ALKEM LABORATORIES LTD.

Headquartered in Mumbai, India, Alkem Laboratories Limited is a leading Indian pharmaceutical company with global operations. The company is engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals, which it markets in India and international markets. With a portfolio of more than 800 brands in India, Alkem is ranked the fifth largest pharmaceutical company in India in terms of domestic sales. The company also has presence in more than 40 international markets, with the United States being its key focus market. Alkem Laboratories Limited was incorporated as a private limited company on August 8, 1973 in Patna and subsequently became a deemed public limited company on October 26, 1988. Pursuant to Company passing a resolution under section 21 of Companies Act, 1956 and upon issuance of a fresh certificate of incorporation consequent on change of name dated August 21, 2001, the name of the Company was changed to 'Alkem Laboratories Limited' with effect from October 26, 1988. In 1978, the company established its first plant at Taloja Maharashtra. In 1992, the company established its manufacturing facility in Mandwa, Maharashtra, which was later converted into an API facility in 2005. In 2003, the company set up a research and development facility for ANDA development at Taloja, Maharashtra. During the year 2006, the company's anti-infective drug Taxim became the first anti-infective drug in the Indian pharmaceutical industry to cross Rs 100 crore in terms of domestic sales in India. In 2007, the company filed its first ANDA in the US for the drug Amlodipine. In 2009, the company received first ANDA approval in US for Amlodipine. Also during the year, the company acquired Pharmacor Pty Ltd., a generic pharma company in Australia. In 2010, Alkem Laboratories acquired Ascend Laboratories, a generic marketing company in the US. In 2011, the company acquired Enzene, a company engaged in the development of biosimilars in India. In 2012, the company acquired an API manufacturing facility in the US. In 2014, the company acquired the 'Clindac-A' brand in India from Galderma S.A. Also during the year, Clavam crossed Rs 200 crore mark in terms of domestic sales in India. In 2015, the company acquired a formulation manufacturing facility in the US. During the FY2015,the company has done the stock split reduced the face value of equity share from Rs 10 to Rs 2 and also approved and allotted 59782500 bonus shares in the ratio of 1:1. On 23 December 2015, Alkem Laboratories successfully completed an Initial Public Offering (IPO) with its equity shares listed on the Bombay Stock Exchange Limited and the National Stock Exchange of India Limited. On 10 May 2016, Alkem Laboratories announced that the Competition Appellate Tribunal (COMPAT) has passed an order dated 10 May2016 setting aside the penalty of Rs 74.63 crore imposed on the company by the Competition Commission of India (CCI) in its order dated 1 December 2015. On 7 June 2016, Alkem Laboratories announced the closure of the inspection by the United Kingdom - The Medicines and Healthcare Products Regulatory Agency (UK-MHRA) for its Bioequivalence facility at Taloja, Maharashtra, India. The facility stands UK-MHRA compliant. On 11 August 2016, Alkem Laboratories announced that the USFDA inspected the company's Bioequivalence facility at Taloja, Maharashtra, India from 1 August to 10 August 2016. At the end of the inspection, there were no 483s issued by the USFDA. On 28 October 2016, Alkem Laboratories announced that the USFDA conducted a Bio-analytical inspection at the company's manufacturing facility located at Daman, India from 24 October to 28 October 2016. The inspection has been cleared successfully without any 483 observations. This inspection was based on an ANDA filed by the company. On 7 February 2017, Alkem Laboratories announced that it has entered into an alliance with Haw Par India Pvt Ltd., a wholly owned subsidiary of Haw Par Healthcare Ltd., Singapore to exclusively market, sell and distribute Tiger Balm range of products in India. Tiger Balm products will be promoted by Alkem Healthcare, an Over the Counter (OTC) division of Alkem. Tiger Balm range of products is an internationally known remedy for headaches, upper respiratory congestions, rheumatic or arthritic pains and muscular sprains. Its unique blend of herbal ingredients, derived from an ancient Chinese source, has been proven effective for nearly 100 years and is trusted by millions of people in more than 100 countries. On 29 March 2017, Alkem Laboratories announced that the USFDA has issued an Establishment Inspection Report (EIR) for its Ankaleshwar API facility which was inspected in December 2016. The inspection has now been closed by the USFDA. The USFDA had inspected the Ankaleshwar API manufacturing facility from 5 to 9 December 2016 and had issued Form 483 with three observations. Post this, the company had submitted a detailed corrective and preventive action plan (CAPA) to the regulator within the stipulated timelines. The USFDA has reviewed the CAPA and has found them acceptable. On 10 January 2018, Alkem Laboratories announced the closure of USFDA inspection at its Baddi facility in Himachal Pradesh. On 28 March 2018, Alkem Laboratories informed the stock exchanges that the USFDA conducted an inspection at the company's manufacturing facility located at Amaliya, Daman, India from 19 March 2018 to 27 March 2018. Post the inspection, the company has received a Form 483 with thirteen observations. The company said it will put together a detailed response with adequate corrective and preventive measures to address the USFDA observations within the timeline stipulated by the USFDA. The USFDA also conducted an inspection at the company's