Zydus Lifesciences Ltd

Zydus Lifesciences Ltd. (Formerly known as Cadila Healthcare Ltd.) is one of the leading innovation driven pharmaceutical companies in India with presence across the pharmaceutical value chain includ ... ing innovating (research & development), manufacturing, marketing and selling of finished dosage human formulations (generics, branded generics and specialty formulations, including biosimilars and vaccines), active pharmaceutical ingredients (APIs), animal healthcare products and consumer wellness products. The Company has their manufacturing facilities at Ahmedabad, Ankleshwar and Vadodara in Gujarat, Ponda in Goa, Raigad in Maharashtra and Solan in Himachal Pradesh. Founded by the Late Promoter, Mr. Ramanbhai B. Patel, the Company was incorporated in May, 1995 and converted into a Public Limited Company in July, 1996. The Company's operation includes pharmaceuticals, which includes human formulations, veterinary formulations and bulk durgs, diagnostics, herbal products, skin care products and OTC products. In the year 1996, the Company made a strategic alliance with Gulin Pharma of China and launched Falcigo in India, which is an anti-malarial segment. In May 2000, the company acquired formulation business of Recon Ltd, which strengthens the company in the southern market. In the year 2001, they acquired German Remedies which was the largest M&A in the Indian Pharmaceutical sector and in the same year, they entered into a joint venture with US based Onconova for collaborative research in the field of Oncogenomics. In April 2002, the Company acquired Banyan Chemicals, a Vadodara based company with the US FDA approved plant. In the year 2003, German Remedies, Recon Healthcare, Zoom Properties and Zydus Pathline merged with the company. Also, they acquired Alpharma France, which spearheaded the group operations in France. In the same year, the company emerged as a 'Partner of Choice' for Schering AG to manufacture and market the products in India. In November 2004, the Company entered into a strategic alliance with Zambon Group in Italy to open up new avenues in contract manufacturing. In the same year, it signed a long term strategic pact with Boehringer Ingelheim India Ltd, a wholly owned subsidiary of Boerhringer Ingelheim (BI) to manufacture and market BI's products in India. In the year 2005, the Company entered into a strategic alliance with Mallinckrodt Pharmaceuticals Generics, a business unit of Tyco Healthcare to market the product manufactured by the company under a joint label. In the same year, the company signed a 50:50 joint venture with Mayne Pharma of Australia to manufacture generic injectable, cytotoxic (anti-cancer) medicines as well as active pharmacetical ingredients (API) for global markets. During the year 2005-06, the Company signed a 50:50 joint venture with one of India's top biotech companies Bharat Serums and Vaccines Ltd (BSV) and formed Zydus BSV Pharma Pvt Ltd to develop, manufacture and market non-infringing and proprietary Novel Drug Delivery System (NDDS) of an approved anti-cancer product for global markets. During the year 2006-07, the company entered into share purchase agreement to acquire 97.95% stake in Liva Healthcare Ltd, which is carrying on business of manufacturing and marketing of Formulations. They established a green field facility for Solid Oral Dosage Forms in Sikkim mainly for domestic market. They also installed Lyophilisation facility at Moraiya plant with annual capacity of 7.5 million dosages to cater to both Indian and International markets. During the year 2007-08, the company restructured their formulation division namely Alidac and launched two new sub division namely Corza and Fortiza. Also, they forayed into the neutraceutical industry and launched a new division, Zydus Nutriva. The upgradation of the injectibles facility at Moraiya was completed and also, they expanded their manufacturing facility at Ankleshwar. Zydus Healthcare Brasil Ltd, Brazil, a wholly owned subsidiary of the company, acquired 100% shareholding of Quimica e Farmaceutica Nikkho Do Brasil Ltda, a Brazilian Pharmaceutical company, to expand their branded business in Brazil. Also, Zydus Pharmaceuticals Inc, Japan, a wholly owned subsidiary of the company, acquired 100% shareholding in Nippon Universal Pharmaceuticals Co Ltd, Japanese Company, which is carrying out business of manufacturing and marketing of pharmaceutical products in Japan. In February 2008, the company and Karo Bio of Sweden made a three year strategic collaboration in the area of