CEP & EU ASMF-Supported
Veterinary APIs for Europe
Our Approach
Beyond Supply — Full EU Regulatory Support
At Bazayan, we offer a focused portfolio of veterinary APIs supported by CEP (Certificate of Suitability) and EU ASMF (Active Substance Master File).
Our approach goes beyond supply — we support our partners through the entire European regulatory pathway, ensuring faster approvals and seamless dossier integration.
Focused portfolio aligned with EU regulatory requirements and EDQM standards.
Deep understanding of MAH expectations, dossier integration, and EU GMP compliance.
From documentation to deficiency response assistance throughout the approval process.
Product Portfolio
Our CEP & EU ASMF API Portfolio
All listed APIs are supported with CEP or EU ASMF documentation, along with complete regulatory assistance for European market registration.
| # | Product Name | CEP | EU ASMF | CAS NUMBER | THERAPEUTIC CATEGORY |
|---|
Documentation Standards
What "Regulatory-Ready" Means
All listed APIs are supported with documentation aligned to European requirements.
CEP availability or submission status
EU ASMF (Open Part & Restricted Part)
Impurity profile and specifications
Stability data and manufacturing controls
Compliance with ICH and EU GMP expectations
Registration Support
How We Support EU Registration
We actively support our European partners throughout the registration process.
Our goal is to reduce regulatory friction and accelerate your time to market.
Why Bazayan
Focused portfolio with CEP & EU ASMF support
Understanding of European regulatory expectations
Experience working with EU-based partners
Reliable and consistent documentation practices
Long-term approach to regulatory compliance
Transparent & Ethical Sourcing
Commercial Advantage
Working with Bazayan means measurable value at every stage.
Faster dossier
preparation
Reduced regulatory
risk
Reliable API
sourcing
Better alignment with EU approval requirements
Looking for CEP or EU ASMF supported APIs?
- Request product-specific documentation
- Discuss regulatory requirements
- Explore long-term supply partnerships