Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients
The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
The facility was inspected from May 7 to May 17, 2024
Second FDA approval for KRAZATI - reinforcing its potential across tumor types
This clearance is a foundational step in Roche's commitment to enable routine clinical diagnosis with its digital pathology solutions
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations
Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy
This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals
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