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 Brasil, a step down subsidiary of Natco India, commenced operations in 2011. It operates under three business entities - Pharmaceuticals, OTC and Distribution services. The Pharmaceutical division undertakes registration and importation of pharmaceuticals. Backed by a strong portfolio of Oncology products we expect to file niche products in the year 2017 along with a value speciality-driven product pipeline for strong non-retail participation in local tenders and major tenders like PDP to follow for the years to come.
Natco Pharma Canada Inc., a wholly owned subsidiary was incorporated in the year 2012. Headquartered in Toronto supported by a strong local team comprising of QA, RA and Sales force. We have a total of 15 product approvals (including in-licensed products). We are the first company to launch the first generic version of Oseltamivir capsules in the year 2016. Driven by a pipeline of new products we expect to file several speciality products in the year 2017.
Headquartered in Singapore, the subsidiary is involved in the registration and direct sales of NATCO’s products in the Singapore market.
• Received approvals from Health Sciences Authority (HSA) for five niche products
• Products targeted for breast cancer, blood cancer and supportive care in cancer treatment
• Five of our other niche Oncology products are under review by HAS
Incorporated in September 2014, the subsidiary is involved in the registration and out-licensing of NATCO’s products in the markets of Australia and New Zealand.
• Two of our key Oncology products are under review by the Therapeutic Goods Administration (TGA)
Mr. Subba Rao Mente
Vice President - Global Generics