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Results For "classification"

77 News Found

Granules’ packaging facility in US completes FDA inspection with zero observations
News | December 05, 2025

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US


Lupin Foundation bags CRISIL's Highest VO 1A rating for Excellence in Social Responsibility
News | November 29, 2025

Lupin Foundation bags CRISIL's Highest VO 1A rating for Excellence in Social Responsibility

This distinction is testament to LHWRF's dedication to excellence, transparency, and impact in the realm of social responsibility


Granules India’s facility secures FDA EIR with 'VAI’
Drug Approval | October 30, 2025

Granules India’s facility secures FDA EIR with 'VAI’

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025


Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1
Drug Approval | September 24, 2025

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated


FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US
Drug Approval | September 10, 2025

FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US

Sun Pharma's Halol plant gets OAI classification from US FDA inspection


Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
Drug Approval | July 17, 2025

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms


USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
Drug Approval | February 21, 2025

USFDA classifies Aurobindo Pharma Inc's warehouse as OAI

The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated


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