By Fineline Cube 
The Zhejiang Provincial Medical Products Administration announced that Ningbo Dahongying Pharmaceutical Co., Ltd. has been found to have produced substandard Fluorouracil Injection and will face confiscation of the illicit drugs, seizure of illegal gains, and a substantial fine.
Regulatory Action
- Decision Date: 15 Oct 2025
- Penalties:
- Confiscation of all illegally produced Fluorouracil Injection batches.
- Confiscation of proceeds derived from the illicit production.
- Monetary fine (exact amount undisclosed).
- Procurement Impact:
- Dahongying Pharma’s qualification for the 10th‑round National Centralized Drug Procurement (VBP) program was revoked.
- Both Dahongying and the contract manufacturer Heilongjiang Fuhe Pharmaceutical Group Co., Ltd. were placed on the “non‑compliance list.”
- Eligibility to participate in national centralized drug procurement activities is suspended from 15 Oct 2025 to 14 Apr 2027.
Context
The Fluorouracil Injection, produced under contract by Fuhe Pharma, was one of six selected suppliers in the national procurement program. The remaining suppliers—Tianjin Tianyao Pharmaceutical, Sailong Pharmaceutical, ChoiteC Pharmacy, Southwest Pharmaceutical, and Lingnan Pharmacy—remain eligible as backup sources.
Company Response
Dahongying Pharma has acknowledged the decision and stated it is cooperating fully with the authorities. The company has initiated an internal audit and will work to rectify quality controls to prevent recurrence.
Market Implications
- Supply Chain: The suspension may tighten the supply of Fluorouracil Injection in China, potentially affecting oncology treatment schedules.
- Competitive Landscape: Backup suppliers could see increased demand and market share during the suspension period.
- Regulatory Signal: The action underscores the Chinese government’s commitment to enforcing drug quality standards amid large‑scale procurement initiatives.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech