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Results For "USFDA-approval"

201 News Found

UFlex secures USFDA approval for recycled PE in food packaging
Packaging | March 12, 2025

UFlex secures USFDA approval for recycled PE in food packaging

Announces Rs. 317 crore investment in new recycling plant


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


Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia
Drug Approval | December 27, 2024

Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia

GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH


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


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


Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI
News | November 28, 2024

Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy


Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules
Drug Approval | November 20, 2024

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules

The product will be manufactured at Lupin’s Somerset facility in the US


Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
Drug Approval | October 02, 2024

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25


Lupin receives USFDA approval for Bumetanide Injection
Drug Approval | September 19, 2024

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.