Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation
Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.
Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
Convergent action on AMR identified as an important area of intervention
Chinook Therapeutics is a clinical-stage biopharmaceutical company with two high-value, late-stage assets in development for IgA nephropathy (IgAN), a rare, progressive chronic kidney disease
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)
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