drug discovery and development. In May 2008, the company entered into Spain with the acquisition of 100% stake in Laboratories Combix. In June 2008, the company through their wholly owned subsidiary, Zydus Healthcare SA Pty Ltd is acquiring majority state of 70% in Simayla Pharmaceuticals of South Africa. The company decided to demerge the Consumer Products Division of the company and transferred to Carnation Nutra Analogue Foods Ltd, which is a subsidiary of Cadila Healthcare and the merger of Zydus Hospital and Medical Research Pvt Ltd with the company. In August 2008, the company entered into an agreement with WHO to explore a possible collaboration in the development of a cocktail for the treatment of rabies, through the use of monoclonal antibodies. The Board of Directors of Cadila Healthcare and Carnation Nutra-Analogue Foods Ltd. at their respective meeting held on 4 July 2008 approved the modalities of the composite scheme of arrangement for restructuring of the consumer products division of Cadila Healthcare. The board approved the demerger of the consumer products division of Cadila Healthcare into Carnation, which is a subsidiary of Cadila Healthcare and the merger of Zydus Hospital and Medical Research Pvt. Ltd. (ZHMRPL) with Cadila Healthcare. As consideration, Carnation will allot to the shareholders of Cadila Healthcare 4 fully paid-up equity shares of Rs 10 each for every 15 equity shares of Rs 5 each held in Cadila Healthcare. On 28 January 2011, Cadila Healthcare and Bayer HealthCare announced that they have signed an agreement to set up the Joint Venture Company Bayer Zydus Pharma for the sales and marketing of pharmaceutical products in India. Each party will hold 50 percent of the shares of Bayer Zydus Pharma, headquartered in Mumbai, and be equally represented on its management board. Bayer Zydus Pharma will start operations with Bayer HealthCare's Pharmaceutical Division contributing its existing sales and marketing business in India to the new company and Cadila Healthcare contributing its women's healthcare products, diagnostic imaging business and other products. Bayer Zydus Pharma will operate in key segments of the Indian pharmaceuticals market with a focus on women's healthcare, metabolic disorders, diagnostic imaging, cardiovascular diseases, anti-diabetic treatments and oncology. On 17 June 2011, Cadila Healthcare announced that Zydus Pharmaceuticals USA Inc., through its subsidiary Zynesher Pharmaceuticals USA LLC has entered into an agreement to acquire the assets of the US based pharmaceutical company Nesher Pharmaceuticals Inc. Nesher operates as the generic subsidiary of KV Pharmaceutical, based at St. Louis, Missouri, USA. The financial details of the agreement were not disclosed. Nesher has considerable expertise in niche therapies which have development or production barriers, such as controlled release medications or DEA-controlled substances. The broad-based assets purchase agreement includes assets and assumption of certain liabilities, Nesher's existing and pipeline ANDAs, certain manufacturing facilities and a full fledged research and development lab. With this, Zydus will now be able to manufacture and distribute generic controlled substances in the US market, which otherwise cannot be imported. On 1 April 2011, Cadila Healthcare announced that it has ended the financial year 2010-11 on a high note, taking its revenues beyond the $1 billion mark. On 27th July 2011, Cadila Healthcare announced that its 100% subsidiary Zydus Animal Health Limited (AHL) has signed a Share Purchase Agreement with ICICI Venture, to acquire 100% shareholding of Finest Procuring Solutions Limited, which in turn holds 100% shareholding of Bremer Pharma GmbH, of Germany. The agreement includes the transfer of all key assets, people, brands and export contracts of Bremer - a global animal health company headquartered in Warburg-Scherfede, Germany. The acquisition will help Zydus AHL expand its animal health business and gain strategic access to the key markets across Europe, South America, Asia and Africa. On 21 December 2011, Cadila Healthcare announced the acquisition of 100% stake in Biochem, one of the top 40 pharma companies in India. A privately-held company headquartered in Mumbai, Biochem is a well-integrated pharma player with a presence in the antibiotics, cardiovascular, anti-diabetic and oncological segments. Biochem has reported sales of Rs 264.5 crore for the year 2010-2011. On 18 July 2012, Zydus Urosciences, the specialty division of Cadila Healthcare, announced the