Drug Approval | July 24, 2024
USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
The inspections concluded with no Form 483 observations or significant critical findings
The inspections concluded with no Form 483 observations or significant critical findings
Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape
Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration
The company will address these observations within the stipulated timeline
The approved ANDA is therapeutically equivalent to the reference listed drug product
Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025
Imfinzi also recommended for patients with mismatch repair deficient disease
Laurus Labs receives EIR from USFDA for API facilities
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
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