US FDA approval for API plant – Nectar Lifesciences Ltd.
Nectar Lifesciences has received US Food and Drug Administration’s approval for its active pharmaceutical ingredients manufacturing plan. Nectar Lifesciences Ltd. announced that it has received US Food and Drug Administration’s (USFDA) approval for its Active Pharmaceutical Ingredients (APIs) manufacturing plant Unit-II in Dera Bassi, Punjab. Followed by the recent audit of USFDA in June 2011 for its Drug Master File – Cefuroxime Axetil, NecLife received the confirmation of approval on September 7, 2011. NLL’s API facility at Unit-ll, Dera Bassi has also been approved by Japan MOH, MCC South Africa and Korean FDA. NecLife’s API as well as Formulations Facility have both been successfully inspected by EU authorities and are awaiting final approval.