According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
For the last ten financial years, the company has posted healthy performance with its revenue from operations growing at 15% CAGR and net profit at 23% CAGR
The certification will open new avenues for our flagship brand “Dr Trust”, enabling them to export these devices to many more countries
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US
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
Subscribe To Our Newsletter & Stay Updated
