Stelis Biopharma’s flagship facility receives EIR from USFDA
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
The company is excited about the strategic progress that the company has made so far and are confident of delivering better business outcomes
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
Dr. Reddy’s will manufacture the Active Pharmaceutical Ingredient and finished drug at its facilities approved by USFDA
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz®) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).
Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.
Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency
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