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Archives: News

FDA Issues Warning Letter to Aspen Bioph

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs

Qvents
April 3, 2025

CDSCO Notifies New Online Export NOC Sys

Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs

Qvents Team
April 1, 2025

FDA Approves Sanofi’s New Hemophilia 

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment

Qvents Team
April 1, 2025

FDA Issues Repeat Warning Letter to Thai

The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP

Qvents
March 25, 2025

Strides Recall Several Lots of Topical G

Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US

Qvents
March 17, 2025

Glenmark Recalls Over 1.5 Million Bottle

Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication,

Qvents
March 3, 2025

USFDA Issues Warning Letter to Global Ca

Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in

Qvents
February 17, 2025

FDA Issues Warning letter to Chinese API

FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing

Qvents
February 12, 2025

Timeline for Revised Schedule M Implemen

Health Ministry in India has extended the timeline for implementation of the revised Schedule M

Qvents
January 30, 2025

CDSCO Drug Alert: Assay, Dissolution Fai

In December 2024, the Indian drug regulator, CDSCO, flagged 51 drugs as Not of Standard

Qvents
January 27, 2025

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Latest Posts

Shiva Analytical Warning Letter: Data Integrity, Deficient OOS Handling Cited
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Qvents Apps and Tools For QMS and GMP Processes
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Natco Pharma USFDA 483 Flags Deficiencies in Aseptic Areas, Validation
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Loss of Potency: Accord / Intas Recall Hypothyroidism / Thyroxine Drug
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