“A challenging US generic pricing environment coupled with continued investments in building our global specialty business has impacted our Q2 performance,” Dilip Shanghvi, managing director of the company, said in a statement.
Sun Pharma invested Rs511 crore, or 7.7% of its sales, in research and development (R&D) in the September quarter.
This includes investments on account of funding the clinical development of its global specialty pipeline, the company said.
In a conference call with analysts, Shanghvi said a delay in the approval of certain important products in the US due to regulatory issues at the company’s manufacturing unit in Halol, Gujarat, has also affected US business.
The US Food and Drug Administration (FDA) had issued a warning letter to the Halol unit in December 2015 for violation of good manufacturing practices. Since then, new product approvals have been held back by the regulator. “There are no new updates on Halol. We are awaiting re-inspection from the US FDA. Site transfers for some products from the facility ongoing,” Shanghvi said.
The company’s sales in the US, which contributed 30% to the total revenue, fell 44% to $309 million in the quarter due to pricing pressure in existing products and lower contribution from generic of cancer drug Gleevec.
In the same period last year, Sun Pharma had benefited from marketing exclusivity for Gleevec generic.
Sun Pharmaceutical Industries Ltd, India’s largest drug maker, reported a 59.7% decline in fiscal-second quarter profit because of weak US sales.
Sun Pharmaceutical Industries Ltd, India’s largest drug maker, reported a 59.7% decline in fiscal-second quarter profit because of weak US sales.
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