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Results For "GMP"

394 News Found

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'


Croda and AAHI partner to drive innovation in vaccine development
News | April 15, 2024

Croda and AAHI partner to drive innovation in vaccine development

The exclusive agreement between AAHI and Croda includes a collaborative effort in research and development


Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
Drug Approval | April 14, 2024

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.


USFDA completes inspection of Lupin's Dabhasa facility with no observations
Drug Approval | April 13, 2024

USFDA completes inspection of Lupin's Dabhasa facility with no observations

The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations


Asahi Kasei Bioprocess and Axolabs partner to accelerate oligonucleotide therapeutics development
News | April 11, 2024

Asahi Kasei Bioprocess and Axolabs partner to accelerate oligonucleotide therapeutics development

The partners will collaborate to build a cutting-edge oligonucleotide cGMP manufacturing facility


NATCO Pharma receives warning letter from USFDA for facility in Kothur, Telangana
Drug Approval | April 10, 2024

NATCO Pharma receives warning letter from USFDA for facility in Kothur, Telangana

The company will respond to the Warning Letter within the stipulated timelines


Wacker and Pantherna intensify collaboration in the development and production of mRNA biopharmaceuticals
Biotech | April 07, 2024

Wacker and Pantherna intensify collaboration in the development and production of mRNA biopharmaceuticals

Wacker Biotech is a CDMO for the GMP-compliant production of active ingredients for the pharmaceutical industry


Cipla Patalganga facility gets 6 USFDA observations
Drug Approval | April 07, 2024

Cipla Patalganga facility gets 6 USFDA observations

The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.


Aragen operationalizes first phase of its US$ 30 million Biologics manufacturing facility in India
News | March 30, 2024

Aragen operationalizes first phase of its US$ 30 million Biologics manufacturing facility in India

Executes the first project for developing and manufacturing a novel anticancer mAb


Briefs: Alkem Laboratories and Zydus Lifesciences
Drug Approval | March 28, 2024

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant