUCLEAR MEDICINE on aglobal scale.Radiopharmaceuticals Division has a solid foundation for the diagnosis and treatment of various diseases.Radiopharmacies Division is focused on compounding and distributing patient specific unit doses ofradiopharmaceuticals and services to local Nuclear Medicine departments.Nuclear Medicinemarket leader inNorth Americafor lung and bonescintigraphy andI-131 thyroiddisease therapyStrong portfolio ofdifferentiated productsincluding RUBY-FILL Rb-82 Generators andI-131 Sodium Iodine,MAA and DTPANew product pipeline includesI-131 MIBG (Iobenguane)an ultra-orphan drug usedfor paediatric treatment ofneuroblastoma and other keyimaging agents in nuclearmedicineClinical applications includediagnostic imaging forCardiology, Oncology,Pulmonary, Kidney, Brainand Skeletal, as well asRadiotherapy for Thyroid andother CancersRegulatory approvalsin US, Canada,Central & SouthAmerica, Europe andSouth AsiaStrong new productdevelopment pipelinewith a series of key genericproducts used widely ingeneral nuclear medicinediagnostics and therapyWorldwide ExportsNorth America, LatinAmerica, Europeanand Asian MarketsServing nearly 4 millionpatients each year, makingJubilant Radiopharmaciesthe second-largest nuclearpharmacy network in theUnited StatesNetwork of specializedradiopharmacies provide singlephoton emission computedtomography (SPECT) and positronemission tomographic (PET)prescriptions to local hospitals andoutpatient imaging centers across thenational US marketManufacturing FacilityOver 50 RadiopharmaciesKirkland, Montreal, CanadaAcross 22 states in USHealth Canada and the US FDA inspected/accreditedfacility for RadiopharmaceuticalsEmploying over 700 highly skilled professionals7

ContractManufacturingof Sterile Injectablesand Non-sterileproductsJubilant HollisterStier is an integratedcontract manufacturer of sterile injectables,ophthalmics, otics and sterile and non-sterileproducts - ointments, creams and liquids. Leading contract manufacturer of Clinical toCommercial Sterile injectables Broad range of capabilities including sterileinjectables (vials and ampoules), ophthalmicsand otics (tubes and bottles) and non-sterileproducts - ointments, creams, and liquids(bottles, tubes, and pumps) Serving global leaders in pharmaceutical &biopharmaceutical industries Offering turn- key services including full testing,regulatory support, supply chain support,secondary packaging, cold chain management,stability, CMC support and serializationManufacturing FacilityKirkland, Montreal, CanadaSpokane, Washington, USAUS FDA, Health Canada inspected/accredited facilityfor Sterile Injectables and Non-sterile productsUS FDA, MHRA, Health Canada, PMDA Japaninspected/accredited facility for Sterile Injectables8

AllergyTherapyProductsManufacturing FacilitySpokane, Washington, USAUS FDA and Health Canada inspected/accredited facilityfor Allergy Therapy products*Ranking as per Frost & SullivanWe provide Allergy Therapy Products to the allergyspecialty industry with a product offering range ofover 200 different allergenic extracts and standardallergy vaccine mixtures as well as six different insectvenom products for the treatment of allergies toinsect stings.We are one of the top three players* in the allergenicextract market in the United States and are currentlythe sole producer and supplier of venom products forthe treatment of allergies in the United States.We produce and market a number of products underthe HollisterStier brand. Our Allergy Therapy Productsbusiness line has traditionally focused on NorthAmerica as our key market, where we believe wehave generated significant brand loyalty due to thequality of our products and long-standing operatinghistory. We also market some of our key productssuch as allergenic extracts and venom extracts inCanada, Europe, Australia and New Zealand throughdistributors. Our Allergy Therapy Products aremanufactured at our Spokane Facility. The primarytarget user base of our Allergy Therapy Products areallergists, ear, nose and throat physicians, generalphysicians and hospital-based clinics across NorthAmerica.9

