Natco products reach more than 40 countries globally. Key geographies include India, North America, Latin America, Asia Pacific, South East Asia & Middle East.Through our partneship driven model, our exports are primarily done by out-licensing our products to multinational companies and also those companies with strong local/ regional presence in the respective geographies.
We expect to continue growth by exporting niche & high value APIs & formulations. Our export business is supported by a strong in-house regulatory team. In addition to the partnerships, we operate in certain key geographies through our subsidiaries.
Natco has emerged a market leader in India’s generic oncology space led by flagship brands like Geftinat, Erlonat, Veenat and Sorafenat. The Company also heralded a new beginning in the gastro-hepatology therapy segment with the launch of Hepcinat portfolio that has brought a paradigm shift to the treatment and clinical outcome of Hepatitis-C. Most recently in 2017, the Company has entered a new therapy segment by launching a Cardiology and Diabetology (CnD) division which offers one of the highest prescribed DPP4 inhibitors and a comprehensive list of anti-hypertensives.
Our filings in the US are for intricate and niche products (either on our own or in collaboration with global pharmaceutical companies). Our finished dosages formulations (FDF) business is primarily focused on high-entry-barrier products that are either difficult to formulate and/or manufacture, typically resulting in limited competition in the market. As of March 31st 2017, we have made 43 ANDA filings with USFDA of which
(i) 19 are approved, including tentative; and
(ii) 24 are under review (including Paragraph III and Paragraph IV filings).
As of March 31st 2017, Natco currently supplies four products to the European market, three of which are Oncology formulation products. Natco has tied up with partners based in Europe for co-development of products and licensing of dossiers in the territory. Two of the companies’ plants have been inspected and approved by European Health Authorities.
Natco’s presence in RoW markets consists of Hepatitis C & Anti-Cancer formulation products. We have commercialised in some of the key markets such as Vietnam, Mongolia, Myanmar, Venezuela. Our reach into the RoW markets is done through following key channels - our subsidiaries; direct collaboration with local partners in a geography; global partners/distributors for a wider reach into several smaller geographies. Additionally, our aggressive business development activity in the emerging markets for the licensed Hepatitis C drugs will create new channels for growth.
Natcofarma do Brazil, a step down subsidiary of Natco India, commenced operations in 2011. Headquartered in Vitoria, it operates from 4 locations with 1 warehouse, a QC laboratory & a microbiological laboratory.
Backed by a strong portfolio of Oncology products we expect to file several products in the coming years along with a value speciality driven product pipeline for strong non-retail participation in local and major tenders.
Our distribution services are concentrated in the state of Espirito Santo offering our services to over 35 companies covering 1,200 SKUs. We are distributing products for about 30+ partners which are leading companies like Reckitt, Takeda, Actavis, Ranbaxy, Zydus, Uniao Quimica, EMS, Legrand, Geolab, Omron, Kley Hertz and Blowtex.
Natco Pharma Canada Inc., a wholly owned subsidiary was incorporated in the year 2012 with a backdrop of supplying quality medicines to the Canadian market through our partners for more than 5 years. Headquartered in Toronto, our main business model evolves with the registration, import and sale of pharmaceutical products supported by a strong local team varying from QA, RA, Warehousing, Sales force and with capabilities of releasing the products into the market from our own warehouse in Ontario.
We have 15 product approvals which are mainly from in-house products and also a few in-licensed products. We are the first company to launch the first generic version of Tamiflu® (Oseltamivir 75mg capsules) in the year 2016. With a knack of filing niche products such as the Oncology segment and to be among the first generic players is a key to our business model.
We expect to receive 4 approvals for our products which are under review at TPD, Health Canada in the year 2017. Driven by a rich speciality pipeline of new products we expect to file another 5+ products in the year 2017.
We were successful in listing our pharmaceutical products with major retail chains and provincial formularies in Canada which entitled us to receive better market share for our products.
Natco Pharma Asia Pte was established in the year 2014. It is headquartered in Singapore. The subsidiary is involved in the registration and direct sales of Natco’s products in Singapore market. Natco Pharma Asia Pte has received approvals from Health Sciences Authority (HSA) for 5 niche products targeted for Breast Cancer, Blood Cancer and Supportive Care in Cancer Treatment. Currently 5 of our other niche Oncology Products are under review by HSA.
Natco Australia Pty Ltd has been incorporated in the year 2014. The subsidiary is involved in registration and out licensing of NATCO’s products in Australia and New Zealand Markets. Currently 2 of our key Oncology Products are under review by Therapeutic Goods Administration (TGA).
Mr. Subba Rao Mente
Vice President - Global Generics