manufacturing facility located at St. Louis, USA from 12 March 2018 to 16 March 2018. In response to the one Form 483 observation issued by the USFDA, the company has submitted a detailed corrective and preventive action plan (CAPA) plan to the regulator within the stipulated timelines. During the FY2019, the wholly owned subsidiary of the Company Alkem Laboratories (NIG) Limited was dissolved w.e.f. 06th May, 2018 pursuant to voluntary winding up. As on 31 March 2019,the company had 20 subsidiary companies under its roof. In FY 2018-19, the company invested Rs 4.62 billion or 6.3% of total revenues in R&D, compared to 5.7% in FY 2017-18. The company filed 23 ANDAs during the year and received 21 approvals, which includes 6 tentative approvals. The company have a fairly strong product pipeline of 127 ANDAs (as on 31st March, 2019) already filed with the USFDA, with over half of them yet to be commercialised. The Company has also made investments in the biosimilar segment through its subsidiary Enzene Biosciences - a biotech-focussed company located in Pune (Maharashtra, India). The company bagged Express Pharma Excellence Award at Pharma CXO Summit 2019. During the FY2020, a new company named Ascend Laboratories SAS was incorporated on 04th June, 2019 as a wholly owned subsidiary of the Company in Colombia. Also on 08th April, 2020, a new company named S&B Pharma LLC had been incorporated as a Step down subsidiary of the Company in USA. As on 31 March 2020,the company had 21 subsidiary companies under its roof. During the year 2019-20, the company invested Rs 4,726 million or 5.7% of total revenues in R&D, as against Rs 4,622 million in FY 2018-19. The company filed 18 ANDAs during the year and received 22 ANDA approvals which includes 6 tentative approvals. Alkem now has a total of 144 ANDAs (as on 31st March, 2020) filed with the USFDA and 89 approvals. During the quarter ended 30 June 2020, the Company filed 4 abbreviated new drug applications (ANDAs) with the US FDA and received 2 approvals (including 1 tentative approval). As on June 30, 2020, the Company filed a total of 146 ANDAs and 2 new drug applications (NDA) with the USFDA. Of these, it has received approvals for 88 ANDAs (including 13 tentative approvals) and 2 NDAs. During the quarter ended 30 September 2020, the Company filed 1 abbreviated new drug applications (ANDAs) with the US FDA and received 4 approvals (including 1 tentative approval). As on September 30, 2020, the Company has filed a total of 147 ANDAs and 2 new drug applications (NDA) with the USFDA of which it has received approvals for 91 ANDAs (including 13 tentative approvals) and 2 NOA. During the quarter ended 31 December 2020, the Company received 10 approvals (including 2 tentative approvals) from the USFDA. As on December 31, 2020, the Company has filed a total of 147 ANDAs and 2 new drug application (NDA) with the US FDA of which it has received approvals for 100 ANDAs (including 14 tentative approvals) and 2 NOA. In FY'20, Company started new formulation manufacturing facility in Indore and a new biologic / biosimilar manufacturing facility in Pune. S&B Pharma LLC has been incorporated as a step down subsidiary of the Company in USA on 08th April, 2020, and on 12th June, 2020, the Company acquired M/s Connect 2 Clinic Private Limited, a Company incorporated under the Companies Act, 2013. For business synergies, ease of administration and simplification in the organization structure for its business operations in USA market, the Company's Board of Directors at its meeting held on 25 May 2021 has approved the proposed plan for restructuring of the USA business operations by bringing both the subsidiary entities namely, S & B Pharma Inc, USA ('S & B') (engaged in manufacturing of pharmaceutical products and contract research) and The PharmaNetwork LLC, USA ('TPNC') (engaged in sales & marketing of pharmaceuticals products) under a single umbrella by removing intermediary holding company S & B Holdings BV, Netherlands ('S & B BV'). This Board approved restructuring is subject to necessary statutory and regulatory approvals. During the quarter ended 31 March 2021, the Company filed 4 abbreviated new drug applications (ANDAs) with the US FDA and received 10 approvals (including 3 tentative approvals). During the FY2021,the Company filed 9 ANDAs with the US FDA and received 25 approvals (including 6 tentative approvals). As on March 31, 2021, the Company filed a total of 150 ANDAs and 2 new drug applications (NDA) with the US FDA. Of these, it has received approvals for 108 ANDAs (including 16 tentative approvals) and 2 NDAs. In FY'21, First product was launched from Enzene Biosciences in India. The Company ventured into respiratory segment in India with the launch of Pulmocare division. Connect2Clinic, the Company's online platform for participating medical professionals and healthcare staff to connect with their patients, witnessed a significant surge in activity. In FY'21-22, Connect2Clinic crossed an important milestone of 1 lakh doctor consultations and is growing fast to become a preferred end-to-end OPD management platform in India. During the year 2022-23, Enzene Inc., was incorporated as a step down subsidiary of the Company in USA on 26th May, 2022 and Pharmacor Limited, incorporated as a step down subsidiary of the Company in New Zealand on 01st June, 2022. The Company launched Adalimumab in the domestic markets in 2023. A new Marketing and Sales division, Metanext was launched in the Chronic segment. In 2023-24, Company launched world's first biosimilar of Cetuximab, namely Cetuxa. It ventured into the trade generics segment. Alkem Medtech Private Limited, got incorporated on March 27, 2024, in India, as a wholly owned subsidiary of the company;