Natco Pharma Ltd

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company that specialises in development, manufacturing and marketing of Finished Dosage Formulations (FDF) and Active Pharmaceutical Ingredients (APIs). The Company's focus is primarily on niche therapeutic areas and complex products. It sells products in over 40 countries. FDF products are sold in the United States, India, Europe and the rest of the world (RoW). Natco's API products are primarily used for captive consumption in its FDF products and are also sold to customers for various international markets such as Brazil, Europe and USA. In the API segment, Natco has capabilities to develop and manufacture products with multi-step synthesis, semi synthetic fusion technologies, high-potency APIs and peptides. Natco Pharma is also engaged in contract manufacturing business, whereby the company undertakes selected contracts with pharmaceutical companies to manufacture and supply pharmaceutical products. Natco Pharma was originally incorporated on 19 September 1981 as private limited company under the name of Natco Fine Pharmaceuticals Private Limited. It became a deemed public company with effect from 1 July 1992. The name of the company was changed to Natco Pharma Limited and a fresh certificate of incorporation consequent upon change of name was issued by the RoC, Andhra Pradesh on 18 February 1993. The company was converted into a public limited company and a fresh certificate of incorporation dated 30 December 1994 was issued by the RoC, Andhra Pradesh. In 1988, the company inaugurated a Parenterals manufacturing facility at Nagarajuna Sagar, Telangana. In 1993, the company inaugurated its chemical division at Mekaguda, Telangana. On 1 April 1995, Natco Parenterals Limited, Natco Laboratories Limited and Dr. Karanth Pharma Labs Private Limited merged with Natco Pharma. In 1997, Natco Pharma inaugurated Natco Research Center (NRC) at Sanathnagar, Hyderabad. In 2003, Natco Pharma launched its Oncology division with introduction of flagship brand VEENAT (generic Imatinib Mesylate) for the treatment of chronic myelogenous leukemia. In 2006, Natco Pharma inaugurated a world class finished dosage facility at Dehradun, Uttarakhand. In 2007, Natco Pharma launched its first abbreviated new drug application (ANDA) in the US market. During the year, the company acquired Savemart Pharmacy in USA. In 2008, Natco Pharma filed its first Paragraph IV filing in the US market. In 2009, Natco Pharma's turnover reached $100 million milestone. In 2011, Natco Pharma and Levomed LLC, USA formed a joint venture company, Natcofarma Do Brasil for sales and distribution in Brazil. In 2012, Natco Pharma won the first ever compulsory license from Bayer for its patent-protected anti-cancer drug Nexavar in India. During the year, the company established Natco Pharma Asia Pte Ltd as a wholly owned subsidiary for sales and distribution in Singapore. In 2013, Natco Pharma established a subsidiary Natco Pharma Canada for sales and distribution in Canada. In 2014, Natco Pharma established a subsidiary Natco Pharma Australia Pty Ltd for sales and distribution in Australia. On 9 March 2015, Natco Pharma announced that it has launched the first generic version of sofosbuvir in Nepal. Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc., under its brand Sovaldi. On 11 March 2015, Natco Pharma announced that it is the first company in India to get approval for generic sofosbuvir tablets, 400mg, from Drugs Controller General (India). Natco will market generic sofosbuvir under its brand HEPCINAT and through strategic partners in India. The Board of Directors of Natco Pharma at its meeting held on 30 March 2016 approved the sale of its Save Mart Pharmacy Store located in the USA to CARE MART Inc. The Save Mart Pharmacy Store is owned by Natco Pharma Inc., a wholly owned subsidiary of the company, and is considered as a non-core part of the business. On 12 December 2016, Natco Pharma announced the launch of the first generic version of Oseltamivir oral capsules, 30 mg, 45 mg and 75 mg through its marketing partner Alvogen in the USA market. In 2017, Natco Pharma launched new cardiology and diabetology division for Indian market. On 2 January 2017, Natco Pharma announced that it has launched the first generic version of Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination in Nepal. Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination is sold by Gilead Sciences, Inc., under brand name Epclusa. Epclusa is the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for Ribavirin. On 17 May 2017, Natco Pharma announced that its partner Dr. Reddy's Laboratories Ltd. has received approval from the U.S. Food and Drug Administration (USFDA) to launch Doxorubicin Hydrochloride Liposome Injection, a therapeutic equivalent generic version of Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market. On 5 October 2017, Natco Pharma announced that its marketing partner Mylan N.V., has launched in the U.S. the first Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection that is an AP-rated substitutable generic version of Teva's Copaxone 40 mg/mL, as well as Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone 20 mg/mL. These products are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. Shipments to customers have commenced. On 4 November 2017, Natco Pharma announced that it has executed definitive agreement and subscribed to 7.50% of the paid-up equity share capital of OMRV Hospitals Private Limited (OMRV). The investment amount was Rs 7.50 crore. OMRV operates under brand name of PACE Hospital which is a super specialty hospital presently operating in Hyderabad, Telangana focused on tertiary care services in the field of Medical and Surgical Gastroenterology, Hepatology, Nephrology, Urology, GI Oncology and Andrology. The Committee of Directors of Natco Pharma at its meeting held on 14 December 2017 approved allocation of 1 crore Equity Shares at the issue price of Rs 915 per Equity (including a premium of Rs. 913 per Equity Share) upon the closure of the issue, to eligible qualified institutional buyers pursuant to the QIP amounting to an Issue size of Rs 915 crore. On 17 February 2018, Natco Pharma completed regulatory inspection from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India, which was conducted during the period 12th February, 2018 to 16th February, 2018, where the regulatory audit resulted in zero observations (no form 483 issued). During FY 2019-20, NATCO had 8 launches in the domestic market, 5 in cardiology and diabetology segment, and 3 in oncology segment. It launched a combination drug Vildanat M (Vildagliptin and Metformin) for diabetes, to achieve better blood glucose control and improve therapy compliance. During the period 2019-20, NATCO Life sciences Philippines Inc. was formed a fully owned subsidiary in the Philippines. During the year, it launched an FDC of Sofosbuvir-Daclatasvir tablets to treat Hepatitis C under the brand name 'Hepcinat Plus' and an oral fixed-dose combination of Sofosbuvir and Velapatasvir under their brand 'Velpanat'. The Company has 7 subsidiaries as on March 31, 2020. The Company has 7 international subsidiaries including 1 step-down subsidiary as on 31st March, 2021. In FY 2020-21, the Company launched generic Lenalidomide in South Africa. The Company has 8 international subsidiaries including 2 step-down subsidiaries as on 31st March, 2022. During FY 2021-22, Company through NATCO Pharma Inc., USA a wholly owned Subsidiary of Company acquired Dash Pharmaceuticals LLC, USA effective on 1st January, 2022, where Dash Pharmaceuticals LLC, USA is a step-down wholly owned Subsidiary Company of the Company. In Philippines, it launched first product, Liposomal Doxorubicin. In Australia, it received approval for Lenalidomide and Pomalidomide. It launched Sorafenib tablet in Taiwan with one year exclusivity. It launched first generic of Abiraterone tablets in Taiwan & Indonesia. It launched the Bendamustine Injection and Anastrozole tablets by the subsidiary named, Natco Lifesciences Philippines Inc. It launched the first generic of Oseltamivir in Brazil. It launched Everolimus in the US market. It launched 4 new products launched in 2021-22 such as Xpreza tablets, Pazonat, Cazanat and Tipanat for pateints suffering from liver, kidney and colorectal cancer. 11 new products launched in 2022-23. The Company launched Chlorantraniliprole (CTPR) pesticide formulation and its combination products in liquid and granule forms. It launched a first generic alternative to the cancer drug Pomalidomide capsules sold under the Pomalyst brand; launched Apixaban, Azacitidine in Philippines, Gefitinib, launched Oseltamivir capsules in the China market in 2023. It launched two Chlorantraniliprole (CTPR) pesticide formulation under brand names NATGEN and NATERRA and CTPR combination products under the brand names NATVOL and NATLIGO. It launched the first generic of Nat-Pomalidomide, Nat-Apixaban, and Nat-Teriflunomide in the market in the year 2023.