Drug Approval | November 21, 2022
Aurobindo Pharma receives 10 observations for Unit IX
The company had responded to the agency and carried out the required corrective actions.
The company had responded to the agency and carried out the required corrective actions.
The product is expected to be launched by Q4 FY23.
The approval further strengthens the Potassium Chloride franchise for the company.
Within the API segment, ~20% of the revenues came from the domestic market and ~80% from the exports market
The company registered with REACH Certificate for Ethyl Acetate with a tonnage band of more than 1000 TPA
Q2 FY23 business performance has been slow primarily due to lower volume offtake from pharmaceutical manufacturers
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Pantoprazole Sodium Sesquihydrate are proton pump inhibitors used in drugs to suppress the gastric acid secretion
Revenue is up 23% whereas Profit After Tax expands 29% for the company
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
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