In spite of a major regulatory clampdown on its US subsidiary, Caraco, Mumbai-based Sun Pharmaceuticals is trying hard to keep its US market share intact. The company is relying on its own manufacturing facilities to deliver goods to the US market. All eight ANDAs (abbreviated new drug applications) for sales permission in the US filed during the first quarter of the current financial year (Q1FY2010) came from Sun’s facilities.
Between Sun and its subsidiaries, ANDAs for 73 products have been approved while ANDAs representing 111 products await drug regulator USFDA’s approval. Caraco had a fair share of these filings. Of the cumulative filings for 58 products from Caraco, ANDAs for 25 products are pending USFDA’s approval.
“We continue to get approvals for products from Sun Pharma facilities in India and the US, which remain fully cGMP (current good manufacturing practice) compliant. During Q1FY2010, Sun Pharma received four final approvals and three tentative approvals from such facilities,” said a Sun pharma spokesperson.
Sun, which earns 35 per cent of its revenues from the US, the world’s biggest drug market, had seen sales decline 24 per cent on a quarter-to-quarter basis during the first quarter of the current financial year. The fall in sales was primarily due to a 56 per cent decline in revenues of Caraco after the US drug regulator ordered seizure of medicines manufactured at the subsidiary’s Michigan facilities.
Within days, Caraco announced an indefinite reduction in its workforce of approximately 350.
Even though Sun is determined to see that new product introductions in the US are not delayed due to Caraco’s woes, the company is yet to decide on external sourcing of medicines produced at the Michigan facility. “Caraco will need to decide this, though sourcing from other facilities is quite time-consuming and effort-intensive, which could take away resources from addressing the priority on hand,” said a Sun official.
“Caraco will need to decide this, though sourcing from other facilities is quite a time-consuming and effort-intensive process, which could take away resources from addressing the priority on hand,” a Sun official said.
Following the US regulatory action, Sun pharma had withdrawn its growth guidance of 10-15 per cent a month ago.
