Jubilant Pharmova Ltd

Jubilant Pharmova Limited, (Formerly known as Jubilant Life Sciences Limited), is an integrated global pharmaceutical and life sciences company engaged in Pharmaceuticals, Life Science Ingredients and Drug Discovery Solutions. The Company is engaged in pharmaceuticals, contract research and development services and proprietary novel drugs. The pharmaceuticals segment, through wholly owned subsidiary Jubilant Pharma Limited, is engaged in manufacture and supply of Active Pharmaceutical Ingredients (APIs), Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and NonSterile Products through 6 US FDA approved manufacturing facilities in India, USA and Canada with a network of over 48 radiopharmacies in the USA. The contract research and development segment provides drug discovery and development services as well as clinical data software and service solutions. . Proprietary novel drugs segment is a patientfocused biopharmaceutical business working to address unmet medical needs in oncology and autoimmune diseases. The Company was incorporated in 21st June, 1978. The Company tapped capital market in the year 1981 by the way of its Initial Public Offering (IPO). During the year 1983, the companys commercial production of Vinyl Acetate Monomer (VAM was started to enhance the value of the company. Research Development center of the company got recognition from Government of India in the year 1985. JLSL had introduced new products in Performance Chemicals segments during the period of 1987, Poly vinyl acetate emulsion for paint, textile, paper packaging and woodworking industry. In 1988, the company had launched its first branded product under the name of Vamicol, an adhesive product. The plant for Pyridine Picoline was started in the year 1990 and also the company received an ISO 9001 certification for its well known quality systems in the year 1995. During the year 1997, the first Multipurpose fine chemicals plant was gone to stream and also the plant for food polymer was commissioned. After a year, in 1998, JLSL had entered into high valueadded Pyridine derivates, commissioned Pyridine HBR and Cyano Pyridine plants. also in the same year, the company had formed marketing subsidiary in the USA and acquired acetyl plant in western India. The Company had penetrated the Bio / chemo informatics arena by setting up Jubilant Biosys Ltd in the year 2000. During the year 2001, the company had changed its corporate and business profile, due to this the new corporate identity was born as Jubilant Life Sciences Ltd. JLSL had acquired the Active Pharmaceutical Ingredients (API) business in the period of 2002. The new stateoftheart Research Development Centre of the company in Noida, near New Delhi was established in the year 2003 with all latest scientific instruments. The Company bagged Golden Peacock award for Innovation Management for the year 2003. During the year 2004, JLSL had set up medicinal chemistry services business through wholly owned subsidiary Jubilant Chemsys Ltd and also entered into formulations regulatory affairs businesses by acquiring Pharmaceuticals Services. In the same year the company had incorporated, N.V. and PSI Supply N.V., the pharmaceutical companies in Europe. JLSL had received C Acharya Award for Development of Indigenous Technology from ICMA for the year 2004. JLSL had acquired the Target Research Associates, Inc in the year of 2005 and renamed Clinsys Inc. a US based Clinical Research Organisation (CRO). Also in the same year, the company had acquired Trinity Laboratories, Inc. and its wholly owned subsidiary, Trigen Laboratories, Inc., renamed Jubilant Pharmaceuticals, Inc., a generic pharmaceutical company in USA having a US FDA approved formulations manufacturing facility. JLSL had embarked into Clinsys business by setting up wholly owned subsidiary under the name and style of Jubilant Clinsys Ltd. Jubilants stateoftheart Drug Discovery facility was inaugurated in Bangalore during November of the year 2006, the largest of its kind in India for providing integrated Drug Discovery solutions. As of June 2007, JLSL had completed the largest overseas acquisition in Contract Manufacturing by an Indian company, through its purchase of HollisterStier Laboratories (Hollister). A multimillion dollar long term agreement was signed with Syngenta in September of the year 2007 for the supply of Pyridines. In December of the year 2007, the company and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc had entered into a collaboration agreement through Jubilant Biosys Ltd., a subsidiary of Jubilant Organosys Ltd to discover small molecule drug candidates for a novel metabolic disorders target. JLSL had completed the transaction effective May of the year 2008, to acquire Canada based Draxis Speciality Pharmaceuticals Inc. (Draxis) for US 253 million and also in the same month of the same year, the company had acquired Speciality Molecules Pvt. Ltd., a niche manufacturer of Speciality Intermediates with manufacturing facilities located in Ambarnath (near Mumbai) in India for Rs. 199.5 million. The Company and Amgen Inc, Thousand Oaks, California, the largest US