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Results For "ANDA"

2125 News Found

Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows
News | June 02, 2025

Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows

Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows


Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets
News | May 06, 2025

Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets

Topiramate is indicated as a treatment of epilepsy and migraine


Strides acquires identified ANDAs from Nostrum Laboratories, USA
News | May 03, 2025

Strides acquires identified ANDAs from Nostrum Laboratories, USA

The portfolio consists of liquids and immediate release solid orals which are in the therapeutic segment to treat infections associated with UTIs


Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg
Drug Approval | April 14, 2025

Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg

The product will be launched in Q1FY26


Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%
Drug Approval | March 21, 2025

Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.


Senores Pharmaceuticals acquires 14 ANDAs from Dr. Reddy’s Laboratories
News | March 04, 2025

Senores Pharmaceuticals acquires 14 ANDAs from Dr. Reddy’s Laboratories

The basket acquired, comprises of 13 ANDAs, which are approved by the USFDA and 1 ANDA, which is pending approval from the USFDA


Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Drug Approval | February 27, 2025

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure


NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension
Drug Approval | February 10, 2025

NATCO, Lupin receive ANDA approval for Bosentan tablets for oral suspension

TFOS is indicated for the treatment of pulmonary arterial hypertension


India reaffirms commitment to global pharmaceutical standardization and regulatory convergence: Anupriya Patel
Policy | February 06, 2025

India reaffirms commitment to global pharmaceutical standardization and regulatory convergence: Anupriya Patel

International Meeting of World Pharmacopoeias serves as a vital platform to foster international collaboration in pharmacopoeial science and regulatory harmonization