Oct. 24, 2025 - Pharma API

Successful CEP Approval for Procaine Hydrochloride

We are pleased to share that on 2 September 2025, the European Directorate for the Quality of Medicines & HealthCare (EDQM) granted the Certificate of Suitability (CEP 2024-577 – Rev 00) for Procaine Hydrochloride (manufacturer: Chongqing Southwest No. 2 Pharmaceutical Factory). 

Welding acted as the authorized European representative and coordinated the submission on behalf of the manufacturer. 
The European Drug Master File (EU-DMF) for the active pharmaceutical ingredient Procaine Hydrochloride was completed and submitted to EDQM, a standard procedural step required before the issuance of a CEP. 

The well-structured documentation, including the EU-DMF, supported the review process and allowed the CEP to be issued within 8 months.  
This represents an important step for stakeholders who have been awaiting the opportunity to simplify regulatory procedures through a centralized CEP reference. 

Welding is the exclusive representative for the CEP-certified material within Europe. 

For pharmaceutical professionals: If you are interested in further details, please feel free to reach out directly.