based Biotech Company, made a drug discovery partnership in July of the year 2008 through Jubilant Biosys Ltd subsidiary of Jubilant Organosys, under which Amgen and Jubilant collaborate to develop a portfolio of novel drugs in new target areas of interest across multiple therapeutic areas.During the year 200910, in line with continued strategy of enhancing its focus as a Pharmaceuticals and Life sciences company, the demerger of the Agri and Performance Polymer division into a separate company was approved in principle by the management on January 21, 2010. The demerged entity is Jubilant Industries Ltd where as the name of Jubilant Organosys is changed to Jubilant Life Sciences Ltd.During the year 201112, the company set up global plants of Vitamin B3 and 3Cyanopyridine, at Special Economic Zone making it the largest producer of Vitamin B3 in India and scond largest globally. It is also setting up a manufacturing plant at SEZ for Symtet, a crop science ingredient for one of the worlds largest and safest low cost insecticide through an environment friently process.During the year 201314, the company sold its Hospital business to Narayana Health. The business has been transferred on a going concern basis as a slump sale, which will enable it to focus on its core businesses in Pharmaceuticals and Life Sciences.In 201415, the company completed the consolidation of all its Pharmaceutical business under Jubilant Pharma, Singapore with effect from July 1, 2014.On 24 March 2014, Jubilant Chemsys, a whollyowned subsidiary of Jubilant Life Sciences, announced an extension of collaborative partnership with Infectious Disease Research Institute (IDRI) for TB drug discovery. The collaboration in chemistry support has been in existence since 2009 as part of a joint effort with the Lilly TB Drug Discovery Initiative (LTI) and so far has generated hundreds of Novel Chemical Entities (NCEs) some of which have now been identified for further exploration. Jubilant Chemsys, under the terms of agreement, so far had been offering philanthropic support and expertise in synthesis of NCEs to support the early research in TB. Jubilant Chemsys offers drug discovery research services on Full Time Equivalent and Fees forservices basis.On 13 May 2014, Jubilant Biosys, a Bengalurubased subsidiary of Jubilant Life Sciences, and Orion Corporation (Orion), the largest pharmaceutical company in Finland, announced a path breaking drug discovery collaboration to discover small molecule inhibitors in neuroscience therapeutic area. The research deal is aimed at developing drug that can benefit large population of people with unmet needs in the pain management area. As per the terms of agreement, Jubilants extensive experience in drug discovery and preclinical development will be utilised by Orion to address pain management needs of Central Nervous System (CNS). Jubilant will offer integrated drug discovery services across early discovery, synthetic and medicinal chemistry including scale up and preclinical services. The research for the project, which has been initiated, will be undertaken primarily at stateoftheart RD labs of Jubilant Biosys (India) and some parts at Jubilant Discovery Center, USA.On 26 May 2014, Jubilant Life Sciences announced that IFC, a member of the World Bank Group, is lending 147.5 million to Jubilant Pharma Limited, a wholly owned subsidiary of Jubilant Life Sciences Limited, to enable better access to quality and affordable pharmaceuticals in underserved markets in India and across the world. Of the total financing package, 110 million is from IFCs own account. The remaining 37.5 million is from IFCs Managed CoLending Portfolio Program, which provides additional longterm financing through cofinancing partners. The loan will help Jubilant Life Sciences increase focus on the pharmaceutical sector and strengthen its generic drug manufacturing facilities in India.On 30 September 2014, BioResource International, Inc. (BRI), a global biotechnology company specializing in the research, development and manufacture of highperformance, cost effective enzyme solutions for animal nutrition, signed a marketing agreement with Jubilant Life Sciences for marketing and distribution of selected feed enzyme products in South Asia. Jubilant will be the exclusive marketing partner of BRIs Xylamax and XylaQuick products in South Asia. Jubilant will market and distribute Xylamax and XylaQuick to large volume poultry producers, feed integrators, and animal health and nutrition consultants throughout India, Pakistan, Sri Lanka, Nepal, Bangladesh and Bhutan.On 23 December 2014, Jubilant Life Sciences Limited announced that its indirect whollyowned subsidiary, Jubilant Generics Inc. (Jubilant Generics), has successfully completed its previously announced Tender Offer for all of the outstanding shares of Cadista Holdings Inc. (Cadista Holdings) common stock not owned by Jubilant Generics or its affiliates. Jubilant Life Sciences has caused Jubilant Generics to complete a shortform merger with and into Cadista Holdings. No vote of Cadista Holdings stockholders was required in connection with the merger. As a result of the merger, all