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Results For "reference-listed-drug"

185 News Found

Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP
News | January 22, 2025

Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP

According to IQVIATM sales data for the 12-month period ending November 2024, the Vitamin K1 Injectable Emulsion USP, 10 mg/mL market achieved annual sales of approximately $19.7 million


Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets
Drug Approval | January 21, 2025

Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets

The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets


Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules
Drug Approval | December 22, 2024

Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules

Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA


Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion
Drug Approval | December 17, 2024

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery


Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL
News | December 17, 2024

Glenmark USA launches Lacosamide Oral Solution, 10 mg/mL

According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million


Granules India FDA approval for ADHD treatment
Drug Approval | December 17, 2024

Granules India FDA approval for ADHD treatment


Gland Pharma receives approval for phytonadione injection emulsion
Drug Approval | December 12, 2024

Gland Pharma receives approval for phytonadione injection emulsion

This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.


Eugia Pharma receives USFDA approval for Pazopanib Tablets, 200 mg
News | December 06, 2024

Eugia Pharma receives USFDA approval for Pazopanib Tablets, 200 mg

The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA