Nectar Lifesciences Limited (NecLife), a leading integrated pharmaceutical company in India, offering specialized comprehensive range of oral and sterile cephalosporin and carbapenem APIs and FDFs, has said that its cephalasporin formulations manufacturing facility in Baddi, Himachal Pradesh, has received European cGMP (Current Good Manufacturing Practices) approval.
This approval will facilitate NecLife's entry into lucrative 27 European Union member states, EEU, South Africa and Middle East markets on account of mutual recognition.
After receiving EU cGMP for API facility in October 2011, NecLife has received the European cGMP compliance certification for its cephalosporin formulations facility in Baddi for injectables cephalsporins. This approval has been received following the successful inspection by the Hungarian Authority - National Institute for Quality and Organizational Development in Healthcare and Medicines, National Institute of Pharmacy (GYEMSZI-OGYI) in June 2011. Hungary being a member of European Union, the GYEMSZI-OGYI Certificate is accepted by all EU Health Authorities and by authorities of several other countries.
NecLife's Formulations facility, Unit-VI, has received this approval for cefotaxime sodium for injection, ceftriaxone sodium for injection and cefuroxime sodium for injection. Together these 3 products have a market potential in excess of US$ 1 Billion in the European countries.
According to a NecLife press release, till date, the company has filed 27 Drug Master Files (DMFs) and 6 Abbreviated New Drug Applications (ANDAs). Neclife has very ambitious plan of filing over 20 DMFs and multiple ANDAs/EU dossiers in US and EU markets in year 2012. These filings by NecLife will result in robust topline as well as bottomline for the company from year 2013 onwards in view of gestation period for regulatory approvals which take significant time in view of the current pendency."