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2469 News Found

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP
Drug Approval | July 23, 2024

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension


Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval
Drug Approval | July 22, 2024

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well


Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection
Drug Approval | July 22, 2024

Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)


Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD
Drug Approval | July 19, 2024

Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD

Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration


Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Drug Approval | July 14, 2024

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension


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


Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets
Drug Approval | July 10, 2024

Zydus receives final approval from USFDA for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan combination is used to treat chronic heart failure in adults


Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules
Drug Approval | July 10, 2024

Zydus receives tentative approval from USFDA for Diroximel Fumarate DR Capsules

Diroximel Fumarate Delayed-Release Capsules is indicated for the treatment of relapsing forms of multiple sclerosis


Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets
Drug Approval | July 10, 2024

Lupin receives tentative approval from USFDA for Empagliflozin, Linagliptin and Metformin Hydrochloride ER tablets

This product will be manufactured at Lupin’s Pithampur facility in India