News about "Alembic Pharmaceuticals"

Alembic Pharmaceuticals Announces US FDA Final Approval for Tretinoin Cream

Alembic Pharmaceuticals has received US Food and Drug Administration (FDA) final approval for Tretinoin Cream USP, 0.05 percent, a generic version of Bausch Health’s Retin-A Cream.

Alembic Pharmaceuticals | 12/06/2026 | By News Bureau

Alembic Pharma Receives USFDA Approval for Haloperidol Tablets

Alembic Pharmaceuticals has received final US FDA approval for Haloperidol Tablets USP in multiple strengths. The medication is indicated for the management of psychotic disorders and the treatment of tics and vocal utterances associated with Tourette’s Disorder in both children and adults, expanding Alembic’s US CNS product portfolio.

Alembic Pharmaceuticals | 05/06/2026 | By News Bureau

Alembic Pharma Names Ramesh Juneja as EVP, Human Health

Alembic Pharmaceuticals has appointed Ramesh Juneja as Executive Vice President–Human Health for its India business. Bringing leadership experience from Sun Pharma, Cipla and Reliance Retail, Juneja will spearhead sales and marketing initiatives to drive growth in Alembic’s domestic pharmaceutical business.

Alembic Pharmaceuticals | 02/06/2026 | By News Bureau

Alembic Pharmaceuticals Receives US FDA Final Approval for Levothyroxine Sodium Tablets

Alembic Pharmaceuticals receives final US Food and Drug Administration (FDA) approval for multiple strengths of Levothyroxine Sodium Tablets USP, expanding its portfolio of generic therapies for thyroid disorder management.

Alembic Pharmaceuticals | 22/05/2026 | By News Bureau

Alembic Pharmaceuticals Gets US FDA Tentative Nod for Darolutamide Tablets

Alembic Pharmaceuticals receives tentative US Food and Drug Administration (FDA) approval for Darolutamide Tablets 300 mg, a generic equivalent to Nubeqa by Bayer.

Alembic Pharmaceuticals | 15/05/2026 | By News Bureau

Alembic Pharmaceuticals Gains USFDA Approval for Dapagliflozin Tablets ANDA

Alembic Pharmaceuticals receives USFDA approval for Dapagliflozin Tablets ANDA, gaining eligibility for 180-day shared generic drug exclusivity and strengthening its diabetes portfolio.

Alembic Pharmaceuticals | 07/04/2026 | By News Bureau |  138

Alembic Pharmaceuticals Secures US FDA Approval for Paroxetine ER Tablets

U.S. Food and Drug Administration grants final approval to Alembic’s sANDA for paroxetine extended-release tablets, used in treating depression and anxiety-related disorders.

Alembic Pharmaceuticals | 30/03/2026 | By News Bureau |  120

Alembic Pharmaceuticals Records First US Prescription Sale of Pivya, Marking Entry into Branded Drug Market

Alembic Pharmaceuticals reports first prescription sale of Pivya in the US, marking its entry into the branded pharmaceutical segment with a first-line oral antibiotic for uncomplicated urinary tract infections in women.

Alembic Pharmaceuticals | 07/03/2026 | By News Bureau |  128

Alembic Pharmaceuticals Wins US FDA Approval for Generic Efinaconazole Topical Solution

Alembic Pharmaceuticals receives US FDA approval for generic efinaconazole topical solution, targeting a US market estimated at USD 500 million.

Alembic Pharmaceuticals | 24/02/2026 | By News Bureau |  284

Alembic Pharma Secures US FDA Tentative Approval for Bosutinib Tablets

The USFDA’s tentative approval confirms that Alembic Pharmaceuticals’ Bosutinib Tablets, 400 mg, meet therapeutic equivalence requirements with the Reference Listed Drug (RLD) Bosulif, marking an important step towards potential market entry.

Alembic Pharmaceuticals | 12/01/2026 | By News Bureau |  203