LUPIN LIMITED

Lupin is an innovation led Transnational Pharmaceutical Company producing, developing and marketing a wide range of branded & generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally. The Company has significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, Central Nervous System (CNS), Gastro-Intestinal (GI), Anti-Infective and Nonsteroidal Anti Inflammatory Drug (NSAID) therapy segments and is a global leader in the Anti-TB and Cephalosporins segments. Lupin Limited was incorporated in the year 1983 with the name Lupin Chemicals Limited. In March 2001, Lupin Laboratories Limited was amalgamated with the company and the name was changed to Lupin Limited. In the year 1987, the company commenced operations in Cephalexin Plant at Mandideep and 7 ADCA plant at Ankleshwar. In the year 1989, the company established a joint venture in Thailand, namely Lupin Chemicals (Thailand) Ltd. In the year 1991, they initiated production of Injectable cephalosporin (bulk and dosages) at Mandideep. In the year 1992, the company set up Fermentation Plant at Tarapur, Maharashtra. Also, Sterile Plant for injectable Cephalosporins (bulk) was commissioned at Mandideep. They commenced supply of Cephalosporin bulk actives to their alliance partners in the US. Also, they commissioned a state of the art US FDA approvable oral cephalosporin bulk active plant. In the year 2002, the company commissioned the new Anti-TB facility at Aurangabad. In the year 2003, they formed Lupin Pharmaceuticals Inc. USA, for trading, marketing and developmental activities in the US. In the year 2006, the company set up a new facility at Jammu. In the year 2007, the company acquired Vadodara based Rubamin Laboratories Ltd (rechristened to Novodigm Ltd). Also, they acquired Kyowa Pharmaceutical Industry Company Limited, a leading Generic Company in Japan. They started commercial production at their newly finished dosage facility at Jammu. Also, they set a new finished dosage facility at Indore. During the year 2008-09, the company expanded their product basket in Japan-Kyowa and received ten products approval from Ministry of Health & Labour Welfare, Japan. They acquired 100% stake in Hormosan Pharma GmbH, a generic company in Germany. Also, they acquired 36.65% stake in Generic Health Pty Ltd., in Australia, 60% stake in Pharma Dynamics in South Africa and 51% stake in Multicare Pharmaceuticals Philippines Inc in Philippines. During the year 2009-10, Lupin (Europe) Ltd, UK and Lupin Pharma Canada Ltd, Canada were incorporated on June 5, 2009 and June 18, 2009 respectively. Lupin Holding B V, the Netherlands transferred their holdings in Max Pharma Pty Ltd, Australia, a wholly owned subsidiary of the company to Generic Healthy Pty Ltd, Australia, an associated of the company upon which Max Pharma Pty Ltd ceased to be a subsidiary of the company with effect from May 31, 2009. In January 2010, as per the scheme of amalgamation, Novodigm Ltd, Lupin Pharmacare Ltd and Lupin Herbal Ltd, wholly owned subsidiaries of the company were amalgamated with the company with effect from April 1, 2009. In August 23, 2010, the company incorporated Lupin Mexico SA de CV, Mexico as a subsidiary company. The company increased their stake in Generic Health Pty Ltd., (Generic), Australia, from 49.91% to 76.65% and thus Generic became a subsidiary of the company with effect from September 27, 2010. Consequently, Bellwether Pharma Pty Ltd., Australia, Generic Health Inc., U.S.A. and Max Pharma Pty Ltd., Australia, which were subsidiaries of Generic, became subsidiaries of the company with effect from September 27, 2010. The company incorporated Lupin Philippines, Inc., Philippines and Lupin Healthcare Ltd., India, as subsidiaries on December 20, 2010 and March 17, 2011 respectively. In June 2011, the company's Generic Healthy Pty Ltd acquired worldwide rights for the Goanna Brand and the complete range of premium therapeutic oils, rubs and ointments marketed under the brand. In July 2011, the company entered into a research and development agreement with Medicis Pharmaceutical Corporation (Medicis) to apply Lupin technologies to multiple therapeutic compounds. In November 2011, the company acquired I'rom Pharmaceuticals through their Japanese subsidiary. In 2012, the company receives Tentative Approval for Generic Glumetza Extended-Release Tablets. The company announces settlement with SANTARUS and DEPOMED for GLUMETZA Patent Litigation. The company also launches Generic Geodon Capsules and Generic SEROQUEL Tablets during the year under review. In 2013, the company inaugurated new Plant at Nagpur. The company got Mahindra Samridhhi India Agri National Award for Bee keeping and Honey Production. In 2014, the company acquired Laboratorios Grin S.A. De C.V., Mexico; a Specialty Ophthalmic Company. The company enters the Latin American Market. The company also acquires Nanomi B.V. and enters Complex Injectables Space. The company receives FDA Approval for Generic Actos Tablets, and Generic Celebrex Capsules. In 2015, the company launches Generic DIOVANr Tablets. The company receives FDA Approval for Generic Vancocin Capsules. During the year under review, the company and Celon announce Strategic Development and Licensing Agreement for Generic Advair Diskus. The company and Rotary Join Hands to Combat Tuberculosis in Mumbai. The company introduces generic hypertension drug in US. The company also acquires Biocom in Russia during