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Results For "ANDA-approval"

212 News Found

Alembic secures USFDA nod for Tretinoin Cream strengthening generics portfolio
Drug Approval | June 14, 2026

Alembic secures USFDA nod for Tretinoin Cream strengthening generics portfolio

The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream


Alembic Pharma receives USFDA tentative approval for generic Larotrectinib capsules
Drug Approval | June 11, 2026

Alembic Pharma receives USFDA tentative approval for generic Larotrectinib capsules

Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.


Aurobindo Pharma receives USFDA nod for generic Tofacitinib tablets
Drug Approval | June 05, 2026

Aurobindo Pharma receives USFDA nod for generic Tofacitinib tablets

Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval


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 and is indicated for the treatment of congenital or acquired hypothyroidism


Alembic Pharmaceuticals posts strong Q4 FY26 growth as net profit jumps 29%
News | May 18, 2026

Alembic Pharmaceuticals posts strong Q4 FY26 growth as net profit jumps 29%

US formulations grew 11% to Rs. 564 crore as Alembic enters US branded pharmaceuticals market with launch of Pivya


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


Senores Pharma reports 62% rise in FY26 total income to Rs. 664 crore
News | May 15, 2026

Senores Pharma reports 62% rise in FY26 total income to Rs. 664 crore

The company reported a 108% rise in profit after tax, driven by strong growth in regulated markets, branded generics, and U.S. expansion initiatives


Lupin Q4 FY26 PBT jumps 115% to Rs 19,280 million
News | May 08, 2026

Lupin Q4 FY26 PBT jumps 115% to Rs 19,280 million

U.S. business drives strong growth as Lupin reports 57% rise in Q4 U.S. sales and 43% increase in gross profit