Drug Approval | April 22, 2024
Zydus launches Mirabegron ER Tablets in the US
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility
The inspection was concluded with few procedural observations
The WHO GMP approved vertically integrated ONCOLOGY unit of SAKAR has been selling products nationally since few quarters
ANVISA issues CGMP to Concord Biotech’s Unit I
The said Unit complies with the prescribed Good Manufacturing practices as per relevant WHO technical Report Series
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