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Alembic Pharmaceuticals has received final approval from the USFDA for its generic version of Paliperidone extended-release tablets, used to treat schizophrenia and schizoaffective disorder. The approval covers strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. The market size for these tablets is estimated at USD 48 million for the year ending June 2024.
The Economic Times

The Economic Times

Alembic Pharma gets USFDA nod for generic drug used to treat schizophrenia

Alembic Pharmaceuticals has received final approval from the USFDA for its generic version of Paliperidone extended-release tablets, used to treat schizophrenia and schizoaffective disorder. The approval covers strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. The market size for these tablets is estimated at USD 48 million for the year ending June 2024.

Fri, Sep 27, 2024

Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paliperidone extended-release tablets.
Business Standard

Business Standard

Alembic Pharma gets USFDA nod for Paliperidone extended-release Tablets

Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paliperidone extended-release tablets.

Fri, Sep 27, 2024

Alembic Pharmaceuticals has received approval from the USFDA to market Albendazole Tablets USP (200 mg), a generic drug for treating infections caused by worms. The tablets are equivalent to Impax Laboratories' Albenza and are used for conditions like parenchymal neurocysticercosis and cystic hydatid disease. Alembic Pharma shares rose 2.79% on Thursday.
The Economic Times

The Economic Times

Alembic Pharma gets USFDA nod for generic product

Alembic Pharmaceuticals has received approval from the USFDA to market Albendazole Tablets USP (200 mg), a generic drug for treating infections caused by worms. The tablets are equivalent to Impax Laboratories' Albenza and are used for conditions like parenchymal neurocysticercosis and cystic hydatid disease. Alembic Pharma shares rose 2.79% on Thursday.

Thu, Sep 5, 2024

Shares of Alembic Pharmaceuticals soared up to 4.13 per cent at Rs 1,135 per share on the BSE
Business Standard

Business Standard

Alembic Pharma shares rise after USFDA drug approval; check details here

Shares of Alembic Pharmaceuticals soared up to 4.13 per cent at Rs 1,135 per share on the BSE

Tue, Aug 27, 2024

Alembic Pharmaceuticals has been granted final approval from the USFDA for its generic Betamethasone Valerate Foam, intended to treat moderate-to-severe psoriasis of the scalp. This medication is equivalent to Luxiq Foam by Norvium Bioscience. Alembic’s shares ended 0.97% lower at Rs 1,089.90 on the BSE.
The Economic Times

The Economic Times

Alembic Pharma gets USFDA nod for generic drug

Alembic Pharmaceuticals has been granted final approval from the USFDA for its generic Betamethasone Valerate Foam, intended to treat moderate-to-severe psoriasis of the scalp. This medication is equivalent to Luxiq Foam by Norvium Bioscience. Alembic’s shares ended 0.97% lower at Rs 1,089.90 on the BSE.

Mon, Aug 26, 2024

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam.
Business Standard

Business Standard

Alembic Pharma gets USFDA nod for Betamethasone Valerate Foam

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam.

Sat, Aug 24, 2024

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam, 0.12%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Luxiq Foam, 0.12%, of Norvium Bioscience, LLC (Norvium).
Business Standard

Business Standard

Alembic Pharmaceuticals receives USFDA approval for Betamethasone Valerate Foam

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam, 0.12%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Luxiq Foam, 0.12%, of Norvium Bioscience, LLC (Norvium).

Sat, Aug 24, 2024

Alembic Pharmaceuticals announced approval from the USFDA to market Dabigatran Etexilate Capsules (110 mg) for deep vein thrombosis prophylaxis, equivalent to Pradaxa Capsules. The company now has 211 ANDA approvals. Shares closed 3.17% lower at Rs 1,076 on the BSE.
The Economic Times

The Economic Times

Alembic gets USFDA nod for generic medication

Alembic Pharmaceuticals announced approval from the USFDA to market Dabigatran Etexilate Capsules (110 mg) for deep vein thrombosis prophylaxis, equivalent to Pradaxa Capsules. The company now has 211 ANDA approvals. Shares closed 3.17% lower at Rs 1,076 on the BSE.

Tue, Aug 13, 2024

Most of the BSE Sectoral Indices were in the red, while TECk, IT and FMCG ended up being the outliers with around 2% gains. Dalal street celebrated the better-than-anticipated results of the Tech Big 4
Business Line

Business Line

Just Dial, Alembic Pharmaceuticals and Hatsun Agro Product: Three stocks that outperformed in the week ended July 19

Most of the BSE Sectoral Indices were in the red, while TECk, IT and FMCG ended up being the outliers with around 2% gains. Dalal street celebrated the better-than-anticipated results of the Tech Big 4

Sun, Jul 21, 2024

Alembic Pharmaceuticals Ltd has obtained final approval from the US FDA for its generic Bromfenac ophthalmic solution, used to treat postoperative inflammation and pain after cataract surgery. The approved product is equivalent to Prolensa Ophthalmic Solution, with an estimated market size of USD 168 million.
The Economic Times

The Economic Times

Alembic Pharma gets USFDA nod for generic Bromfenac ophthalmic solution

Alembic Pharmaceuticals Ltd has obtained final approval from the US FDA for its generic Bromfenac ophthalmic solution, used to treat postoperative inflammation and pain after cataract surgery. The approved product is equivalent to Prolensa Ophthalmic Solution, with an estimated market size of USD 168 million.

Wed, Jul 10, 2024

Alembic Pharmaceuticals Ltd received final approval from the US health regulator for generic Dabigatran Etexilate capsules 75 mg and 150 mg to reduce stroke and blood clots in adults with a specific medical condition.
The Economic Times

The Economic Times

Alembic Pharma gets USFDA nod for Dabigatran Etexilate capsules

Alembic Pharmaceuticals Ltd received final approval from the US health regulator for generic Dabigatran Etexilate capsules 75 mg and 150 mg to reduce stroke and blood clots in adults with a specific medical condition.

Tue, Jun 18, 2024

The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing.
The Economic Times

The Economic Times

Alembic Pharma gets USFDA nod for generic injection to treat hereditary angioedema

The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing.

Mon, Jun 17, 2024