launch of Udenafil, a next generation therapy for erectile dysfunction, for the first time in India. The group has an exclusive license to market this patented molecule developed by Dong-A Pharmaceuticals of Korea, in India. On 25 July 2013, Cadila Healthcare and IDRI, a Seattle-based non-profit research and product development organization, announced that they are collaborating on the production and clinical development of IDRI's visceral leishmaniasis (VL) vaccine candidate, designed to prevent the deadly parasitic disease. Known as Kala-Azar in India, VL is transmitted by the bite of an infected sand fly. Cadila Healthcare and IDRI will collaborate to conduct clinical development activities in India with the goal of developing, registering and marketing this vaccine candidate for the prevention of VL, which will achieve the objective of global access - that is, ensuring the vaccine is affordable to and accessible by all people in need. Conducting trials in India, where there are real-life situations of disease exposure, is critical to determining the effectiveness of IDRI's VL vaccine candidate and ensuring it is approved and available within endemic countries. On 16 October 2013, Cadila Healthcare and Pieris AG, a next generation therapeutic protein R&D company, announced that they have entered into an alliance for development and commercialization of multiple novel Anticalin-based protein therapeutics. The collaboration combines Pieris' drug discovery and early development capabilities with Cadila's expertise in biologics development, regulatory affairs and biologics manufacturing. Under the terms of the agreement, Cadila Healthcare will take the lead in advancing Anticalin drug candidates through formal preclinical development and into clinical development, undertaking drug development in accordance with ICH guidelines. Cadila Healthcare has been granted exclusive marketing rights in India and several other emerging markets, while Pieris retains exclusive marketing rights in key developed markets. On 15 September 2014, Cadila Healthcare and Gilead Sciences, Inc. announced that they have signed a non-exclusive licensing agreement which will allow the generic manufacture of sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 90 developing countries, including India. Under the licensing agreement, Cadila Healthcare will receive a complete technology transfer of the Gilead manufacturing process to enabling production to be scaled up as quickly as possible. Zydus will set its own prices for the generic product, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other business essential activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines. On 9 December 2014, Cadila Healthcare announced that it has become the first company in the world to launch the biosimilar of Adalimumab - the world's largest selling therapy. Developed by the researchers at the Zydus Research Centre, the biosimilar has been approved by the Drug Controller General of India and will be marketed under the brand name, Exemptia to treat auto immune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosing Spondylitis. On 17 March 2015, Cadila Healthcare announced the launch of SoviHep - the breakthrough therapy for Hepatitis C in alliance with Gilead Sciences, Inc. SoviHep will provide succour to more than 10 million patients who suffer from Hepatitis C in India. The therapy will be marketed by the specialty division of the group, Zydus Heptiza. Zydus and Gilead Sciences, Inc. had signed a non-exclusive licensing agreement which will allow the manufacture of sofosbuvir and the fixed-dose combination of ledipasvir/sofosbuvir for distribution in 91 countries including India. On 31 December 2015, Cadila Healthcare announced that the company has received a warning letter by the USFDA relating to its Moraiya formulation facility and Ahmedabad API facility (Zyfine). In a statement, Cadila Healthcare said that the company is working hard to ensure that the commitments made to the USFDA are fully completed. The company will continue to take all necessary steps to ensure that the USFDA is fully satisfied with the company's remediation measures for these two manufacturing facilities. There are no products in the US market which use API of Zyfine facility. On 5 January 2016, Cadila Healthcare announced the strategic acquisition of select brands and the manufacturing operations in Haridwar, India, of Zoetis, a global animal health company. The acquisition will help Cadila Healthcare expand its animal health business in India and gain access