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Nectar Lifesciences manufacturing unit gets US FDA nod
Nectar Lifesciences has received US Food and Drugs Administration (FDA) approval for its Active Pharmaceutical Ingredients (API) manufacturing plant Unit-II in Dera Bassi, Punjab.
Nectar Lifesciences has received US Food and Drugs Administration (FDA) approval for its Active Pharmaceutical Ingredients (API) manufacturing plant Unit-II in Dera Bassi, Punjab.
Nectar Lifesciences hit the 20% upper circuit at Rs 23 on NSE post the announcement in afternoon trade.
This facility has also been approved by Japan's ministry of health, Medical Control Council of South Africa and Korean FDA, Nectar Lifesciences said Thursday.
The company's API as well as formulations facilities have been successfully inspected by European Union authorities and it is awaiting final approval from them, it said.
Nectar Lifesciences said these approvals will help it tap the more profitable regulated markets and thus sustain the growth delivered by its API business.
The company aims to file 20 drug master files (DMF) and 10 abbreviated new drug applications (ANDA) from its Dera Bassi and Baddi facilities in the current fiscal. So far it has filed 21 DMFs and 6 ANDAs in highly regulated markets, Nectar Lifesciences said.
