The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
The company will respond to these observations within the stipulated time period.
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
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.
Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022
Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.
Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep)
Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism
Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency
If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore
The company continue to develop this program for the WHO markets, thereby providing coverage and protection for more infants globally in time to come
MindRank expects to initiate a Phase I safety study in the first quarter of 2023.
Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of US $71 million for twelve months ending Sep 2022 according to IQVIA
Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH
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