Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
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
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings
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
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