Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
The company has posted net profit of Rs.615.82 crores for the Financial Year ended March 31, 2024
With this, for all our USFDA facilities, EIRs are in place
The company will provide comprehensive response to USFDA for the observations
The company has received five final approvals
Prior to joining Alembic, he was working with Lupin Limited for more than 11 years
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
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