Alembic receives USFDA tentative approval for Larotrectinib Capsules ANDA
Company becomes sole first applicant for generic Larotrectinib Capsules with Paragraph IV certification
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Browsing Tag
ANDA approval
Lupin receives US FDA approval for generic colonoscopy preparation tablets
Approval grants Lupin 180-day generic drug exclusivity for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets in…
Lupin receives US FDA approval for Dapagliflozin tablets
Approval confirms bioequivalence to Farxiga for approved indications
Alembic Pharmaceuticals receives USFDA approval for Lamotrigine Orally Disintegrating tablets
Company secures final approval for ANDA across four strengths; cumulative USFDA ANDA approvals reach 235
Lupin receives US FDA approval for Brivaracetam Oral Solution 10 mg/mL
Company initiates US launch following ANDA approval for bioequivalent to Briviact
Granules Pharma receives USFDA tentative approval for amphetamine ER ODT ANDA
Approval covers multiple strengths for ADHD treatment, to be manufactured at US facility
Alembic Pharmaceuticals receives USFDA approval for Sumatriptan single-dose autoinjector
The product marks Alembic’s first drug–device combination to be approved in the United States
Alembic Pharmaceuticals secures USFDA approval for Triamcinolone Acetonide Injectable Suspension
Alembic Pharmaceuticals highlights expansion of its US portfolio with new injectable therapy approval
Alembic Pharma gets EIR for its API – I & API – II facility located at Panelav
USFDA had carried out the inspection between May 26 – May 31, 2025
Lupin gains USFDA approval for Loteprednol Etabonate Ophthalmic Gel
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity