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Results For "API"

2531 News Found

Senores Pharmaceuticals begins operations at greenfield API facility
News | February 27, 2025

Senores Pharmaceuticals begins operations at greenfield API facility

This is Senores' second API manufacturing facility adding significantly to the existing API manufacturing capabilities.


USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
Drug Approval | February 27, 2025

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity


Orchid Pharma's Alathur API facility successfully completes USFDA inspection
Drug Approval | February 20, 2025

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics


Enhertu approved in US for breast cancer post more endocrine therapies
News | January 30, 2025

Enhertu approved in US for breast cancer post more endocrine therapies

Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year


Shilpa Pharma Lifesciences received CEP from EDQM for API, Teriflunomide
Drug Approval | January 24, 2025

Shilpa Pharma Lifesciences received CEP from EDQM for API, Teriflunomide

Teriflunomide is a novel disease-modifying agent that was approved for use in the treatment of multiple sclerosis


Sunshine Biopharma launches Olanzapine and Olanzapine ODT
News | January 22, 2025

Sunshine Biopharma launches Olanzapine and Olanzapine ODT

Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychotic disorders


GCPB revokes closure order of Aarti Pharmalabs’s Vapi plant
News | January 19, 2025

GCPB revokes closure order of Aarti Pharmalabs’s Vapi plant

The company has paid an Interim Environmental Damage Compensation of Rs. 3.40 lakh to GPCB


Heraeus acquires Umicore’s Platinum API business outside of South America
News | January 19, 2025

Heraeus acquires Umicore’s Platinum API business outside of South America

The company ensures a reliable and strong portfolio at competitive prices without compromising on excellent quality


Aragen secures $100 million investment from Quadria Capital
News | January 13, 2025

Aragen secures $100 million investment from Quadria Capital

Investment will fund expansion to meet rising demand for CRDMO services


Aarti Drugs receives EIR from USFDA for Tarapur API facility
Drug Approval | December 26, 2024

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP