Drug Approval | March 23, 2024
Briefs: Concord Biotech and Neuland Laboratories
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
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
Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease)
The initiative is a response to the rising incidents of heart attacks and cardiac arrests in the state
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