Sun Pharmaceutical Industries Ltd. is looking to launch new products from its Halol plant, which recently gained clearance from the U.S. Food and Drug Administration.
Previously, the regulator had repeatedly rejected lifting the import restrictions on the plant, which is the company's main manufacturing facility responsible for new product launches in America.
Following the plant's clearance, India's biggest drugmaker is planning to introduce its epilepsy therapy Elepsia and Xelpros, an eye drop for treating glaucoma, in the U.S.
"Xelpros may be launched during the course of this year. Elepsia, I am still contemplating how much we can take on our plate, because in the U.S. some of these launches are all clustered in a couple of quarters. Whether we take it on as a cluster or we stagger it a little is something I have still not made up my mind about," Abhay Gandhi, CEO of the company's North America business, said on the company's earnings call for the first quarter of fiscal year 2019.
Dilip Shanghvi, Sun Pharmaceutical's managing director, said the company has already started applying for approvals for its products from the Halol plant.
"We have started getting some potential goal dates during the year as well as some time even in the beginning of next year. So depending on when and how these goal dates start coming we expect to start getting the approval of the products." Shanghvi said on the call.
These would add to the company's plans to launch its skin disorder therapy Ilumya in the second quarter and dry eye treatment Seciera in the later part of the fiscal year.
The Mumbai-based company also benefitted from the improvement in the U.S., its biggest market, where first-quarter sales increased 8% year over year to US$380 million.
"Generic Welchol has clearly been a contributor but a lot of our other products have also done well," Gandhi told analysts regarding the growth in the U.S. business.
Launched in May, Sun Pharmaceutical has exclusive rights to distribute a generic version of Tokyo-based Daiichi Sankyo Co. Ltd.'s cholesterol-lowering drug, Welchol.
The company is also anticipating higher costs for the launch of its specialty products such as Ilumya and Seciera and expects overall research and developed spending to be 8% to 9% of total sales in fiscal 2019.
"Although we have built the front end infrastructure for the specialty business in the U.S., there would be specific marketing and other costs at the time of launch of these products. They will entail high upfront investment," Gandhi said.
When asked whether the company will provide specialty product breakdown going forward, Shanghvi, who has termed the business as the company's new engine of growth, said he will take the suggestion for consideration.
"We will keep your suggestion for sharing more transparently the separate cost and bifurcation between the generic and branded business. It's something that we will consider and if we feel that they are still in the interest of the shareholders then we will start sharing bifurcated costs," Shanghvi said.
The company's shares closed at 601.8 Indian rupees on Aug. 14, up 6.72% from its previous day close on the Bombay Stock Exchange, according to data from S&P Global Market Intelligence.
As of Aug. 13, US$1 was equivalent to 69.99 rupees.