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Results For "Good-Manufacturing-Practice"

131 News Found

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'


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


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.


Briefs: Concord Biotech and Neuland Laboratories
Drug Approval | March 23, 2024

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483


Carbogen Amcis (Shanghai) completed ANVISA Audit
Drug Approval | March 19, 2024

Carbogen Amcis (Shanghai) completed ANVISA Audit

A five-day inspection was concluded successfully with no critical and no major observations raised


Grace expands CDMO capacity by 25% of South Haven facility in Michigan
News | March 19, 2024

Grace expands CDMO capacity by 25% of South Haven facility in Michigan

Additional capacity broadens Grace’s fine chemical capabilities for API production