By Fineline Cube 
China’s National Medical Products Administration (NMPA) announced enforcement actions against two India‑based active pharmaceutical ingredient (API) manufacturers following failed inspections, suspending import and domestic use of chlorpheniramine maleate from Supriya Lifescience Ltd. and rivastigmine hydrogen tartrate from Sun Pharmaceutical Industries Limited.
Inspection Outcomes & Enforcement Actions
| Company | Product | Inspection Type | Violations | NMPA Action |
|---|---|---|---|---|
| Supriya Lifescience Ltd. (India) | Chlorpheniramine maleate API | On‑site | Inadequate batch compliance, facility management, pest control | Import and domestic use suspended |
| Sun Pharmaceutical Industries Ltd. (India) | Rivastigmine hydrogen tartrate API | Remote | Insufficient OOS risk assessment, corrective actions, contamination control, pharmacopeia compliance | Import, sale, use, and import clearance suspended |
GMP Violations & Quality Failures
Supriya Lifescience – Chlorpheniramine Maleate
- Batch Compliance: Failed to meet GMP and registration requirements, indicating systemic manufacturing control deficiencies
- Facility Management: Inadequate infrastructure maintenance and operational oversight
- Pest Control: Deficiencies in pest management systems compromising API purity and quality
Sun Pharmaceutical – Rivastigmine Hydrogen Tartrate
- Quality Management: Insufficient out‑of‑specification (OOS) risk assessment and inadequate corrective and preventive actions (CAPA)
- Contamination Control: Failures in maintaining sterile processing environments
- Pharmacopeia Compliance: Non‑compliance with Chinese Pharmacopoeia standards for API purity and impurity profiles
Market Impact & Supply Chain Implications
- Regulatory Enforcement: Actions reflect NMPA’s heightened scrutiny of foreign API manufacturers amid China’s push for supply chain security and quality assurance
- Supply Disruption: Suspensions may impact domestic formulations dependent on these imported APIs, particularly generic antihistamines (chlorpheniramine) and Alzheimer’s treatments (rivastigmine)
- Indian Pharma Exposure: India supplies ~40% of China’s imported APIs; enforcement signals tighter GMP compliance demands
- Domestic Substitution: Expected to benefit Chinese API manufacturers as drug makers seek alternative qualified suppliers
- Precedent Setting: NMPA’s use of remote inspections for API oversight establishes new enforcement model for international suppliers
Forward‑Looking Statements
This brief contains forward‑looking statements regarding supply chain impacts and regulatory enforcement trends. Actual results may differ due to remediation timelines, alternative supplier sourcing, and evolving NMPA inspection policies.-Fineline Info & Tech