Nectar Lifesciences (NecLife) has touched a significant milestone by receiving second European cGMP (Current Good Manufacturing Practices) approval for its Cephalosporin Finished Dosage Forms (FDF) manufacturing facility in Baddi, Himachal Pradesh. NecLife has received second European cGMP compliance certification for both Oral & Injectables Cephalsporins followed by the successful inspection by the Portugal Authority - National Authority of Medicines and Health Products, Infarmed in July 2013. The Infarmed Certificate is accepted by all EU Health Authorities and by authorities of several other countries.
NecLife's FDF facility, Unit-VI, has received this approval for all the Cephalosporin steriles and Non-sterile products which includes tablets, capsule, powder for oral suspension and powder for injections. This approval is a testimony to the high standards of quality and compliance practices put in place by the company. This approval will facilitate exports to the lucrative generic drug markets of Europe and this certification opens up lot of opportunities for Contract Manufacturing for NecLife for European customers. In addition to EU approval NLL is eagerly awaiting USFDA approval in writing anytime for its FDF & API facility inspections by USFDA between January 12 and January 24, 2014.
Nectar Lifesciences is a $200 million pharmaceutical organization. The company offers a range of Cephalosporin active pharmaceutical ingredients (APIs) and finished dosage forms.
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Wednesday, 11 June 2014
NecLife gets European cGMP approval for its Cephalosporin FDF Facility
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