CHAPTER:-1

INTRODUCTION
INTRODUCTION ABOUT THE INDUSTRY:- 6

Lupin is an innovation led transnational pharmaceutical company developing and delivering a

wide range of branded & generic formulations biotechnology products and active
pharmaceutical ingredients (APIs) globally. The company is a significant player in the
Cardiovascular Diabetology Asthma Pediatric CNS GI Anti-Infective and NSAID space and
holds global leadership position in the Anti-TB segment.Lupin Ltd was incorporated in the
year 1983 with the name Lupin Chemicals Ltd. 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.In the year 2001 Lupin Laboratories Ltd was amalgamated with the company and
the name was changed to Lupin Ltd. 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