The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
Spiro will be responsible for the overall strategy, implementation and growth of Lupin’s U.S. Generics business
The two-day event focused on the multi-faceted relationship of clinical research stakeholders and looked at bridging the academic and clinical research gap.
Expanded capacity in Nansha, China will support mid-scale manufacturing to ensure a smooth transition between early-phase and large-scale commercial production
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Evaluating Investigational Sitravatinib in combination with Nivolumab for patients with non-squamous non-small cell lung cancer
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
Diclofenac Sodium Topical Solution USP, 2% w/w has an estimated market size of US $512 million for twelve months ending Sep 2022 according to IQVIA
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