US FDA’s 6 observations for Cipla’s Patalganga unit drags firm’s shares down 1.5%

Cipla’s Patalganga plant manufactures active pharmaceutical ingredients (APIs), the key raw materials for medicines, as well as formulations.

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Troubles rose again for Cipla Ltd as the US Food and Drug Administration slapped a form 483 with six inspectional observations on the drugmaker’s manufacturing facility at Patalganga in Maharashtra. The continued regulatory stress for the company sent its shares down 1.5 percent in early trade on April 5.

At 9.19 am, shares of Cipla were trading at Rs 1,450.95 apiece on the NSE.

Cipla’s Patalganga plant manufactures active pharmaceutical ingredients (APIs), the key raw materials for medicines, as well as formulations. The US drug regulator had conducted a routine current Good Manufacturing Practices (cGMP) inspection of the unit in question between March 28-April 4.

The company responded by stating its commitment to collaborating closely with the US FDA and ensuring that it addresses the observations within the specified timeframe.

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Two of Cipla’s other major units in Goa and Pithampur are already caught in regulatory issues, which has resulted in delay in launches of two blockbuster drugs for the company, namely respiratory medication Advair and chemotherapy medication Abraxane.

The delay in launches of these two major drugs amid regulatory challenges at respective facilities responsible for their production has caused monetary loss for the drugmaker.

On that account, regulatory issues at another facilities has weighed on investor sentiment even more.

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