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Results For "approval"

2608 News Found

Nureca receives approval for new manufacturing facility
News | April 23, 2025

Nureca receives approval for new manufacturing facility

This unit will focus on the manufacturing of health and wellness equipment


Aptar commences clinical study to accelerate FDA approval of SmartTrack
News | April 19, 2025

Aptar commences clinical study to accelerate FDA approval of SmartTrack

SmartTrack aims to reduce the need for clinical studies in generic drug product approvals


Aarti Pharmalabs achieves SBTi approval of GHG emission reduction targets
Sustainability | April 17, 2025

Aarti Pharmalabs achieves SBTi approval of GHG emission reduction targets

Aarti Pharmalabs becomes 6th Indian Pharma/CDMO to earn SBTi approval for all 3 Scopes since 2022 demerger


Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg
Drug Approval | April 17, 2025

Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg

Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA


Rising Pharma gets final approval from USFDA for Mesalamine Suppositories 1000 mg
News | April 16, 2025

Rising Pharma gets final approval from USFDA for Mesalamine Suppositories 1000 mg

The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million


Zyuds Lifesciences receives USFDA approval for DMD treatment drug
Drug Approval | April 14, 2025

Zyuds Lifesciences receives USFDA approval for DMD treatment drug

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older


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


Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension
Drug Approval | April 12, 2025

Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension

Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas


OneSource secures GMP approval from Brazil for its flagship facility in Bengaluru
Drug Approval | April 11, 2025

OneSource secures GMP approval from Brazil for its flagship facility in Bengaluru

This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance


Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab
Drug Approval | April 11, 2025

Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab

Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis