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Results For "ANDA"

2205 News Found

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
Drug Approval | June 25, 2025

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA


Glenmark Pharmaceuticals launches TEVIMBRA in India
News | June 25, 2025

Glenmark Pharmaceuticals launches TEVIMBRA in India

TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines)


Cohance Lifesciences to sell CR Bio assets to Chromo Laboratories India for Rs. 16 Cr
News | June 23, 2025

Cohance Lifesciences to sell CR Bio assets to Chromo Laboratories India for Rs. 16 Cr

The CR Bio unit represents a non-core legacy asset with limited strategic alignment to our core CDMO operations


BASF opens new GMP Solution Center in US
News | June 23, 2025

BASF opens new GMP Solution Center in US

BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America


AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study
Diagnostic Center | June 21, 2025

AbbVie announces new data demonstrating Atogepant achieves superiority in Phase 3 study

TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month


Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma
Diagnostic Center | June 21, 2025

Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma

Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx


Sanner commences manufacturing critical injection-molded components in USA
Packaging | June 20, 2025

Sanner commences manufacturing critical injection-molded components in USA

The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space


UFlex introduces FSSAI compliant single-pellet solution for food packaging
Packaging | June 20, 2025

UFlex introduces FSSAI compliant single-pellet solution for food packaging

UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials


USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
Drug Approval | June 17, 2025

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations


Bristol Myers Squibb presents data across targeted protein degradation research at EHA 2025
News | June 16, 2025

Bristol Myers Squibb presents data across targeted protein degradation research at EHA 2025

Innovative agents highlight growth of targeted protein degradation platform and BMS' leadership in innovative cancer therapies