Sun Pharmaceutical Industries has received approval from regulators in the USA to market its generic versions of GlaxoSmithKline’s antidepressant Wellbutrin.
The US Food and Drug Administration has granted the Indian firm approval for its Abbreviated New Drug Application to market three strengths of Wellbutrin SR (extended-release bupropion). The three tablets have combined annual sales of approximately $300 million across the Atlantic and are indicated for the treatment of major depressive disorder.
Meantime, Livemint.com reports that Sun Pharma has now identified at least seven countries – Russia, China, Brazil, Mexico, Korea, South Africa and Japan – for the first phase of its new emerging markets initiative. The news service, which says the information comes from a company executive who did not want to be identified, says that Sun Pharma currently gets nearly 9% of its sales from these markets and has recently acquired manufacturing facilities in Mexico and Brazil.
Ranjit Kapadia, an analyst at HDFC Securities, is cited as saying that Sun Pharma needs to look at new markets “as its recovery in US sales may take an indefinite time” as its subsidiary there, Caraco Pharmaceutical Laboratories, “faces serious compliance issues”. Last summer, Caraco cut over half of its workforce as it felt the effect of the seizure by the FDA of $15-$20 million’s worth of drugs at its Michigan facility.
Mr Kapadia added that Sun “seems serious about these non-traditional markets now”, following the appointment last week of Kal Sundaram as chief executive. He will also have special responsibility for promoting emerging markets and will also hope to resolve Sun’s long-running battle to take over Israeli drugmaker Taro Pharmaceutical Industries.
