Nectar Lifesciences (NecLife), a leading US$ 200 million integrated pharmaceutical organization, has received ‘Certificate of Suitability’ for its key sterile (injectable) molecule cefuroxime sodium in European Union (EU). The company has already received EU cGMP approval for cefuroxime sodium in October 2011.
The cefuroxime sodium marketed by innovator GSK as Zinacef in EU & US as injectable. The total market size of molecule is estimated at US$ 500 million, of which European sales constitute approximately 35 per cent (US$ 175 million). This translates into a significant opportunity for the company as NecLife is indisputably one of the largest global player in cephalosporins which includes cefuroxime sodium (sterile) in terms of production capacity for APIs.
NecLife has already developed formulations for cefuroxime inj. (750 mg & 1.5 g) has already filed ANDA for US & very soon file MAA in EU in current financial year.
Dinesh Dua, CEO & director of Nectar Lifesciences, said, “ The ‘Certificate of Suitability’ grant for cefuroxime sodium (sterile)in the EU is a testimony to the efforts made by the company to increase our reach and further entrench presence in the regulated markets. We believe we are well poised to take advantage of the opportunities the new markets have to offer. We are also confident of our ability to further augment our position in the cephalosporin market in three major molecules and are making stable progress towards securing approvals in other key markets whilst delivering healthy growth.”
NecLife offers specialised comprehensive range of oral and sterile cephalosporins and semi-synthetic penicillin active pharmaceutical ingredients (APIs) and finished dosage forums (FDFs).