WOCKHARDT LIMITED

Wockhardt Limited, incorporated in July, 1999 is a global pharmaceutical and biotechnology organization, providing affordable, high-quality medicines for a healthier world. The Company is India's leading research-based global healthcare enterprise in fields of Pharmaceuticals, Biotechnology and a chain of advanced Super Speciality Hospitals. It has 12 manufacturing locations and there are 3 locations where research and development activities are carried out. The Company has manufacturing and research facilities in India, USA & UK and a manufacturing facility in Ireland. It has a significant presence in USA, Europe and India, with 83% of its global revenues coming from international businesses. Wockhardt is the only company in the world where USFDA has given QIDP Status (Qualified lnfectious Diseases Programme) for 5 of Anti-bacterial discovery programmes - 2 of them are Gram Negative and 3 Gram Positive effective against untreatable 'Superbugs'. Wockhardt's entire anti-infective portfolio particularly addresses the specific bacterial organism where resistances are high and breakthrough antibiotics are needed. In 2000, the company launched the cardiac drug enalapril maleate in the US through their marketing joint venture with Sidmak Laboratories. Also, they set up a corporate training centre with modern and state-of-the-art facility under one roof at Aurangabad. In the year 2001, the company terminated their three-year old marketing alliance with Sidmak Laboratories, one of the top ten generic Pharma companies in the US. Also, they entered into a strategic alliance with a Japanese firm Eisai Company Ltd to manufacture and market a neurology drug Methycobal. In the year 2003, the company restructured their field organization to upgrade their competitiveness and productivity, launched new four speciality hospitals at their Mulund complex in Mumbai. Also, they acquired CP pharmaceuticals (Holdings) Ltd, along with their subsidiaries. The company launched Asia's first human recombinant insulin, making India the first Asian country to develop, manufacture and market the product. Also, they received USFDA approval for marketing bethanecol Chloride tablets in the US. In the year 2004, the company acquired the German pharmaceutical company esparma GmbH for a consideration of Rs 49 crore. Also, they got USFDA nod for 6 manufacturing units. In February 2005, the company launched India's first automatic insulin delivery device specially designed for the convenience of Indian diabetic patients. The company forged alliance with Kamineni Group to establish two world-class heart hospitals in the Hyderabad. Also, they received US FDA approval for marketing cefuroxime axetil in the US market. In the year 2006, the US FDA had approved the company's Waluj plant. In the year 2007, the company signed in-licensing pact with Crawford Healthcare of UK. They acquired Negma Laboratories, which is the fourth largest independent, integrated pharmaceutical groups in France, for an all-cash deal worth $ 265 million. In October 2007, they acquired the Morton Grove Pharmaceuticals, a leading liquid generic and speciality dermatology company in the US. Also, they inked an in-licensing agreement with the Italy-based Gnosis, to market SAMe (S-adenosyl methionine). In the year 2008, the company approved demerger of their Research & Development business into a separate entity. Also, they launched the Cetirizine tablets in the USA. The company received the ANDA from the US FDA for marketing the tablets containing 5mg and 10mg Cetirizine Hydrochloride. In February 2008, they received approval from the US FDA for marketing the tablets containing 250 mg, 500 mg and 600 mg Azithromycin. In August 2008, the company received tentative approval from the US FDA to make and sell Sumatriptan Succinate injection, in the strength of 6-mg/0.5 ml. During the period January 2009 to March 2010, the company received 22 ANDA approvals and launched eight new products, thereby expanding their product basket to 87. During the period, the company divested Animal Health Care Division to Vetoquinol, France. The business of Esparma GmbH was also divested to Mova GmbH. During the year 2010-11, the company launched a total of 43 new products in India. In April 2011, as per the scheme of arrangement, the Nutrition Business of Vinton Healthcare Ltd, a wholly owned subsidiary of the company was demerged into the company. The appointed date for the Scheme is January 1, 2011. In January 2012, the company received final approval from the United States Food & Drug Administration (US FDA) for marketing 50 mcg nasal spray of Fluticasone which is used in treatment of allergic rhinitis. In 2012, the company launches generic version of anti--ulcer drug Prevacid. The company also receives US FDA approval for generic version of Parkinsonism drug Requip XL. The company receives tentative US FDA approval for generic version of anti-psychotic drug Geodon. The company also receives US FDA approval for generic version of Parkinson's drug Comtan. In 2013, the company Wockhardt receives the 'Best Enterprise' award from the Europe. The company launches launches generic version of anti-convulsant drug Lamictal XR. In 2015, the company receives ANDA Approval for pain medication Oxycodone liquid. The company also receives Qualified Infectious Disease Product (QIDP) designation for its new Drug WCK 4873 from U.S. FDA. US FDA grants breakthrough (QIDP) drug discovery status to the New Antibiotic of Wockhardt. On 15 January 2016, Wockhardt Ltd informed the stock exchanges that inspection of its manufacturing unit at E-1/1, MIDC, Shendra, Aurangabad by US FDA has since been completed. US FDA has made 9 observations for which appropriate reply would be submitted to inspecting authority in due course. Shendra manufacturing unit is a new facility and presently there is no supply of products from the said Unit to USA markets. On 1 July 2016, Wockhardt Ltd informed the stock exchanges that the Company has given Corporate Guarantee to secure Term loan of US$ 250 Million facility availed by Wockhardt Bio AG, a subsidiary of the Company. On 8 August 2016, Wockhardt informed the stock exchanges that U.S. Food and Drug Administration (USFDA) has updated Import Alert 66-40 on its website on Wockhardt's API (Active Pharmaceutical Ingredients) unit located in Ankleshwar, Gujarat. The company has already initiated required steps to address the concerns raised by USFDA and putting all efforts to resolve the matter. With reference to the earlier letter dated 8 August 2016 regarding Update on Import Alert 66-40 by US FDA on Wockhardt's API Unit at Ankleshwar, Gujarat, Wockhardt Ltd informed the stock exchanges on 3 October 2016 that U.S. Food and Drug Administration (USFDA') on 30 September 2016 has posted on its website an update on the above referred matter and excluded the product 'Ceftriazone Sodium' from Import Alert. This will enable the Company to manufacture and sell Ceftriazone API and formulation to US market. The Board of Directors of Wockhardt at their Meeting held on 10 November 2016 approved the acquisition of 100% stake in Wockhardt France (Holdings) S.A.S. (WFH') (an existing step down subsidiary of the Company) from Wockhardt Bio AG (WBG'), a subsidiary of the Company. By virtue of the said acquisition, WFH shall become a direct wholly owned subsidiary of the Company from erstwhile step down subsidiary. WBG continues to be a direct subsidiary of the Company. On 23 November 2016, Wockhardt informed stock exchanges that U.S. Food and Drug Administration ('USFDA') has issued a Warning Letter to C P Pharmaceuticals Limited, Wrexham, United Kingdom, a stepdown Subsidiary of the Company. Currently, there is no business being conducted from C P Pharmaceuticals to the US Market. C P Pharmaceuticals has already initiated required steps to address the concerns raised by USFDA and will be responding to the Agency within the prescribed time. On 13 December 2016, Wockhardt informed the stock exchanges that UK MHRA has since confirmed that the Company's manufacturing unit at Kadaiya, Daman complies with the principles and guidelines of Good Manufacturing Practices. In view of this, the approval status of the said unit continues. On 19 December 2016, Wockhardt informed the stock exchanges that UK MHRA has since confirmed that general compliance with the principles and guidelines of Good Manufacturing Practice of the Company's manufacturing unit at L-1, Chikalthana, Aurangabad. In view of this, the approval status of the said unit continues. Further, UK MHRA has considered the said manufacturing unit suitable for Risk based Inspection with reduced inspection frequency of 2 years from the existing inspection frequency of 1 year. On 5 January 2017, Wockhardt informed the stock exchanges