to manufacturing operations which have also been catering to global markets. The financial details of the deal were not disclosed. As a result of this acquisition, Cadila gains access to a wide range of nutrition as well as therapeutic products which have strong brand equity and a combined turnover of Rs 171 crore. A major boost to the company's portfolio would be the addition of livestock farmcare products which are well accepted in the market. An access to the WHO GMP approved manufacturing facility is expected to boost Cadila's exports and institutional business. The plant spread over 10,000 sq. metres manufactures Tablets, Liquid Orals and Injectables. On 19 February 2016, Cadila Healthcare announced that it has received approval from the USFDA to market Doxycycline Capsules USP, 50 mg, 75 mg, and 100 mg. The drug falls in the anti-bacterials segment. With this first approval, the group will now commence supplies to the US market from its formulation manufacturing facility located at the SEZ in Ahmedabad. On 28 March 2016, Cadila Healthcare announced that its wholly owned subsidiary Zydus Healthcare Limited has entered into a definitive agreement to acquire Actibile' from Albert David Limited (ADL). The brand falls in the gastroenterology segment and is used for dissolving gall bladder stones. The deal will be financed through internal accruals. On 15 June 2016, Cadila Healthcare announced that it has signed a strategic collaboration agreement with Eczacibasi Ila Pazarlama A.S. a leading healthcare company of Turkey, to market biotech products in the Turkish market. The agreement involves the import of biosimilars which are currently unavailable in the country especially for the treatment of cancer and also paves the way for a long term strategic collaboration to produce and launch new products in the market. On 20 June 2016, Cadila Healthcare announced that it has strengthened its US portfolio with the acquisition of two ANDAs from Teva that are being divested by Teva as a pre-condition to its acquisition of Allergan's generic business. The acquisition of these ANDAs is contingent on the closing of the Teva-Allergan Generics transaction and approval by the US Federal Trade Commission. The financial details of the transaction were not disclosed. These ANDAs have been acquired by its 100% subsidiary, Zydus Worldwide DMCC and the transaction will be financed through internal accruals. The acquired portfolio comprises an ANDA which is already commercialised and one pipeline ANDA which is a transdermal patch. The estimated market size of the two ANDAs put together is nearly US$ 200 million. On 7 July 2016, Cadila Healthcare announced that it has signed a non-exclusive, royalty free agreement with The Medicines Patent Pool (MPP) for the generic production of Bristol-Myers Squibb's daclatasvir, a novel direct-acting antiviral (DAA) that is proven to help cure multiple genotypes of the Hepatitis C Virus (HCV). The agreement sub-licences Cadila to produce and sell daclatasvir in 112 low and middle income countries. The MPP licence allows generic manufacturers to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of HCV. On 20 September 2016, Cadila Healthcare and Takeda Pharmaceutical Company Limited announced a partnership to tackle chikungunya, an emerging infectious disease. The chikungunya virus is most often spread to people by Aedes aegypti and Aedes albopictus mosquitoes, the same vectors that spread dengue and zika. The broad-based agreement includes early stage development to the final commercialisation of the vaccine. There is currently no vaccine to prevent or medicine to treat chikungunya virus infection. On 30 September 2016, Cadila Healthcare and Medicines for Malaria Venture (MMV) announced a collaboration to develop the investigational antimalarial compound MMV674253. Cadila Healthcare will lead the development of the novel compound and MMV will provide support including scientific expertise and access to tools in the field of malaria drug development and delivery. The aim of the collaboration is to provide an effective alternative to the current front-line antimalarial drugs for the treatment of uncomplicated P. falciparum malaria, artemisinin-based combination therapies (ACTs), which are under threat of resistance. On 28 December 2016, Cadila Healthcare announced that its wholly owned subsidiary company Zydus Healthcare Limited (Zydus) has acquired six brands from MSD and its subsidiaries. The brands are DECA-DURABOLIN, DURABOLIN, SUSTANON, MULTILOAD, SICASTAT and AXETEN range, which