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Results For "Alembic-Pharma"

142 News Found

Alembic announces FDA final approval for Fingolimod capsules
Drug Approval | April 27, 2026

Alembic announces FDA final approval for Fingolimod capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)


Aniruddha Rajurkar appointed as CEO of Zenex Animal Health
People | April 10, 2026

Aniruddha Rajurkar appointed as CEO of Zenex Animal Health

In his new role, he is expected to further strengthen Zenex Animal Health’s market position and accelerate its next phase of growth.


India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters
Drug Approval | April 09, 2026

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga


Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets
Drug Approval | March 28, 2026

Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets

Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder


Alembic enters US branded market with first sales of Pivya UTI treatment
News | March 06, 2026

Alembic enters US branded market with first sales of Pivya UTI treatment

Pivya is Alembic’s first branded pharmaceutica product in the US and is being marketed through Alembic Therapeutics LLC


Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%
Drug Approval | February 25, 2026

Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%

Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.


Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%
Drug Approval | December 20, 2025

Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension


Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension
News | December 12, 2025

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb


Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg
Drug Approval | November 14, 2025

Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg

Dexlansoprazole delayed-release capsules are a proton pump inhibitor