Alembic receives USFDA final approval for Tretinoin Cream USP, 0.05%
ANDA approved for Tretinoin Cream USP, 0.05%, referencing Retin-A Cream, 0.05%
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Browsing Tag
Alembic Pharmaceuticals
Alembic receives USFDA tentative approval for Larotrectinib Capsules ANDA
Company becomes sole first applicant for generic Larotrectinib Capsules with Paragraph IV certification
Alembic Pharmaceuticals appoints Ramesh Juneja as Executive VP – Human Health for India business
Former Sun Pharma, Cipla and Reliance Retail executive to lead sales and marketing for Alembic Pharmaceuticals’ Human Health…
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
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