News | December 14, 2021
Lupin’s Goa plant receives EIR from US FDA
FDA changes inspection classification of the facility to Voluntary Action Indicated
FDA changes inspection classification of the facility to Voluntary Action Indicated
The company will manufacture a cancer immunotherapy product from 2022
Ichnos will receive an upfront payment of Euro 20.8 million as well as additional development and commercial milestone payments and tiered royalties based upon future global sales
GCC Biotech is manufacturing the kits on a public-private partnership (PPP) model
The investment will establish additional capacity across the entire global value chain from manufacturing of active pharmaceutical ingredients (API) to assembly and packaging, with the vast majority being invested in API capacity
The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
Under this scheme, the company will make a committed investment in plant and machinery, get incentives on incremental sales of pharmaceutical products
Approvals accorded under Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ drug intermediates and Active Pharmaceutical Ingredients (APIs
The setting up of these 8 plants will lead to a total committed investment of Rs. 260.40 crore
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Primary endpoints and secondary endpoints for which data are available were met in trial dominated by Covid-19 variants
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