Chandigarh-based Nectar Lifesciences Limited (NecLife) 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, for its Drug Master File — Cefuroxime Axetil, NecLife received the confirmation of approval on September 7.
The US market for Cefuroxime Axetil is currently valued at $50 million and NecLife being the most integrated player globally stands to benefit with this approval through its associates.
Neclife’s API facility at Unit-II, 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.
These approvals will help the company build and sustain the growth delivered by its API business by tapping the more profitable regulated markets. So far, NecLife has filed 21 Drug Master Files in highly regulated markets and six Abbreviated New Drug Applications.
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The company expects to file another 20 DMFs and 10 ANDAs/EU Dossiers from Dera Bassi and Baddi facilities in this fiscal year.
It is worth mentioning that NecLife, a leading integrated pharmaceutical organisation in India, offering a specialised comprehensive range of oral and sterile cephalosporin and Carbapenem active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). The Company is growing presence in empty hard gelatine capsules (EHGCs) and menthol products.