shares of Cadista Holdings held by the remaining minority stockholders of Cadista Holdings have been cancelled and, subject to appraisal rights under Delaware Law, converted into the right to receive a 1.60 per share in cash, without interest and less any required withholding taxes, the same consideration paid in the Tender Offer. Accordingly, Cadista Holdings has now become a whollyowned subsidiary of Jubilant Life Sciences Limited.On 12 June 2015, Jubilant Life Sciences announced that its subsidiary, Jubilant HollisterStier has been informed by the US Food and Drug Administration (USFDA) that its pharmaceutical sterile manufacturing facility in Spokane, Washington (USA) has been upgraded to the status of Voluntary Action Indicated (VAI). The Spokane sites latest Establishment Inspection Report (EIR) indicates the inspections in April 2014 and December 2014 have been successfully concluded. This upgradation by the USFDA from Official Action Indicated (OAI) to VAI is indicative of the cGMP status at the facility since receiving the warning letter in 2013.On 7 January 2016, Jubilant Biosys Ltd, a Bengaluru based subsidiary of Jubilant Life Sciences Ltd, and Sanofi Deutschland GmbH, Frankfurt, Germany, announced a strategic alliance to discover and develop small molecule inhibitors for multiple targets in the metabolic disorders therapeutic area. The research alliance is aimed at developing therapeutic small molecules that will address the unmet needs in diabetes and obesity. As per the terms of the agreement, Jubilant shall provide Sanofi integrated drug discovery and early development services across computational, synthetic chemistry, biology, GLP/ GMP services, to identify lead candidates and demonstrate clinical proof of mechanism in the metabolic disorders therapeutic areas. The research for the projects, which has been initiated, will be undertaken primarily at stateoftheart RD labs of Jubilant Biosys (Bengaluru, India) and Jubilant Chemsys (Noida, India).On 6 February 2016, Jubilant Life Sciences announced that Chinas Ministry of Commerce reduced AntiDumping Duty on its Pyridine to 17.6% from existing 24.6% based on the review petition filed by the company. The company will continue to evaluate the market conditions and get the benefit of reduced duty going forward.On 4 January 2017, Jubilant Life Sciences announced that its wholly own subsidiary Jubilant Pharma Limited, through one of its units Jubilant DraxImage Inc. Montreal Canada (JDI), has signed long term contracts with distribution networks in the US for supply of products used for diagnostic and therapeutic procedures for thyroid, myocardial perfusion, lung, kidney and bone scans to be supplied by JDI over a period of 39 months effective from January 2017.On 25 May 2017, Jubilant Life Sciences announced a price increase of up to 15% for its Vitamin B3 (Niacin Niacinamide) with immediate effect, for noncontract customers and wherever existing contracts permit. This is further to the price increase of up to 15% announced in December 2016On 21 June 2017, Jubilant Life Sciences announced a strategic partnership with Barentz International, an international leader in the distribution of highquality ingredients. The two companies have signed a commercial agreement to work together within the food nutrition market in India and its neighbouring countries. The collaboration aims at delivering solutions in food nutrition and fortification. Working with world class suppliers, Barentz offers a full portfolio of single specialty ingredients for food beverages, as well as custom nutritional and functional blends, produced at Barentz stateoftheart production facilities Vitablend in Singapore. Jubilant is the worlds second largest producer of Vitamin B3 (Niacinamide and Niacin), a vitamin that is extensively used in dietary food supplements, enrichment of breakfast cereals and flour, beverages and energy drinks, infant formulas, baking and confectionary. Together the two companies hope to make a significant impact in the area of micronutrient deficiency through solutions in food nutrition and fortification.On 1 September 2017, Jubilant Life Sciences Ltd announced that Jubilant Pharma Limited (JPL), a material wholly owned subsidiary of the company, through one of its wholly owned subsidiaries, has successfully completed the acquisition of the US radiopharmacy business of Triad Isotopes, Inc. The acquisition is a strategic fit to Jubilants niche nuclear medicine business and will provide the company with direct access to hospital networks with ability to deliver more than 3 Million patient doses annually through approximately 1,700 customers. The company intends to maintain and expand Triads distribution network. Triad operates the second largest radiopharmacy network in the US with more than 50 pharmacies. Triad recorded revenues in excess of US 225 Million in CY2016 with positive EBITDA and the acquisition is likely to be earnings accretive. This acquisition is funded through JPLs internal accruals with no increase in debt for Jubilant Life Sciences Limited.On 29 November 2017, Jubilant Biosys Ltd., a Bengalurubased subsidiary of