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Results For "compliance"

519 News Found

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
Drug Approval | August 16, 2023

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.


BioNTech appointing James Ryan as Chief Legal Officer
People | August 16, 2023

BioNTech appointing James Ryan as Chief Legal Officer

Ryan has nearly 20 years of global legal and IP expertise in the pharmaceutical industry


Lonza launches nebula absorbance reader for streamlined Endotoxin and Pyrogen testing
Digitisation | August 09, 2023

Lonza launches nebula absorbance reader for streamlined Endotoxin and Pyrogen testing

The instrument is fully integrated with Lonza’s latest WinKQCLSoftware to enable data integrity compliance, streamline training, and reduce validation burden


Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr
News | August 09, 2023

Hikal posts Q1 FY 24 consolidated PAT at Rs. 6.92 Cr

US FDA approval is in line with de-risking strategy for additional API site to service our global customer base


Brenntag partners with Qualifyze to enhance pharma audit offering
News | August 09, 2023

Brenntag partners with Qualifyze to enhance pharma audit offering

Qualifyze specializes in Good Practice audits (GxP) audits and covers a wide range of areas, including excipients, starting materials, packaging, sustainability


Mandaviya chairs 7th meeting of Central Institute Body of AIIMS and Chintan Shivir at NIHFW, Delhi
News | July 31, 2023

Mandaviya chairs 7th meeting of Central Institute Body of AIIMS and Chintan Shivir at NIHFW, Delhi

Chintan Shivir has provided a platform to hold discussions with higher officials and experts, which will help in evolving better practices of premier health institutions like AIIMS


USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
Drug Approval | July 24, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories