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Results For "USFDA-approval"

194 News Found

Zydus Cadila receives tentative USFDA approval for Brivaracetam
News | June 15, 2021

Zydus Cadila receives tentative USFDA approval for Brivaracetam

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad


NATCO Pharma receives USFDA approval for Lenalidomide capsules
Policy | May 24, 2021

NATCO Pharma receives USFDA approval for Lenalidomide capsules

NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.


Alembic gets USFDA approval for Lurasidone Hydrochloride tablets
News | May 15, 2021

Alembic gets USFDA approval for Lurasidone Hydrochloride tablets

Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder


Alembic announces USFDA approval for two drugs
News | May 06, 2021

Alembic announces USFDA approval for two drugs

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA


Caplin Steriles gets USFDA approval
News | April 23, 2021

Caplin Steriles gets USFDA approval

The injection comes in multiple formats


Zydus Cadila announces USFDA approval for Ibrutinib capsules
News | April 08, 2021

Zydus Cadila announces USFDA approval for Ibrutinib capsules

Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.


Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets
News | February 25, 2021

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets

ranules now has a total of 38 ANDA approvals from US FDA.


NIFTY Pharma remains resilient amid mixed market sentiment
News | May 05, 2026

NIFTY Pharma remains resilient amid mixed market sentiment

Pharma and healthcare stocks stay in focus as investors track earnings, USFDA approvals, hospital growth, and global market pressures


Caplin Steriles gets FDA approval for desmopressin
Drug Approval | March 02, 2026

Caplin Steriles gets FDA approval for desmopressin

Desmopressin Acetate Injection is primarily used to treat central diabetes insipidus, haemophilia A, and von Willebrand disease


Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease
Drug Approval | February 07, 2026

Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease

This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease