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Results For "ANDA-approval"

201 News Found

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product


Briefs: Alembic Pharmaceuticals  and Relonchem
Drug Approval | July 05, 2024

Briefs: Alembic Pharmaceuticals and Relonchem

Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025


Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg
Drug Approval | June 29, 2024

Alembic Pharmaceuticals announces USFDA final approval for Doxycycline Capsules, 40 mg

Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients


Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules
Drug Approval | June 19, 2024

Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients


Alembic announces USFDA final approval for Icatibant injection
Drug Approval | June 17, 2024

Alembic announces USFDA final approval for Icatibant injection

This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals


Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets
Drug Approval | May 30, 2024

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death


Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25
Drug Approval | May 10, 2024

Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25

Receives 3 final and 2 tentative product approvals thus far in Q1FY25


Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray
Drug Approval | March 20, 2024

Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray

The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024


Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg
Drug Approval | March 02, 2024

Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg

The product will be launched in March 2024