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1444 News Found

Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets
Drug Approval | May 22, 2026

Alembic Pharma receives USFDA nod for generic Levothyroxine sodium tablets

approved product is therapeutically equivalent to Synthroid of AbbVie Inc. and is indicated for the treatment of congenital or acquired hypothyroidism,


Caplin Steriles receives USFDA approval for generic foscarnet sodium injection
Drug Approval | May 18, 2026

Caplin Steriles receives USFDA approval for generic foscarnet sodium injection

Antiviral injection addressing CMV and HSV infections had US market sales of nearly $15 million in the last 12 months


Lupin receives USFDA nod for Famotidine injection
Drug Approval | May 15, 2026

Lupin receives USFDA nod for Famotidine injection

Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market


Alembic Pharma receives USFDA tentative approval for Darolutamide tablets
Drug Approval | May 15, 2026

Alembic Pharma receives USFDA tentative approval for Darolutamide tablets

Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States


Caplin Steriles receives USFDA approval for Calcium Gluconate Injection
Drug Approval | May 06, 2026

Caplin Steriles receives USFDA approval for Calcium Gluconate Injection

Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million


Lupin receives USFDA approval for generic Ravicti oral liquid
Drug Approval | May 05, 2026

Lupin receives USFDA approval for generic Ravicti oral liquid

Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders


Cipla wins USFDA nod for first generic of Ventolin HFA strengthening respiratory push
Drug Approval | April 27, 2026

Cipla wins USFDA nod for first generic of Ventolin HFA strengthening respiratory push

The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA


Cipla’s generic Ventolin HFA secures USFDA approval
Drug Approval | April 23, 2026

Cipla’s generic Ventolin HFA secures USFDA approval

Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market


Supriya Lifescience receives USFDA EIR with VAI classification for Maharashtra API facility
News | April 22, 2026

Supriya Lifescience receives USFDA EIR with VAI classification for Maharashtra API facility

Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States


Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid
Drug Approval | April 20, 2026

Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid

The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics