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Nectar Lifesciences gets approval for Cephalosporin API’s manufacturing facility

The facility is already approved by various international regulatory agencies such as US-FDA, MCC – South Africa, PMDA – Japan, OGYI-Hungary and KFDA- South Korea.

May 14, 2015 4:38 IST | India Infoline News Service
Nectar Lifesciences Limited (NecLife), the fast-growing manufacturer of generic pharmaceutical active pharmaceutical ingredients (APIs) and formulation products has received ANVISA cGMP (“Current Good Manufacturing Practices”) approval for Brazil for its Cephalosporin APIs’ manufacturing facility in Dera Bassi, Punjab. The regulatory authority concluded that the facility, systems and practices comply with ANVISA cGMP requirements.
The facility is already approved by various international regulatory agencies such as US-FDA, MCC – South Africa, PMDA – Japan, OGYI-Hungary and KFDA- South Korea.
Brazil market for Cephalosporin’s’ is currently valued at USD 300 Mio. between injectable and oral molecules. NecLife has highest capacities globally of all the approved molecules in Cephalosporin. This approval opens up very valuable market for NecLife for API’s as well as formulations for which Unit-6 located in Baddi is already approved by the ANVISA authority.

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