Pharma in 2014: Deals Worth Billions and Fines Worth Millions


Otherwise too, both Sun and Ranbaxy had to face their own issues with the U.S. health regulator FDA for alleged violation of good manufacturing practice norms.

A number of other Indian drugmakers, including IPCA Labs, Wockhardt and Dr Reddy's Laboratories were also pulled up by the FDA for one or the other reasons.

The FDA imposed a ban on import of medicines produced at Ranbaxy's India-based factories into the US, the world's biggest drug market.

Ranbaxy also agreed to pay $39.75 million (around Rs 244 crore) in tranches to the state of Texas in the US to settle the litigation concerning its participation in the Texas Medicaid Program.

Its woes extended to Europe when it was barred from exporting certain antibiotics from its Dewas plant to Germany for non-compliance to 'good manufacturing practise' norms.

Later, certain drugs produced at its Dewas plant were barred from export to the entire European Union for non-compliance to 'good manufacturing practise' norms.

Further, a U.S. court did not grant the company temporary restraining order to block the U.S. health regulator from approving other ANDAs for generic versions of digestive disorder medicine Nexium and anti-viral Valcyte.

Ranbaxy Laboratories had sued USFDA over revoking an approval to sell generic versions of Nexium and Valcyte in the U.S. market.

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Source: PTI