that competent authority, Berlin, Germany has since issued EU GMP Certificate confirming that Company's manufacturing facility at 138, GIDC Estate, Ankaleshwar, Gujarat, complies with the principles and guidelines of Good Manufacturing Practices. The Certificate issued in this regard is valid for 3 years. On 1 March 2017, Wockhardt informed the stock exchanges that the U.S. Food and Drug Administration ('USFDA') has issued a Warning Letter to Morton Grove Pharmaceuticals Inc., USA, a stepdown Subsidiary of the Company. This would mean that current portfolio of the Company will continue to be made available in the market. However, new approvals will be withheld till resolution. The Company, with the help of the Consultants, has already initiated appropriate measures since last several months to address the issues raised by USFDA. On 3 April 2017, Wockhardt announced that in a recent meeting between Wockhardt Research team and US FDA New Drug Antibiotic Regulatory team, US FDA agreed to abridged clinical trial for Phase III for Wockhardt's superdrug antibiotic WCK 5222.This was based on the evaluation by US FDA of its preclinical and clinical data of Phase I establishing safety and clinical scope of efficacy for the drug. WCK 5222 is a combination of Zidebactam and Cefepime. On 29 May 2017, Wockhardt Limited (WL) announced that the Health Products Regulatory Authority of Ireland ('HPRA') has granted Certificate of GMP Compliance to the company's Shendra, Aurangabad facility based on inspection performed from 27 February 2017 to 3 March 2017. On 22 June 2017, Wockhardt Limited (WL) announced that, WL and two subsidiaries, Wockhardt UK Holdings Limited and CP Pharmaceuticals Limited (CP), in the United Kingdom have settled an ongoing commercial litigation before the High Court in London, United Kingdom in related to a supply contract for a drug named Trisenox. The dispute between the parties was in respect of the price charged by CP to its counterparty to the contract, Cephalon Inc, (Cephalon) an affiliate of Teva Pharmaceuticals USA, Inc. (Teva). Under the above referred settlement between the parties, CP has agreed to waive its claim for the outstanding trade receivable of GBP 20 mn and accordingly dropped its counterclaim for the said amount and further paid a sum of GBP23 mn to Teva and Cephalon by way of full and final settlement of Teva's claims. The High Court has accepted the settlement between the parties and a Consent order was issued on 21 June 2017. On 7 August 2017, Wockhardt Limited announced that it has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 1gm, and 2gm injections of Oxacillin.Oxacillin is a penicillanase-resistant beta-lactam antibiotic and is used to treat many different infections caused by penicillin-resistant Staphylococcal and other bacterial infections, such as Urinary Tract Infections, Respiratory Tract Infections, Septicemia, Wound Infection, Bacterial meningitis etc. Wockhardt is expected to launch this product in the United States, soon. The product is being manufactured at a contract manufacturing facility, based near Milan, Italy. The Board of Directors of Wockhardt Limited at its meeting held on 4 May 2018 approved raising of additional capital by way of one or more public or private offerings including through a Qualified Institutions Placement (QIP) to eligible investors through an issuance of equity shares or other eligible securities for an amount not exceeding Rs 1500 crore as may be permitted under applicable law and subject to applicable regulatory and statutory approvals. With an aim to grow and further establish its international presence in pharmaceutical manufacturing, Wockhardt set up its first facility in Middle East for manufacturing of NCEs (New Chemical Entities) catering to the global markets through its Dubai arm of its subsidiary Wockhardt Bio AG in July 2018. In FY 2019, US Food and Drugs Administrator (US FDA) carried out inspection of Bioequivalence Centre located at R&D Centre, Aurangabad during which Bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol Tartrate 200mg ER tablets were audited. As on 31March, 2019, the Company has total 32 Subsidiaries under its roof. During the year, the Company has incorporated 'Wockhardt Medicines Limited' as a Wholly Owned Subsidiary of the Company. As on 31 March, 2020, Wockhardt has, cumulatively, filed 3,165 patents, and has been granted 722 patents