Drug Approval | March 27, 2023
Briefs: Morepen Laboratories and Zydus Lifesciences
The company is addressing these observations
The company is addressing these observations
This combination medicine is used to treat high blood pressure (hypertension).
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
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
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
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