Moneycontrol
Apr 16, 2018 05:32 PM IST | Source: Moneycontrol.com

Cipla gains 5% after USFDA inspection with no data integrity or repeat observations

The US Food and Drug Administration has recently completed its inspection of Cipla's Indore facility.

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Cipla-InvaGen/Exelan acquisition | Year: September 2015 | Deal size: USD 550 million Objective: To scale-up US generics business and have manufacturing presence in that market. Results: The InvaGen/Exelan buy has expanded Cipla’s US base, but failed to deliver on the commercial potential of limited competition filings such as generic Renvela and generic Fosrenol. Since the acquisition, Cipla has already taken USD 110 million of impairments on the acquisition, which accounts for nearly 20 percent of the acquisition cost. (Image: Reuters)
Cipla-InvaGen/Exelan acquisition | Year: September 2015 | Deal size: USD 550 million Objective: To scale-up US generics business and have manufacturing presence in that market. Results: The InvaGen/Exelan buy has expanded Cipla’s US base, but failed to deliver on the commercial potential of limited competition filings such as generic Renvela and generic Fosrenol. Since the acquisition, Cipla has already taken USD 110 million of impairments on the acquisition, which accounts for nearly 20 percent of the acquisition cost. (Image: Reuters)
 
 
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Cipla was the biggest gainer among Nifty50 stocks after CNBC-TV18 reports quoting sources that the US health regulator has not issued any data integrity or repeat observations for Indore unit. The stock price closed at Rs 583.55, up 5.22 percent on the BSE.

The US Food and Drug Administration has recently completed its inspection of Cipla's Indore facility.

CNBC-TV18 quoting Cipla said the USFDA has not issued data integrity or repeat observations for the unit and there is nothing adverse to report w.r.t the unit.

The US health regulator started inspecting Cipla's Indore unit from April 2, 2018.

Indore, a formulations manufacturing facility, had earlier received nine observations from the USFDA in 2015 and which were cleared in 2016.

In January 2018, the US FDA had conducted a product specific pre-approval inspection at Goa plant and issued certain observations which were procedural in nature. Post that inspection, it had received two product approvals from the plant.

Meanwhile, Cipla said the board, on May 22, will consider and approve audited financial results (standalone and consolidated) for the quarter and year ended March 31, 2018 (FY18) and recommendation of dividend, if any.
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