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Results For "analytical-testing"

13 News Found

Center for Breakthrough Medicines launches analytical testing
Biotech | February 17, 2022

Center for Breakthrough Medicines launches analytical testing

More than 2,500 submissions are currently under review in the Food and Drug Administration's (FDA) cell and gene therapy pipeline


NAMSA expands US footprint with Labcorp medical device testing acquisition
News | January 12, 2026

NAMSA expands US footprint with Labcorp medical device testing acquisition

The deal brings Labcorp’s U.S. portfolio—including biocompatibility, microbiological, and analytical testing, as well as preclinical research—under NAMSA’s roof


Thermo Fisher opens two new centers in Hyderabad
Biotech | November 25, 2025

Thermo Fisher opens two new centers in Hyderabad

The new Bioprocess Design Center will serve as a cutting-edge scale-up hub for biologics and vaccine manufacturing


BASF opens new GMP Solution Center in US
News | June 23, 2025

BASF opens new GMP Solution Center in US

BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America


Briefs: Syngene International and Cipla
Drug Approval | February 23, 2025

Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’


Shilpa Medicare Bio Analytical unit gets
Drug Approval | June 27, 2024

Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA

This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies


USFDA inspects Shilpa Medicare’s bio-analytical laboratory in Hyderabad
Drug Approval | March 02, 2024

USFDA inspects Shilpa Medicare’s bio-analytical laboratory in Hyderabad

This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently


Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection
Drug Approval | May 23, 2023

Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection

This is the second US FDA GMP inspection of this facility within one year


Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division
Drug Approval | March 13, 2023

Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division

The company will be submitting the responses to US FDA observations within stipulated timeline


Shilpa Medicare Hyderabad facility receives US FDA clearance
News | September 23, 2022

Shilpa Medicare Hyderabad facility receives US FDA clearance

The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties