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Results For "Good-Manufacturing-Practice"

138 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'


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


Venus Remedies gets huge global acclaim with UNICEF GMP approval
News | March 12, 2024

Venus Remedies gets huge global acclaim with UNICEF GMP approval

Venus Remedies' manufacturing unit, located in Baddi, Himachal Pradesh, has been recommended for supplying cephalosporin dry powder to UNICEF


Briefs: Zydus, Advanced Enzyme Technologies, Link Pharma Chem and ANVISA
News | March 07, 2024

Briefs: Zydus, Advanced Enzyme Technologies, Link Pharma Chem and ANVISA

ANVISA issues CGMP to Concord Biotech’s Unit I


Concord Biotech receives GMP certificate from Kenya regulator
Drug Approval | February 26, 2024

Concord Biotech receives GMP certificate from Kenya regulator

The said Unit complies with the prescribed Good Manufacturing practices as per relevant WHO technical Report Series