Drug Approval | September 30, 2022
USFDA inspects Zydus Lifesciences Ahmedabad SEZ facility
The company will address the observations within a stipulated timeline working with the regulators
The company will address the observations within a stipulated timeline working with the regulators
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder
Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares
The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
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