Text Size A A A

Sun Pharma In The News

Tell a Friend Print Home » Media » Sun Pharma In The News

Sun Pharma's US Facility gets FDA Approval


Sun Pharmaceuticals, which makes many gener­ic and brand name drugs that are distributed in the United States, Europe, Asia and worldwide, have got a shot in the arm from the US Food & Drug Ad­ministration (FDA) which has approved manufac­turing at the company's unit inCranbury New Jer­sey. Manufacturing at the unit had been stopped af­ter FDA issued warnings regarding inconsistent quality, packaging defects and the presence of un­known impurities on Au­gust 25 last year.
Reacting to the develop­ment, a company spokes­man said: "FDA had not asked us to stop manufac­turing, but we did so our­selves till it was resolved." The Cranbury facilityman-ufactures lifestyle disorder products such as cardiac medicines. However, they do not contribute signifi­cantly to revenue, the com­pany spokesman added.
Sun Pharma's US oper­ations include four manu­facturing sites including one of Caraco, a company that Sun Pharma first bought shares in 1997.
Now, three are operation­al, but Caraco's plant in Detroit is yet to be inspect­ed. In 2004, Sun Pharma in­creased stake in Caraco to over 60% from 44% for $42 million. Then, it bought back shares of Caraco to delist the company in No­vember last year as busi­ness became stagnant af­ter FDA shut down the manufacturing plant. Caraco is now a fully-owned subsidiary of Sun Pharma, and it develops, manufactures and distrib­utes generic and private-label pre­scription drugs to wholesal­ers, dis­tributors, drugstore chains, health­care sys­tems as well as state and federal agencies. The US accounts for 38% of Sun Pharma's total sales, which were Rs.1,636 crore in the first quarter of the financial year that be­gan in April. The compa­ny's revenue in financial year that ended in March 2010 got affected due to low­er sales in the US due to ob­jections raisedby FDA that forced the company to stop manufacturing