Alembic Pharmaceuticals receives USFDA approval for Fingolimod Capsules ANDA
Approval for 0.5 mg capsules therapeutically equivalent to Novartis’ Gilenya; market size at US$ 145 million
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Alembic Pharmaceuticals
Alembic Pharmaceuticals secures USFDA approval for Dapagliflozin Tablets ANDA
Approval grants eligibility for 180-day shared generic drug exclusivity
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
Alembic Pharmaceuticals receives USFDA approval for Efinaconazole Topical Solution, 10%
Product is therapeutically equivalent to Jublia; company holds 234 USFDA ANDA approvals
Alembic Pharmaceuticals receives USFDA tentative approval for Bosutinib tablets
Alembic Pharmaceuticals announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for…
Alembic Pharmaceuticals gets USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%
Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration…
Alembic Pharmaceuticals receives USFDA approval for Loteprednol Etabonate and Tobramycin Ophthalmic…
Company secures final ANDA approval with eligibility for 180 days of CGT exclusivity
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 receives USFDA approval for Ticagrelor Tablets, 60 mg
Approval aligns Ticagrelor 60 mg with its reference drug Brilinta; estimated market size at US$ 236 million
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