fall in the men's health, women's health, wound management and cardiovascular therapy segments, respectively. The deal includes transfer of distribution and commercialization rights and assignment of trademarks of all the six brands to Zydus Healthcare Limited in India. As a part of the deal, Organon (India) Private Limited, one of the legal subsidiaries through which MSD operates its business in India, has also transferred the distribution and commercialization rights for DECA-DURABOLIN and DURABOLIN to Zydus for Nepal. Financial details of the deal were not disclosed. The strategic brands' acquisition will strengthen Cadila's portfolio in key therapeutic segments. The acquired portfolio had clocked sales of Rs 84 crore in 2015. On 19 January 2017, Cadila Healthcare announced that it has acquired Sentynl Therapeutics Inc., a US based specialty pharma company specialized in marketing of products in the pain management segment. The transaction will be EPS accretive. With this acquisition, Cadila Healthcare makes a foray into the specialty pain market in the US valued at $8 billion. It gains access to the specialty distribution network and a large prescriber base. Sentynl provides healthcare professionals with treatment solutions that enable them to meet the needs of individual patients. This acquisition will also enable Cadila Healthcare to leverage its existing assets in the US. The acquisition was solely funded by Bank of Tokyo-Mitsubishi UFJ. On 23 February 2017, Cadila Healthcare announced that the USFDA has approved the group's plans to initiate a Phase 2 clinical trial of Saroglitazar Magnesium (Mg) in patients with Primary Biliary Cholangitis (PBC) of the liver. This randomized, double-blind Phase 2 trial will evaluate Saroglitazar Magnesium 2mg and 4 mg Vs. Placebo. PBC is a liver disease caused due to progressive destruction of the bile ducts in the liver which leads to reduction of bile flow - a condition referred to as cholestasis. On 24 February 2017, Cadila Healthcare announced that it has received approvals from the Drug Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO) and the Central Drug Laboratory (CDL) to market the Tetravalent Inactivated Influenza vaccine for seasonal flu, VaxiFlu - 4. With this, Cadila will become the first Indian pharma company and second in the world to launch a Tetravalent Inactivated Influenza vaccine. The vaccine provides protection from the four influenza viruses- H1N1, H3N2, Type B (Brisbane) and Type B (Phuket). VaxiFlu - 4 will be marketed by Zydus Vaxxicare - a division of the group focussing on preventives. On 21 June 2017, Cadila Healthcare announced that its formulations manufacturing facility at Moraiya, Ahmedabad has received an Establishment Inspection Report (EIR) from the USFDA signifying the successful closure of the audit. The Moraiya manufacturing plant had completed the USFDA audit from 6 February to 15 February 2017 with zero 483 observations. Post the audit, the plant has received several product approvals, including the final approval to market Mesalamine Delayed- Release Tablets USP, 1.2 g in the US. On 5 July 2017, Cadila Healthcare announced the initiation of a phase II trial investigating ZYAN1, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a treatment for anemia associated with chronic kidney disease (CKD). ZYAN1 is an oral small molecule that has been designed to inhibit hypoxia-inducible factor prolyl hydroxylase, and thereby increase the natural production of hemoglobin and RBCs in anemic patients. ZYAN1 has been shown to improve iron mobilization and has the potential to reduce or eliminate the need for iron supplementation. On 5 July 2017, Cadila Healthcare and Phibro Animal Health Corporation announced their intention to enter into a long-term arrangement to license Phibro's innovative poultry vaccine technologies and know-how to a new vaccine manufacturing facility to be built by Cadila to serve the fast growing poultry market in India. The availability of new advanced poultry vaccines, which were until now being imported into India, adds a new dimension to the Make-in-India movement in the animal health segment. On 12 July 2017, Cadila Healthcare announced its succession planning move with the appointment of Dr. Sharvil Patel as the managing director of the company. While Mr. Pankaj Patel will continue as the Chairman of the company, he has stepped down as the Managing Director. On 29 August 2017, Cadila Healthcare announced that its formulations manufacturing facility at Pharma SEZ, Ahmedabad has received an Establishment