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Results For "classification"

83 News Found

Wanbury receives EIR from FDA for Patalganga facility
Drug Approval | August 23, 2024

Wanbury receives EIR from FDA for Patalganga facility

USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation


Lupin receives EIR from USFDA for its Dabhasa  facility
Drug Approval | July 13, 2024

Lupin receives EIR from USFDA for its Dabhasa facility

The facility is a part of Lupin Manufacturing Solutions


Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection
Drug Approval | July 09, 2024

Biostar Pharma gets FDA clearance of the IND application for a Phase 2 study of Utidelone Injection

Utidelone can penetrate BBB due to its unique physicochemical characteristics and insusceptibility to P-glycoprotein-mediated efflux


Jubilant Pharmova’s Roorkee unit gets VAI status
Drug Approval | April 18, 2024

Jubilant Pharmova’s Roorkee unit gets VAI status

FDA has concluded that this inspection is 'closed'


Briefs: Sun Pharma and Kimia Biosciences
News | April 14, 2024

Briefs: Sun Pharma and Kimia Biosciences

Sun Pharma's Dadra facility receives OAI status from US FDA


Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit
News | February 15, 2024

Aparna Group forays into pharma business; Receives USFDA clearance for manufacturing unit

The company is strongly committed to enhancing customer satisfaction and catering to the discerning needs of renowned pharmaceutical companies


Pfizer expects 2024 revenue between US$ 58.5 to US$ 61.5 billion
News | December 14, 2023

Pfizer expects 2024 revenue between US$ 58.5 to US$ 61.5 billion

Anticipates approx. US$8 billion in revenues for Comirnaty and Paxlovid


BrainSpec receives FDA clearance to begin using AI-backed solution for non-invasive brain chemistry measurement
Digitisation | November 28, 2023

BrainSpec receives FDA clearance to begin using AI-backed solution for non-invasive brain chemistry measurement

First-ever brain chemistry database will allow clinicians to quickly infer brain biomarker data to support the diagnostic process in conditions such as Alzheimer's Disease


LTTS, NVIDIA to unveil Gen AI and software defined architecture for medical devices
Digitisation | November 21, 2023

LTTS, NVIDIA to unveil Gen AI and software defined architecture for medical devices

This innovative solution comes as an answer to the industry-wide challenges of availability, cost, and dependencies linked to custom and proprietary hardware components


Lupin Mandideep plant gets USFDA green signal
Drug Approval | November 01, 2023

Lupin Mandideep plant gets USFDA green signal

The inspection of the facility conducted from August 7 to August 11, 2023