News about "Alembic Pharma"

Alembic Pharma Gets USFDA Nod for Ophthalmic Suspension With CGT Manufacturing Advantage

The product has been granted Competitive Generic Therapy (CGT) designation, making Alembic eligible for 180 days of market exclusivity in the USA once the product is launched. This exclusivity period provides a significant commercial advantage by limiting competition during initial marketing.

Alembic Pharma | 12/12/2025 | By Darshana |  181

Alembic Pharma Appoints Former Syngene VP G Krishnan as New CFO

G Krishnan has taken over as the new Chief Financial Officer (CFO) of Alembic Pharmaceuticals, succeeding R. K. Baheti.

Alembic Pharma | 08/07/2025 | By Manvi |  697

Alembic Pharma Appoints Former Syngene VP G Krishnan as New CFO

G Krishnan has taken over as the new Chief Financial Officer (CFO) of Alembic Pharmaceuticals, succeeding R. K. Baheti.

Alembic Pharma | 08/07/2025 | By Manvi |  697

Alembic Pharma Gets Tentative Approval for Olopatadine Hydrochloride Ophthalmic Solution

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 percent (OTC) has an estimated market size of USD 22 million for twelve months.

Alembic Pharma | 07/12/2024 | By Aishwarya |  378

Alembic Pharma Gets FDA Approval for Lamotrigine Extended-Release Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK).

Alembic Pharma | 07/10/2024 | By Aishwarya |  683

Alembic Pharma Received FDA Approval for Fluphenazine Hydrochloride Tablets

Alembic Pharmaceuticals Ltd. has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.

Alembic Pharma | 25/07/2024 | By Aishwarya |  732

Alembic Pharma Gets USFDA Tentative Approval for Selexipag for Injection

Alembic Pharmaceuticals has secured tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Selexipag for Injection, 1,800 mcg/vial.

Alembic Pharma | 15/07/2024 | By Aishwarya |  783

Alembic Pharma Gets USFDA Approval for Bromfenac Ophthalmic Solution

Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (USFDA) for its generic Bromfenac Ophthalmic Solution.

Alembic Pharma | 11/07/2024 | By Aishwarya |  801

Alembic Pharma Gets Tentative Approval from FDA for Ivosidenib Tablets

Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivosidenib Tablets, 250 mg.

Alembic Pharma | 05/07/2024 | By Aishwarya |  560

Alembic Pharma Secures USFDA Tentative Approval for Bosutinib Tablets

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets, 100 mg and 500 mg.

Alembic Pharma | 02/07/2024 | By Aishwarya |  880