The company is disappointed with the recent US Food and Drug Administration (USFDA) action and would like to apologize to all its stakeholders for the inconvenience caused by the suspension of shipment, Ranbaxy Laboratories said in a statement.

"This development is clearly unacceptable and an appropriate management action will be taken upon completion of the internal investigation," Ranbaxy CEO and Managing Director Arun Sawhney said.

READ MORE: FDA bans more products from Ranbaxy

USFDA has notified the company that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products, the company said.

US health regulator had earlier this month issued Form 483 to the company for its Toansa plant in Punjab for violations of the current good manufacturing practice (CGMP).

"Subsequent to the Form 483 issued in early January 2014, Ranbaxy voluntarily and proactively suspended shipments of API from this facility to US market when it received the inspection findings," the company said.

Ranbaxy’s other key facilities at Ponta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) are already under an US import alert since 2008. Last year, its other key facility at Mohali also came under USFDA import alert.

"With this import alert, the operations of the company in US business which contributes around 40 per cent could come under impact, unless it can compensate for the same at the earliest and mange a smooth supply of key raw material," Angel Broking VP - Research Pharma Sarabjit Kour Nangra said.

Ranbaxy stock nosedives 20 percent
 
Shares of Ranbaxy Laboratories slumped as much as 20 percent in the morning trade after the USFDA restrictions.
     
After a weak opening, shares of the drug firm further tumbled 19.69 percent to Rs 335 on the BSE. On the NSE, the stock dived 19.75 percent to Rs 335. The company's market value tanked by Rs 3,156 crore to Rs 14,520 crore.

(Agencies)

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