the year under review. On 24 July 2015, Lupin announced that it has entered into a strategic asset purchase agreement with TEMMLER PHARMA GMBH & CO. KG (Temmler), a part of the Aenova Group, one of the world's largest pharmaceutical contract manufacturers, to acquire Temmler's specialty product portfolio subject to certain closing conditions. On 7 August 2015, Lupin announced the opening of its new Center of Excellence for Inhalation Research in Coral Springs, Florida. On 14 October 2015, Lupin and Boehringer Ingelheim announced a joint strategic alliance for co-marketing linagliptin, a novel Dipeptidylpeptidase-4 (DPP-4) inhibitor in India. According to the agreement, Lupin will market and sell linagliptin under a separate brand name which will be promoted by Lupin's dedicated diabetes specialty field force. Boehringer Ingelheim will continue to sell its linagliptin under the brand names Trajenta (monotherapy) and TrajentaDuo (fixed-dose combination with metformin) through its existing sales force and network. On 9 March 2016, Lupin announced that it has completed the acquisition of privately held US based GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. (GAVIS). Lupin had announced the acquisition on 23 July 2015. The acquisition enhances Lupin's scale in the US generic market and also broadens Lupin's pipeline in dermatology, controlled substance products and other high-value and niche generics. New Jersey based GAVIS is a privately held company specializing in formulation development, manufacturing, packaging, sales, marketing, and distribution of pharmaceuticals products. On 15 March 2016, Lupin announced that the USFDA inspected its Goa manufacturing facility and cited 9 observations. The observations were on aspects such as inadequacy and adherence to standard operating procedures. Lupin said that it is in the midst of putting together a response to address USFDA's observations. On 26 May 2016, Lupin announced that it has received Establishment Inspection Reports (EIR) for its Mandideep and Aurangabad facilities wherein the USFDA has concluded that the inspections stand closed. The USFDA had conducted audits at Lupin's Mandideep facility from 8 to 19 February 2016 and its Aurangabad facility from 11 to 15 January 2016. On 2 August 2016, Lupin announced that its Japanese subsidiary Kyowa Pharmaceutical Industry Co., Ltd. has entered into a strategic asset purchase agreement with Shionogi & Co., Ltd., Japan to acquire 21 long-listed products from the Japanese company effective 1 December 2016, subject to certain closing conditions and regulatory approvals including the transfer of marketing authorization of the products to Kyowa. The 21 products cover therapy areas such as Central Nervous System (CNS), Oncology, Cardiovascular and Anti-infectives. On 6 October 2016, Lupin announced that its US subsidiary Lupin Pharmaceutical Inc. and MonoSol Rx, a specialty pharmaceutical company, have entered into a strategic licensing agreement wherein Lupin would develop multiple pediatric products utilizing MonoSol Rx's proprietary PharmFilm drug delivery technology. MonoSol Rx's PharmFilm technology is a drug delivery platform that provides precision dosing in the form of a quick-dissolving, taste-masked and easy-to-administer dissolvable film. On 13 October 2016, Lupin and Boehringer Ingelheim announced a strategic alliance to co-market Empagliflozin, a novel sodium glucose co-transporter-2 (SGLT-2) inhibitor in India. According to the agreement, Lupin will market and sell Empagliflozin under a separate brand name Gibtulio which will be promoted by Lupin's specialty field force. Boehringer Ingelheim will continue to sell Empagliflozin under the brand name Jardiance through its existing sales force and network. Headquartered in Ingelheim, Germany, Boehringer Ingelheim is one of the world's leading pharmaceutical companies. On 11 November 2016, Lupin announced the launch of a novel Iron Isomaltoside 1000 injectable iron formulation under two brand names ISOFER and JILAZO in India. Lupin acquired the exclusive rights to market, distribute and sell the novel injectable formulation from Denmark based Pharmacosmos A/S. Iron Isomaltoside 1000 is indicated for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used and when there is a clinical need to deliver iron rapidly. On 1 December 2016, Lupin and Eli Lilly and Company (India) Pvt. Ltd. (Lilly) announced an expansion of their partnership in India with the launch of Eglucent, a new brand of Lilly's rapid-acting insulin analog Lispro. Eglucent is indicated for the treatment of patients with diabetes mellitus. According to the agreement, Lupin will market and sell Eglucent through its own specialty field force while Lilly will be responsible for manufacturing and import. Lilly will continue to sell Lispro under the brand name Humalog through its existing channels. On 27 February 2017, Lupin announced that its Japanese subsidiary Kyowa Pharmaceutical Industry Co., Ltd. and Astellas Pharma Inc. have entered into an agreement providing Kyowa the exclusive right to distribute and promote extended-release tablets of quetiapine fumarate in Japan. Astellas submitted a new drug application (NDA) with the Ministry of Health, Labour and Welfare in Japan for extended-release tablets of quetiapine fumarate for the indication of improvement of depressive symptoms associated with bipolar disorder. On 16 May 2017, Lupin announced that it has