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Results For "Good-Manufacturing-Practices"

75 News Found

USFDA inspects Gland Pharma’s Dundigal facility
Drug Approval | July 26, 2024

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations


Merck starts commercial production of first GMP-compliant manufacturing line for cell culture media in China
News | July 16, 2024

Merck starts commercial production of first GMP-compliant manufacturing line for cell culture media in China

€ 6.6 million investment at Nantong site expands production capabilities for cell culture media


Merck inks MoU with Afrigen Biologics for development of mRNA vaccine technology platform
News | July 05, 2024

Merck inks MoU with Afrigen Biologics for development of mRNA vaccine technology platform

Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization


Briefs: Dr. Reddy's Laboratories and Ami Organics
News | June 08, 2024

Briefs: Dr. Reddy's Laboratories and Ami Organics

Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility


Cipla receives 1 observation from USFDA for Kurkumbh facility
Drug Approval | May 10, 2024

Cipla receives 1 observation from USFDA for Kurkumbh facility

The company is committed to address this observation comprehensively within stipulated time


WACKER expands production capacity for biopharmaceuticals in San Diego
News | May 08, 2024

WACKER expands production capacity for biopharmaceuticals in San Diego

Wacker Biotech US, a wholly owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA


Caplin Point gets Colombia approval for Softgel Capsules
Drug Approval | May 07, 2024

Caplin Point gets Colombia approval for Softgel Capsules

The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms


Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Drug Approval | May 06, 2024

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II


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'