GenericsWe are engaged in the development,manufacture, sale and distribution ofprescription generic pharmaceuticalproducts principally in the United States,and with a growing presence in Europe,Canada, Japan, Australia, as well as theRest of the World. We focus primarily onthe manufacture and sale of generics forCVS, CNS, GI and Anti-allergy therapeuticcategories. The business derives benefitfrom vertically integrated into our APIsbusiness.Experienced in developing over 100 moleculesacross therapeutic categories of CVS, CNS,Antiinfective, Pain, Respiratory, Antidiabetic andUrology Capable of developing multiple products forvarious geographies including USA, EU, Canada,Japan, China, Australia, Brazil and RoW Markets In-house BA/BE unit audited by US FDA and otherkey regulatory agencies In the United States market, till September 30,2019, we have made a total of 96 ANDA filings forgenerics of which 35 are pending approval In non-US markets, till September 30, 2019, wehave made a total of 900 filings for generics, ofwhich 661 are approved As at September 30, 2019, we had 55commercialised generic products across theUnited States, Europe, Canada, Australia and theRest of the World. Our in-house APIs capability provides us stablesource of APIs supply for availability of theseproducts at competitive pricesMultiple dosage forms / containment capabilities Immediate release oral solids Modified release oral solids Steroids Potential for liquids, ointments, powders,ophthalmics and injectables Experience in developing formulations forveterinary business A leading formulations player - Development,manufacture and sale of proprietary Formulations Creating differentiated dosage forms with MUPSbased products, ODT, chewable tablets, PowderFor Oral Solutions & Suspensions etc.Manufacturing FacilitySalisbury, Maryland, USARoorkee, Uttarakhand, IndiaHealth Canada, US FDA and DEA inspected/accredited facility for GenericsUS FDA, EU, PMDA Japan, ANVISA Brazil and MCC South Africainspected/accredited facility for Generics10

ActivePharmaceuticalIngredients (APIs)Jubilant is a preferred partner of choice across the globe for innovator and generic pharmaceutical companies.Jubilant APIs business has prominent presence in markets such as North America, South America, Europe, Japan,APAC (Asia Pacific) and Middle East.Jubilant offers one of the broadest portfoliocomprising of more than 90 different APIs fromvarious therapeutic categories like CNS, CVS,Anti-infective, Anti-diabetic etc. Proven expertise to operate large scale chemicaloperations, which is key to better cost efficiencies Global leaders in Carbamazepine,Oxcarbazepine, Pinaverium, Risperidone,Valsartan etc. Diversified & large external customer base to drivegrowth across multiple regions Business sustainability & supply assurance frombackward integration of key APIs Best in Class quality compliance, with excellenttrack record on successful multiple inspections byvarious regulatory bodies such as US FDA, HealthManufacturing FacilityNanjangud, Karnataka, IndiaCanada, ANSM-France, ANVISA- Brazil, TGAAustralia, PMDA- Japan, COFEPRIS-Mexico andKFDA APIs manufacturing site spans over an area of2,67,000 square mts. with 33% built-up area;6 large scale manufacturing blocks and a pilotplant; 170 reactors having volumetric capacity of760 KL and 18 clean rooms World class APIs R&D team comprises of morethan 150 synthesis & analytical scientistsincluding PhDs; Expertise in complex chemistriessuch as Chiral separation, Low Temp reactions,Bio-transformation, Stereo-selective synthesis,continuous flow reactions; equipped with latestanalytical instruments such as LC HRMS, NMR, XRD,LCMS, etc. Analytical expertise in polymorphiccharacterization and contamination, Genotoxic &Carry over studies, Impurity profiling etc. Dedicated DoE/QbD cell for bringing qualityand process robustness during the productdevelopment.US FDA, PMDA Japan, KFDA Korean and COFEPRIS inspected/accredited facility for Active Pharmaceutical Ingredients11

ManufacturingGlobal competitive edge dueto integrated and efficientmanufacturing operationsWe believe our large scale capacity manufacturingsites in India provide us with cost advantages in termsof wages and raw materials prices as compared tomany of our global competitors, as well as economiesof scale. In addition, by virtue of our integratedoperations, we believe that we enjoy competitiveadvantages in the form of cost efficiencies byproducing across the value chain, thereby reducingour dependence on third parties for supply of startingmaterials and helps to insulate us from significantvolatility in raw materials prices.The APIs from our manufacturing facility are usedfor our generics business. Such integration betweenour Generics and APIs business lines allows us tocontinuously improve our cost of production. Multipleproducts in our Radiopharmaceuticals and AllergyTherapy Products business lines are manufactured inour CMO facilities.Additionally, our radiopharmaceutical products aredistributed through more than 50 radiopharmacies.We operate our plants in accordance with cGMP and/or other applicable requirements. We currently operatefour US FDA inspected/accredited manufacturingfacilities in North America and two US FDA inspected/accredited manufacturing facilities in India.12Manufacturing FacilitiesNorth AmericaKirkland, Montreal, CanadaHealth Canada and the US FDA inspected/accreditedfacility for RadiopharmaceuticalsKirkland, Montreal, CanadaUS FDA, Health Canada inspected/accredited facility forSterile Injectables and Non-sterile productsSpokane, Washington, USAUS FDA, MHRA, Health Canada, PMDA Japan inspected/accredited facility for Sterile InjectablesUS FDA and Health Canada inspected/accredited facility forAllergy Therapy ProductsSalisbury, Maryland, USAHealth Canada, US FDA and DEA inspected/accreditedfacility for GenericsINDIANanjangud, Karnataka, IndiaUS FDA, PMDA Japan, KFDA Korean and COFEPRIS Mexicoinspected/accredited facility for Active PharmaceuticalIngredientsRoorkee, Uttarakhand, IndiaUS FDA, EU, PMDA Japan, Health Canada, ANVISA Braziland SAPHRA South Africa inspected/accredited facility forGenerics

Research &Developmentand IntellectualPropertyStrong product pipeline with deep R&DcapabilitiesIn radiopharmaceuticals (till September 30,2019), we are focused on high value nicheproducts with diagnostic and/or therapeuticuses like successful 505(b)2 NDA inspection/accredition by US FDA DraxImage Exametazimeand RUBY-FILL . Another 505(b)2 NDA filingprocess for I-131 MIBG is ongoing along with 4other products under development. We have ourown in-house radiopharmaceutical distributioncapabilities, thereby reducing our reliance onthird party radiopharmaceutical distributors.We also have a strong pipeline in our Generics and APIsbusiness segment and since we commenced operations(through to September 30, 2019): for generics we havefiled 96 ANDAs in the United States, of which 35 ANDAsare pending approval; For APIs, we have filed 96 DMFsin the United States. In addition, as on September 30,2019, we have 15 sterile filings, of which two ANDAs arepending approval in the United States.We have R&D centers located in North Americaand India and we employ a team of over 450 R&Dprofessionals with expertise in the development ofnovel, robust and non-infringing processes for APIsand generics, as well as specialized and/or nicheformulations and designs for radiopharmaceuticalsand other products, which have been taken tocommercialisation. Our R&D continues to lead to new,innovative processes and new knowledge-drivenproducts that increase the efficiencies of our productionand allow us to capitalise on opportunities for growthin competitive markets. As on September 30, 2019, wehave been granted patents for intellectual property invarious countries for innovation, including 12 activepatents granted relating to APIs in a number of differentcountries, 4 active access patents granted relating togenerics in a number of different countries, 81 activepatents granted relating to radiopharmaceuticalproducts in a number of different countries and 01active patent granted relating to allergy therapyproducts in the United States.13

BusinessExcellenceIn Jubilant Pharma, Business Excellencefunction is proactively creating theframework for new improvementstrategies which drives the competitiveadvantage backed by a strong executionmechanism & capability. Theseimprovement strategies pertain to allthree critical pillars of the organisation –CUSTOMER, PROCESS & PEOPLE.During the journey of continual improvement, wehave adopted various improvement methodologiesin line with organisation priorities Lean Six Sigma,Total Productivity Maintenance (TPM), BusinessIntelligence Framework backed with BusinessIntelligence (BI) Tools etc.14Highlights: Lean Six Sigma tools are used for capacitydebottlenecking and process simulation toolsbacked by statistics is used for APIs, Generics,Supply Chain process optimisation. QbD (Quality by Design) is an approach followedin new product development for generatinga robust design space which in turn helpsdeveloping Right First Time products. Lean Lab as a concept is followed for optimizingefficiencies in Quality Lab area where by speedof execution without any error is key driver forimprovement. Cash to Cash cycle time reduction and workingcapital improvements are driven across allbusinesses by following best in class Lean andSupply Chain practices. EBITDA maximization approach is followed forimprovement project selection.

Supply ChainCustomer delivery through effectiveand efficient logistics and supplychain managementThe goal of Supply Chain Management (SCM) atJubilant is to provide a substantial and sustainablevalue contribution to its customers for the success ofour businesses.Jubilant strives to play an integral role in allgeographies where we operate. The guidingprinciples for our supply chain have been set underour Green Supply Chain Policy. To fulfil our GreenSupply Chain commitments, the evaluation criteriacover clauses on compliance to EHS, human rightsand social requirements relevant laws of the land. Supplier Audits are conducted annually to covercritical vendors at least once in three years.It include performance assessment againstparameters such as environment, labour practice,human rights and social impact. Local Sourcing: The Company sources its material,machinery, spares stores etc. from across theglobe without compromising on quality andvalue. Preference is given to local suppliers if theysatisfy the requisite specifications. Training Programs: Road safety duringtransportation of its products and raw materialsis of prime concern to the Company. In order toimprove transporter safety, ‘Behavioural SafetyTraining with focus on defensive driving’ isimparted to transport service providers. All domestic tanker movement are trackedthrough GPS for safety & timely delivery, goingforward all export shipments will also be trackedonline to ensure timely delivery to customers.Highlights: Jubilant emphasises and invests in Life CycleManagement (LCM) of all its products consistentlyto be a reliable and a sustainable suppliermeeting global quality standards. Partners in progress meet to collectively innovate& optimise a sustainable value chain. Paperless Sourcing: Jubilant uses ane-procurement tool that enables paperlessbuying. It ensures greater efficiency andtransparency in procurement process andinformation flow by use of tools like reverseauction.15

SustainabilityJubilant’s Promise of Caring, Sharing,Growing finds life in each of themany sustainability endeavoursof the Company. We take pride inour long and momentous journeyby creating long term value for ourstakeholders.Jubilant follows Triple Bottom Line approach towards sustainability and is reporting sustainability performanceof the Company following Global Reporting Initiative (GRI) Guidelines since 2003.Jubilant is signatory to United Nations Global Compact principles. Jubilant is also GRI Gold Community Memberand a Member of GRI South Asian Consortium in Chemicals Sector.The Company through stakeholder engagement identified focus areas and set Sustainability Targets 2020 onenvironment, safety and community services.Climate Change Jubilant is aware about business implications andresponsibilities arising out of Climate Changeacross the globe. In response the Company hasadopted Climate Change Mitigation Policy whichaims to reduce its climate change impact throughreduced carbon footprint. Jubilant participates in Carbon Disclosure Projectto publicly demonstrate its Greenhouse Gasemission performance and commitments. The Company uses renewable energy sources likesolar, bio-diesel etc. in its energy mix to reducecompany’s carbon footprint. There is dedicated team to identify, plan,budget, implement, monitor and report resourceefficiency improvement projects.Environment, Health and Safety (EHS) The Company’s approach towards best-in-classEHS standards is articulated in the EHS Policy. Dedicated EHS teams at manufacturing facilities& corporate office effectively manage the EHSperformance of the Company. Safety culture in terms of safe behaviour is being16aggressively promoted and propogated atworkplace EHS & sustainability performance of the Companyis reviewed by sustainability and CSR committeeat Board level regularly.Customer Health and Safety Strong team involving R&D, QA, QC, sales andmarketing to take care of product safety Good Manufacturing Practices (GMP), US FDA,Health Canada, PMDA (Japan), KFDA (Korea),COFEPRIS (Mexico) and other inspections/accreditions are there for exporting products torelevant countries.Corporate Social Responsibility (CSR) Jubilant’ s CSR initiatives thrust on creating valuein the lives of the communities around the area ofoperations of the Company Jubilant CSR initiatives are focused in the realmof Education, Health, Livelihood and SocialEntrepreneurship The Company is aligning its sustainability effortsalong with UN SDGs (Sustainable DevelopmentGoals) and refer these SDGs while planning/adopting any new / existing communitydevelopment projects.

Jubilant Pharma Limited is a globalintegrated pharmaceutical companyoffering a wide range of productsand services to our customersacross geographies. We organiseour business into three segments,namely, Specialty Pharmaceuticals,comprising Radiopharma(combining Radiopharmaceuticalsand Radiopharmacies) andAllergy Therapy Products; CDMO,comprising Contract Manufacturingof Sterile Injectables & Non-sterileproducts and Active PharmaceuticalIngredients; and Generics.Registered OfficeJubilant Pharma Limited80 Robinson Road, #02-00,Singapore-068898,T: 65 6236 3333Office Locations:SingaporeIndiaCorporate OfficeJubilant Generics LimitedPlot No. 15, Knowledge Park- II,Greater Noida – 201306, Uttar Pradesh, IndiaTel: 91 0120 7186000Jubilant Pharma Limited6 Temasek Boulevard, Suntec Tower Four,#20-06 Singapore 038986T: 65 6235 4129USACanadaJubilant HollisterStier LLC3525, N. Regal, Spokane,Washington 99207, USATel: 1 509 489 5656Jubilant HollisterStier Inc.Contract Manufacturing & Services Division 16751Trans-Canada Highway,Kirkland, Québec, Montreal,Canada H9H 4J4Tel : 1 514 630 8220Jubilant Cadista Pharmaceuticals Inc.207, Kiley Drive, Salisbury,Maryland 21801, USATel : 1 410 860 8500Jubilant Pharma Holdings Inc.790 Township Line Road, Suite 175Yardley, PA 19067, USATel: 1 215 550 2810Jubilant DraxImage (USA) Inc.2711 Centerville Road, Suite 400,City of Wilmington, 19808,County of New Castle, Delaware, USAwww.jubilantpharma.com support@jubl.comJubilant Draxlmage, Inc.16751, Trans-Canada Highway,Kirkland, Québec, Montreal,Canada H9H 4J4Tel : 1 514 630 7030BelgiumJubilant Pharmaceuticals N.V.Axxes Business Park, Guldensporenpark 22,Blok C B - 9820 Merelbeke, BelgiumTel : 32 9 233 1404

Carry over studies, Impurity profiling etc. Dedicated DoE/QbD cell for bringing quality and process robustness during the product development. Jubilant is a preferred partner of choice across the globe for innovator and generic pharmaceutical companies.