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Results For "approvaL"

2683 News Found

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


Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg
News | April 10, 2025

Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg

Shilpa’s product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism)


Gland Pharma receives approval for Acetaminophen Injection
Drug Approval | April 04, 2025

Gland Pharma receives approval for Acetaminophen Injection

The company expects to launch this product through its marketing partner in the near future


Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial
Drug Approval | April 03, 2025

Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial

Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA


Morepen secures Loratadine approval for export to China
Drug Approval | April 01, 2025

Morepen secures Loratadine approval for export to China

This marks a significant milestone in Morepen’s strategic entry into one of the world’s largest pharmaceutical markets