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Results For "API"

2392 News Found

Nectar Lifesciences receives 7 observations from EDQM for API facility
News | March 12, 2025

Nectar Lifesciences receives 7 observations from EDQM for API facility

The European regulator will conduct a re-inspection of the facility to verify the compliance


Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility
Drug Approval | March 05, 2025

Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility

The company will provide the necessary response on these observations to USFDA within stipulated 15 days


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