Jubilant Life Sciences Ltd., announced that it has successfully achieved an early stage milestone related to a collaborative program with Sanofi in Frankfurt, Germany focused on metabolic disorders. The milestone reflects the successful transition of a collaborative program to the next phase in the discovery and development process. This alliance is part of a portfolio of programs, which began in 2016, focused on the discovery and development of small molecule inhibitors for multiple targets designed to address the unmet medical needs in diabetes and obesity. Jubilant Biosys confirmed receiving payment for the first milestone achievement for this collaboration. Jubilant Biosys will continue to apply its effective integrated drug discovery platform to generate novel molecules that can demonstrate clinical proofofmechanism.As on March 31, 2019, the Company had 50 subsidiaries.As on 31st March 2020, the Company had 44 commercial products and filed 97 Drug Master Files (DMFs) in the US, 44 CEPs in Europe, 40 DMFs in Canada, 15 Japanese DMFs and 14 filings in Australia. During the year 2020, Company increased the oral solid dosage capacity at their manufacturing facility in Roorkee, India by 1 billion doses to meet the growth requirements. It commercialised two new proprietary products during the year. It manufactured 3 new CDMO intermediates for US and Japan innovator companies which were 100% OnTime and InFull (OTIF) due to improved system procedures. Further, it launched health supplement products in the US market. During the year 2020, Company transferred, by way of slumpsale, its India Branded Pharmaceuticals Business on a going concern basis to Jubilant Generics Limited, a whollyowned subsidiary of the Company. As on March 31, 2020, the Company had 48 subsidiaries. The Company was also engaged in the Life Science Ingredients business till 1 February 2021. The Composite Scheme of Arrangement for amalgamation of certain promoter controlled entities into the Company and demerger of the Life Science Ingredients business into Jubilant Ingrevia Limited, the Resulting entity, was approved by Honble National Company Law Tribunal (NCLT), Allahabad Bench vide its Order dated 23 December 2020. The said NCLT Order was filed with the Registrar of Companies by the Company and the Resulting entity on 1 February 2021, thereby making the Composite Scheme effective. Effective 1st February, 2021 the Life Science Ingredients business demerged from Jubilant Pharmova Limited and name of the Company changed to Jubilant Pharmova Limited from Jubilant Life Sciences Limited effective from that date.In August 2021, the Company completed the chemistry research capacity expansion in Greater Noida and commissioned the new capacity.As on March 31, 2021, the Company had 39 subsidiaries. During the Financial Year 202021, Jubilant entered into a nonexclusive voluntary licensing agreement with Gilead to register, manufacture and sell Gileads investigational drug Remdesivir in 127 countries including India, as a potential therapy for COVID19 treatment. After getting approval from the Drug Controller General of India to manufacture and market the antiviral drug Remdesivir, JGL launched the lyophilized injection under its own brand name JUBIR and was able to manufacture inhouse Remdesivir API.As on March 31, 2022, the Company had 35 subsidiaries. As on March 31, 2022, there were 13 products marketed in the US with focus in the therapeutic areas of CVS, CNS, Anti Allergic, Steroids, etc. As of March 2022, Company filed 98 Drug Master Files (DMFs) in the US, 46 Certification of Suitability (CEPs) in Europe, 40 DMFs in Canada, 15 DMFs in Japan and 14 DMFs in Australia.In May 2022, the Company announced another expansion at the Spokane facility, to increase the injectable filling production capacity at the plant by 100% from current levels at a cost of US 192 million. During the year 2022, the Company voluntarily withdrew Losartan and Losartan HCTZ product from the US market following detection of a new category of azido impurities.During the year 2022, the Company commissioned the stateoftheart Chemistry Innovation Research Centre at Greater Noida, India to double the chemistry research capacity.During the year 202223, the Scheme of Arrangement between Jubilant Generics Limited (JGL) and the Company for Demerger of Active Pharmaceuticals Ingredients (API) undertaking/business of JGL and vesting of the same with the Company on a going concern basis with an Appointed Date of April 1, 2022 became effective on July 1, 2022. During the year 202223, the I131MIBG program for highrisk neuroblastoma made significant progress with recordhigh enrolment of patients in the OPTIMUM Phase II clinical trial. In 2023, the Company received the US FDA approval to use RUBY Rubidium Elution System and RUBYFILL (Rubidium Rb82 generator) in mobile settings. In May 2022, it expanded the facility at Spokane to increase the total injectable filling production capacity. During the year 2023, the Chemistry Innovation Research Centre at Greater Noida, India, was further expanded by 7000 sqft to provide in vitro ADME services to complement the chemistry service.