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Results For "ANDA"

2607 News Found

Dr. Lal PathLabs strengthens its genomics capabilities with Illumina's NovaSeq X Series
Biotech | June 26, 2025

Dr. Lal PathLabs strengthens its genomics capabilities with Illumina's NovaSeq X Series

The NovaSeq X system features Illumina's cutting-edge XLEAP-SBS chemistry, offering unmatched throughput, accuracy, and sustainability


Covestro launches localized production of medical-grade TPU in Asia Pacific
Medical Device | June 25, 2025

Covestro launches localized production of medical-grade TPU in Asia Pacific

Changhua site meets international regulatory standards for global medical applications


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
Clinical Trials | 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
Clinical Trials | 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