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US FDA lifts import alert imposed on Sun Pharma's Mohali facility

Move clears the way for supply of products from Mohali facility to the US market

BS B2B Bureau  |  Mumbai 

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The US Food & Drug Administration (FDA) will lift the imposed on Sun Pharma’s Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for to supply approved products from the Mohali facility to the US market, subject to normal US regulatory requirements.

The Mohali facility was inherited by as part of its acquisition of Ranbaxy Laboratories Ltd in 2015. The US had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility.

“This development illustrates Sun Pharma’s commitment to work closely with the US and strive for 100 percent cGMP compliance at its manufacturing facilities,” said in a press release.

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US FDA lifts import alert imposed on Sun Pharma's Mohali facility

Move clears the way for supply of products from Mohali facility to the US market

Move clears the way for supply of products from Mohali facility to the US market
The US Food & Drug Administration (FDA) will lift the imposed on Sun Pharma’s Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for to supply approved products from the Mohali facility to the US market, subject to normal US regulatory requirements.

The Mohali facility was inherited by as part of its acquisition of Ranbaxy Laboratories Ltd in 2015. The US had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility.

“This development illustrates Sun Pharma’s commitment to work closely with the US and strive for 100 percent cGMP compliance at its manufacturing facilities,” said in a press release.

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US FDA lifts import alert imposed on Sun Pharma's Mohali facility

Move clears the way for supply of products from Mohali facility to the US market

The US Food & Drug Administration (FDA) will lift the imposed on Sun Pharma’s Mohali (Punjab) manufacturing facility and remove the facility from the Official Action Initiated (OAI) status. This proposed action will clear the path for to supply approved products from the Mohali facility to the US market, subject to normal US regulatory requirements.

The Mohali facility was inherited by as part of its acquisition of Ranbaxy Laboratories Ltd in 2015. The US had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility.

“This development illustrates Sun Pharma’s commitment to work closely with the US and strive for 100 percent cGMP compliance at its manufacturing facilities,” said in a press release.

image
Business Standard
177 22