US FDA finds breaches at Sun Pharma’s Halol plant again

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Mumbai: India’s largest drugmaker Sun Pharmaceutical Industries Ltd on Wednesday said the US drug regulator had observed violations of good manufacturing practices at its Halol plant in Gujarat, less than two weeks after it found breaches of manufacturing standards at its Mohali plant in Punjab.

What’s worse, Sun Pharma had offered the plant for re-inspection recently after receiving a warning letter in 2015, and completing remediation work.

“We confirm that our Halol facility has undergone an inspection by US FDA recently. The inspection was completed on 1 December 2016. A Form-483 observation letter was issued by the US FDA post the inspection. We are currently in the process of responding to the said letter to the US FDA within the stipulated timeline of 15 days,” Sun Pharma said in a filing with stock exchanges.

ALSO READ:Sun Pharma’s Mohali unit violated manufacturing norms, finds US FDA

The US Food and Drug Administration (FDA) issues a Form 483 if its investigators spot any conditions that in their judgment may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related Acts. Sun Pharma did not give details on the number and nature of observations mentioned in the Form 483.

Shares of Sun Pharma fell 5.96% to Rs663.95 on BSE on Wednesday while the benchmark 30-share Sensex closed 0.59% lower at 26,236.87 points as the market feared the development will hurt the company’s sales in the world’s biggest pharmaceutical market. The company’s sales in the US were $2.07 billion in 2015-16, down 8% from a year ago.

Investors were hoping for a resolution of regulatory issues at the plant following positive comments from the company’s management regarding the remediation process.

The US drug regulator had issued a Form 483 to the company’s Halol plant in September 2014, citing 23 observations relating to deviations from manufacturing norms and issued a warning letter to the facility in December 2015.

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In a conference call with analysts after announcing September-quarter earnings, Dilip Shanghvi, managing director of Sun Pharma had said remedial steps have been taken at the Halol facility and the unit was ready for re-inspection. The company had invited the US FDA to re-inspect the Halol plant during the quarter ended June 2016.

“Most people believed that Halol unit will sail through the inspection this time. We still haven’t got the details on the nature of observations, whether they are minor or serious, but the fact that FDA made some observations has hurt market sentiment. This means that product approvals in the US will be delayed further, at least by three to six months,” said an analyst, who did not wish to be identified, citing company policy.

Last month, the FDA issued Form 483 with seven observations to Sun Pharma’s formulations plant at Mohali in Punjab, which originally belonged to Ranbaxy Laboratories Ltd, which Sun Pharma acquired in March 2015 for $4 billion. Sun Pharma is also struggling with regulatory issues at its Karkhadi unit and Ranbaxy’s facilities at Mohali, Dewas, Paonta Sahib and Toansa.