Hetero Biopharma gets CDSCO panel nod to market, manufacture Tenecteplase
New Delhi: Pharma major Hetero Biopharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to manufacture and market Tenecteplase 30 mg, 40 mg, and 50 mg in Vial, indicated for "thrombolytic treatment of suspected myocardial infarction with persistent ST elevation."
However, this approval is conditional on Hetero Biopharma conducting a Phase IV clinical trial with 400 subjects.
This came after the drug maker Hetero Biopharma presented the proposal to manufacture and market the drug Tenecteplase (30 mg, 40 mg, and 50 mg) in vials for the indication "thrombolytic treatment of suspected myocardial infarction with persistent ST elevation" along with the results of the Phase III local clinical trial.
Tenecteplase is a modified form of recombinant human tissue plasminogen activator used in the emergency treatment of myocardial infarction and pulmonary emboli.
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