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Nystatin

TRACKED

Polyene Antifungal

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
38
Intelligence briefs
3
Active regulatory actions
₹2,800 Cr
Est. India export value

INTELLIGENCE

Showing 3 of 3 briefs for Nystatin
REGULATORY INTELLIGENCE·Warning Letter

FDA Class II Recall: PAI Holdings' Subpotent Nystatin Oral Suspension Exposes Quality Control Gaps

PAI Holdings, LLC. dba Pharmaceutical Associates Inc initiated a Class II recall for subpotent Nystatin Oral Suspension. This event highlights critical quality control vulnerabilities, impacting procurement strategies and regulatory compliance for pharmaceutical buyers. Decision-makers must reassess supplier stability and diversify sourcing to mitigate future supply chain disruptions.

90-Day Activity
PSPriya Subramaniam· Intelligence Analyst
2020-08-19
REGULATORY INTELLIGENCE·Warning Letter

Crown Laboratories' Nystatin Cream Recall: Subpotency Exposes Stability Testing Gaps in Topical Antifungal Supply

Crown Laboratories initiated a Class II recall for 62,274 tubes of Nystatin Cream due to subpotency, impacting nationwide distribution. This event underscores critical vulnerabilities in stability testing and quality control for topical antifungal products, demanding immediate review of supplier qualification and internal quality assurance protocols by procurement and regulatory teams.

90-Day Activity
RMRohan Mehta· Senior Supply Chain Intelligence Analyst
2020-07-01
REGULATORY INTELLIGENCE·Recall

FDA Class II Recall: Pharmaceutical Associates' Subpotent Nystatin Oral Suspension Impacts US Supply

Pharmaceutical Associates, Inc. initiated a Class II recall of Nystatin Oral Suspension due to subpotency, affecting 6,288 bottles distributed nationwide. This event highlights critical quality control vulnerabilities in pharmaceutical manufacturing, demanding immediate attention from procurement and regulatory teams to ensure product efficacy and patient safety within the US market.

90-Day Activity
RMRohan Mehta· Senior Supply Chain Intelligence Analyst
2020-02-05