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Results For "US-generics"

34 News Found

A.forall expands US generics portfolio
News | September 12, 2025

A.forall expands US generics portfolio

Four FDA-approved products strengthen portfolio and reaffirm commitment to global reach


Ajanta Pharma Q4 FY26 revenue surges 21% to Rs 1,422 Crore; PAT climbs 18%
News | May 06, 2026

Ajanta Pharma Q4 FY26 revenue surges 21% to Rs 1,422 Crore; PAT climbs 18%

FY26 revenue rises 17% to Rs 5,453 crore as US generics business jumps 49% and adjusted EBITDA margin improves to 26% for the quarter


Pharma stocks face Q4 reality check amid global headwinds
News | April 20, 2026

Pharma stocks face Q4 reality check amid global headwinds

Analysts expect modest revenue growth but pressure on profitability in the March quarter


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


Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry
Drug Approval | April 20, 2026

Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry

The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation


Lupin scores major US breakthrough with FDA nod for key diabetes drug
Drug Approval | April 10, 2026

Lupin scores major US breakthrough with FDA nod for key diabetes drug

The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets


Glenmark gets USFDA approval for generic Endometrin vaginal inserts
Drug Approval | April 09, 2026

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million


India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters
Drug Approval | April 09, 2026

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga


Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity
Drug Approval | April 07, 2026

Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity

Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.


Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Drug Approval | December 22, 2025

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia