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Results For "reference-listed-drug"

232 News Found

Glenmark Pharma introduces Vancomycin Injection in U.S. market
News | May 18, 2026

Glenmark Pharma introduces Vancomycin Injection in U.S. market

The product is bioequivalent and therapeutically equivalent to the reference listed drug by Fresenius Kabi USA, LLC.


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


Alembic announces FDA final approval for Fingolimod capsules
Drug Approval | April 27, 2026

Alembic announces FDA final approval for Fingolimod capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)


Marksans Pharma receives USFDA approval for Benzonatate capsules
Drug Approval | April 02, 2026

Marksans Pharma receives USFDA approval for Benzonatate capsules

Benzonatate is a non-narcotic antitussive that numbs stretch receptors in the respiratory tract


Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets
Drug Approval | March 28, 2026

Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets

Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder


Glenmark Therapeutics USA launches fluticasone propionate nasal spray
News | March 20, 2026

Glenmark Therapeutics USA launches fluticasone propionate nasal spray

The Flonase Allergy Relief Nasal Spray, 50 mcg per spray market achieved annual sales of approximately $384.7 million