acquired the rights to market, promote and distribute Eli Lilly and Company's Erectile Dysfunction (ED) product, Cialis in India through its specialty field force. On 21 July 2017, Lupin announced the successful completion of a PAI inspection (Prior Approval Inspection) carried out by the USFDA at its Goa manufacturing facility without any observations. On 18 July 2017, Lupin announced the successful completion of a GMP inspection as well as a PAI inspection (Prior Approval Inspection) carried out by the USFDA at its Pithampur, Madhya Pradesh manufacturing facility - Unit 1 without any observations. On 31 July 2017, Lupin announced the completion of a PAI inspection (Prior Approval Inspection) carried out by the USFDA at its Aurangabad, Maharashtra manufacturing facility with one 483 observation. The observation was procedural in nature and corrected during the inspection itself. On 11 October 2017, Lupin announced that its US subsidiary, Lupin, Inc., has acquired Symbiomix Therapeutics, LLC, a privately held company focused on bringing innovative therapies to market for gynecologic infections that can have serious health consequences. The acquisition has been made for a cash consideration of USD 150 million including a USD 50 million upfront and other time-based payments. In addition, there are sales based contingent payments. Lupin said that the acquisition was funded from internal funds. On 7 November 2017,Lupin announced that the company has received a warning letter from the USFDA for its formulation manufacturing facilities at Goa and Indore (Pithampur Unit II). Lupin said that there will be no disruption of existing product supplies from either of these two locations. However, there will likely be a delay of new product approvals from these two facilities, Lupin said. The company said that it plans to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues at the earliest. As on 31 March 2018, the Company had 33 subsidiaries and a joint venture. Pursuant to the application made to the Registrar of Companies (ROC'), Bangalore, by Novel Clinical Research (India) Pvt. Ltd., wholly-owned subsidiary of the Company, for removal of its name from the Register of Companies w.e.f. 27 March 2018, the ROC, vide its Order dated 08 December 2018, struck-off the name of the company from the Register of Companies. As part of restructuring, Lupin Ukraine LLC, Ukraine and Gavis Pharmaceuticals, LLC, USA, wholly-owned subsidiaries of the Company, were liquidated effective 07 February 2019 and 26 March 2019, respectively. As on 31 March 2019, the Company had 31 subsidiaries and a joint venture. During the FY2020,the company divested its entire stake in Kyowa Criticare Co Ltd,Japan and Kyowa Pharmaceutical Industry Co Ltd,Japan,effective 30 September 2019 and 09 December 2019 respectively. Consequently both entities ceased to be subsidiaries of the company. As part of internal restructuring on 02 October 2019,Nanomi,B.V.Netherlands,wholly owned subsidiary of the company,was merged with Lupin Holdings,B.V.Netherlands,wholly owned subsidiary of the company,effective 01 April 2019 and its name was changed to Nanomi,B.V.Netherlands. The name of Lupin IP Ventures Inc,USA was changed to Lupin Management Inc,USA effective from 10 March 2020. As on 31 March 2020, the Company had 26 subsidiaries and a joint venture. As part of restructuring, Lupin Middle East FZ-LLC, UAE and Lupin Japan & Asia Pacific K.K., Japan were liquidated, effective 02 July 2020 and 17 December 2020, respectively. Lupin GmbH, Switzerland was merged with Lupin Atlantis Holdings SA, Switzerland, effective 21 September 2020. As part of business expansion, Lupin Biologics Limited, India and Lupin Oncology Inc., USA were incorporated on 28 January 2021 and 15 March 2021, respectively, as wholly owned subsidiaries of the Company. As on 31 March 2021, the Company had 25 subsidiaries and a joint venture. As on March 31, 2022, the Company had 28 subsidiaries and a joint venture. On 03 February 2022, the Company acquired Southern Cross Pharma Pty. Limited, in Australia, as its wholly owned subsidiary. It acquired brand portfolios from Anglo-French Drugs & Industries Limited and its Associates in April 2022. In FY 2022, it closed an alliance with Foncoo Pharmaceutical Co. in China to commercialize CNS medications, to continue offering affordable and accessible healthcare to the world. In FY 2022, the Company had three US FDA site re-inspections and its Goa facility was upgraded allowing to introduce new product from this site. In FY 2023, the Company introduced first Metered Dose Inhaler Luforbec and launched the orphan drug 'Namuscla'. Also, it acquired Medisol in France to enhance its injectables franchise. In FY23, the Company expanded Specialty business portfolio by incorporating two inhalation products, Xopenex and Brovana, which were acquired from Sunovion in October 2022. In 2024, Lupin launched Lupin Digital Health (LDH), marking its foray into the burgeoning field of Digital Therapeutics (DTx). It launched Lyfe HF, catering specifically to patients dealing with heart failure. The Company had a strategic carve in API business, encompassing the manufacturing sites at Dabhasa and Vizag, as well as Fermentation and Enzymatic research at Lupin Research Park - Pune, to form its subsidiary, Lupin Manufacturing Solutions. A key launch was Tiotropium, the first approved generic version of Spiriva hand inhaler in the U.S. and Canada in 2024.