cumulatively. The Board of Directors of your Company in their meeting held on 12 February, 2020 approved the transfer of business comprising 62 products and line extensions along with related business assets and liabilities, contracts, permits, intellectual properties, employees, marketing, sales and distribution of the same in the Domestic Branded Division in India, Nepal, Bhutan, Sri Lanka and Maldives and manufacturing facility in Baddi, Himachal Pradesh, India, where some of the above pharmaceutical products which are being transferred are manufactured (Business Undertaking') by way of a slump sale to Dr. Reddy's Laboratories Limited as per the terms and conditions specified in the Business Transfer Agreement (BTA') for a consideration of Rs 1,850 crore. Wockhardt, on 03 August 2020 entered into an agreement with the UK Government to fill finish COVID-19 vaccines for which manufacturing will be undertaken at CP Pharmaceuticals, a subsidiary of Wockhardt based in Wrexham, North Wales. As per the terms of the agreement the company has reserved manufacturing capacity to allow for the supply of multiple vaccines to the UK Government in its fight against COVID-19, including AZD1222, the vaccine co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed by AstraZeneca. 8 patents were filed during the quarter ended 30 September, 2020 and the cumulative filings are stood at 3173. The company was granted 14 patents during the quarter and now holds 742 patents as on 30 September 2020. 9 patents were filed during the quarter ended 31 December, 2020 and the cumulative filings are stood at 3182. The company was granted 10 patents during the quarter and now holds 752 patents as on 31 December 2020. On 10th February 2021, Wockhardt announced six-month extension of its agreement with the UK Government to fill-finish COVID-19 vaccines. This expands the original agreement from 18 to 24 months i.e., until August 2022 and the manufacturing will continue to be undertaken at CP Pharmaceuticals, a subsidiary of Wockhardt based in Wrexham, North Wales. 5 patents were filed during the quarter ended 31 March 2021 and the cumulative filings are stood at 3187. The company was granted 11 patents during the quarter and now holds 763 patents as on 31 March, 2021. During the year 2021, Company launched 2 new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia. During the year 2021, Company transferred the business comprising 62 products and line extensions along with related assets and liabilities, contracts, permits, intellectual properties, employees, marketing, sales and distribution of the same in the Domestic Branded Division in India, Nepal, Bhutan, Sri Lanka and Maldives, and manufacturing facility at Baddi, Himachal Pradesh, where some of the products which are being transferred were manufactured (together the Business Undertaking), to Dr. Reddy's Laboratories Limited (DRL) for a consideration of Rs. 1,850 crore, subject to adjustments specified in the Business Transfer Agreement (BTA) dated 12th February 2020. During the year 2021, Wockhardt France (Holdings) S.A.S. (WFH), a Step down Subsidiary of the Company divested the Marketing Authorisations (MAH) of the products along with their Trademarks (collectively known as Business Assets') for a consideration of Euro 11 Million. During the year 2022, the Company has filed 41 patent applications and 40 patents were granted during the year of which 36 patents were for NCEs. Accordingly, as on 31st March, 2022, the Company has cumulatively filed 3,228 patents and grants 803 patents . During the year 2022, Wockhardt Bio AG - a subsidiary of Wockhardt Limited and Jiangxi Jemincare Group Company Limited, China have partnered for Wockhardt's novel patented antibiotic WCK 4873 in People's Republic of China, Hong Kong, Macau and Taiwan for the treatment of community-acquired bacterial pneumonia and other respiratory tract infections. It launched EMROK and EMROK O in India and treated over 20,000 patients. Phase 3 study involving patients with complicated urinary tract infections started in October 2022. The Company launched its next generation reusable insulin delivery device mypen 2', an ISO 10993 and 11608-certified product with a European design in 2024. It introduced the Mako SmartRoboticsT System for knee and hip replacement surgeries. It also completed the pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873 in 2024.