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CHEMICAL & LIFE SCIENCES INTELLIGENCE
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Lanreotide Acetate

TRACKED

Somatostatin Analog

CAS127984-74-1HSN29372900
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
9
Manufacturers monitored
2
Intelligence briefs
1
Active regulatory actions
1
HSN code

INTELLIGENCE

Showing 2 of 2 briefs for Lanreotide Acetate
REGULATORY INTELLIGENCE·Warning Letter

Cipla USA Initiates Nationwide Recall of Lanreotide Injection Over Sterility Concerns at Contract Manufacturer Pharmathen

Cipla USA, Inc. has initiated a Class II nationwide recall of multiple lots of Lanreotide Injection, 120 mg/0.5 mL, due to a lack of sterility assurance. This critical regulatory action stems from FDA observations at its contract manufacturer, Pharmathen International, S.A., highlighting deficiencies in visual inspection procedures. This impacts supply and demands immediate attention from procurement and regulatory teams.

90-Day Activity
PSPriya Subramaniam· Intelligence Analyst
2026-04-15 Warning Letter
REGULATORY INTELLIGENCE·Recall

Cipla USA's Lanreotide Acetate Class II Recall: Particulate Matter Triggers Nationwide Supply Chain Review

Cipla USA, Inc. has initiated a Class II nationwide recall for 15,221 syringes of Lanreotide Acetate Injection due to particulate matter. This event, identified on January 2, 2026, signals critical quality control vulnerabilities impacting patient safety and supply chain integrity for this vital somatostatin analog. Procurement and regulatory teams must assess immediate supply risks and review internal quality assurance protocols.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2026-01-21