Inspection Report (EIR) from the USFDA signifying the successful closure of the audit. The manufacturing plant had completed the USFDA audit from 16 to 24 January 2017. On 7 September 2017, Cadila Healthcare announced that the USFDA inspected its Moraiya facility from 31 August 2017 to 7 September 2017. At the end of the inspection, no observation (483) was issued. On 19 September 2017, Cadila Healthcare announced that it has entered into an exclusive agreement for the technology know-how for varicella vaccine production in the Russian Federation with Pharm Aid Ltd., headquartered in Russia. The exclusive agreement was signed at the BIOTECHMED conference in Gelendzhik, Russia. Pharm Aid Ltd, has been set up by Nacimbio together with Ishvan Pharmaceuticals Ltd., for the localization of innovative vaccine production in Russia. Through this agreement, Cadila Healthcare gains access to the public and private market segments in the Russian Federation, Belarus, Uzbekistan, Kazakhstan, Armenia and Kyrgyzstan. On 29 November 2017, Cadila Healthcare announced that the company has entered into a public private partnership with the Indian Council of Medical Research (ICMR) to launch new diagnostic kits, developed by ICMR's National Institute of Virology (NIV), Pune to detect neglected infectious diseases in livestock. The kits have been developed to detect infections in the animal population, as they often are the hosts or reservoirs, spreading the infection to humans who come in close contact with them. On 9 February 2018, Cadila Healthcare announced that the USFDA inspected its Moraiya facility from 5 February to 9 February, 2018. At the end of the inspection, no observation (483) was issued. On 8 March 2018, Cadila Healthcare announced that it has entered into a definitive agreement with Medicure International Inc., a subsidiary of Medicure Inc. (Medicure) to commercialize its 505(b)(2) New Drug Application (NDA) product, pitavastatin magnesium (ZYPITAMAGTM) in the United States. The launch of ZYPITAMAG, which is used to manage cholesterol levels, marks the first branded product launch for the company in the US. Medicure is a US pharmaceutical company and has a proven track-record of successful commercialization of products in the therapeutic segments of cardiovascular and metabolic diseases. As a part of this agreement, Cadila Healthcare will hold the NDA and Medicure will be responsible for the sales and marketing of ZYPITAMAG. On 28 March 2018, Cadila Healthcare announced that the USFDA inspected its Topical manufacturing facility located at Changodar, Ahmedabad from 22 March to 28 March 2018. At the end of the inspection, no observation (483) was issued. During the year 2021, Zydus Discovery DMCC (ZDD), a subsidiary of the Company completed Phase II clinical trials of Saroglitazar Magnesium for Primary Biliary Cholangitis (PBC) indication. USFDA granted the Orphan Drug Designation (ODD) and Fast Track Designation to Saroglitazar Magnesium in the treatment of patients with Primary Biliary Cholangitis (PBC). The Company launched its first biosimilar viz. Pegfilgrastim in Russia. It launched 30 new products in the US generics market. It commenced commercial manufacturing from 2 more areas of Oral Solid Dosage formulations manufacturing facility located in Ahmedabad SEZ. The Company improved the capacity of Goa formulations facility by 25% by de-bottlenecking granulation area through improvement in cycle time of key products. In year 2022, Zydus Animal Health and Investments Limited (ZAHL), a wholly owned subsidiary of the Company disposed of its Animal Healthcare Established Markets Undertaking to Zenex Animal Health India Private Limited (Purchaser), by way of a slump sale, at a lump sum consideration of Rs. 29,210 million, and consequently, transaction of sale and disposal of the Undertaking was closed on July 14, 2021. A molecule was launched in India in March, 2022 under the brand name, 'Oxemia'. It launched Ujvira, (Trastuzumab Emtansine biosimilar) in India, which is the first biosimilar of an Antibody Drug Conjugate (ADC) Kadcyla and a highly effective drug for treating both early and advanced HER2 positive breast cancer. It received a tentative approval from the USFDA for a New Drug Application (NDA) for Sitagliptin base tablets. During the year, 2022 Sentynl entered into an asset purchase agreement with BridgeBio Pharma for acquisition of NULIBRY (Fosdenopterin) for Injection to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultrarare, life-threatening paediatric genetic disorder. Read More