Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The approved ANDA is therapeutically equivalent to the reference listed drug product
Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea 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
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