Nectar Lifesciences, a leading integrated pharmaceutical organization, has been granted ‘Certificate of Suitability’ for its key sterile molecule Cefuroxime Sodium in European Union (EU). The company already has EU cGMP approval for Cefuroxime Sodium, which was granted in October, 2011.
Cefuroxime Sodium is marketed by Innovator GSK as ZINACEF TM in EU and US as injectable is a $500 million molecule globally, of which, European sales constitute approximately 35% ($175 million). This translates into a significant opportunity for the company as indisputably one of the largest global player in cephalosporins which includes Cefuroxime Sodium in terms of production capacity for APIs.
The company already has developed formulations for Cefuroxime injections (750 mg and 7.5 g) and has already filed ANDA for US and will very soon file MAA in EU in current financial year.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1858.70 |
Dr. Reddys Lab | 1258.55 |
Cipla | 1559.20 |
Lupin | 2198.25 |
Zydus Lifesciences | 1004.00 |
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