STOCK MARKET BSE NSE

US FDA issues 12 observations on Biocon units

Biocon does not expect any change to its commercialisation plans for insulin glargine in the US.

Published: 09th July 2019 11:34 AM  |   Last Updated: 09th July 2019 11:34 AM   |  A+A-

Biocon CMD Kiran Mazumdar-Shaw

Biocon CMD Kiran Mazumdar-Shaw ( File Photo | EPS)

By Express News Service

HYDERABAD: Biotechnology major Biocon on Monday said that the US FDA had issued 12 observations after the inspection of three of its units in Malaysia.

Biocon Sdn Bhd’s insulin glargine drug substance, drug product and device assembly facilities in Malaysia had a pre-approval inspection by the FDA between June 24 and July 5, Biocon said in a filing with BSE.

“The inspection across these three units concluded with 12 observations issued on Form 483,” it added.

Form 483 notifies the company of objectionable conditions.

“We will respond to the FDA with a corrective and preventive action plan and are confident of addressing these observations expeditiously,” the statement said.

Biocon does not expect any change to its commercialisation plans for insulin glargine in the US.

Stay up to date on all the latest Business news with The New Indian Express App. Download now

Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp