 "FDA ban: Ranbaxy to take 'appropriate action' for lapses at Toansa")
Ranbaxy Laboaratories today saidit will take ‘appropriate management action’ for the lapses atthe manufacturing facility after the conclusion of an internalinvestigation.
The company is disappointed with the recent US Food andDrug Administration (USFDA) action and would like to apologiseto all its stakeholders for the inconvenience caused by thesuspension of shipment, Ranbaxy Laboratories said in astatement.
“This development is clearly unacceptable and anappropriate management action will be taken upon completion ofthe internal investigation,” Ranbaxy CEO and Managing DirectorArun Sawhney said.
[caption id=“attachment_903475” align=“alignleft” width=“380”]  Reuters[/caption]
USFDA has notified the company that it is prohibited frommanufacturing and distributing active pharmaceuticalingredients (APIs) from its facility in Toansa, India, forFDA-regulated drug products, it said.
The US health regulator had earlier this month issued theForm 483 to the company for its Toansa plant in Punjab forviolations of the current good manufacturing practice (CGMP).“Subsequent to the Form 483 issued in early January 2014,Ranbaxy voluntarily and proactively suspended shipments of APIfrom this facility to the US market when it received theinspection findings,” the company said.
Ranbaxy’s other key facilities at Ponta Sahib (HimachalPradesh) and Dewas (Madhya Pradesh) are already under an USimport alert since 2008. Last year, its other key facility atMohali also came under USFDA import alert.
“With this import alert, the operations of the company inUS business which contributes around 40 per cent could comeunder impact, unless it can compensate for the same at theearliest and mange a smooth supply of key raw material,” AngelBroking VP - Reasearch Pharma Sarabjit Kour Nangra said.
Shares of Ranbaxy were trading at Rs 351.50 apiece on theBSE, down 15.74 percent from its previous close.
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