Amantadine Extended-Release capsules had annual sales of US $2.7 million in the United States according to IQVIA data
Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency
The inspection of the facility was conducted from August 16-19, 2022.
Sildenafil for Oral Suspension had annual sales of USD 65 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).
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
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