Regulatory Information
Our commitment to regulatory compliance ensures the highest standards of safety, quality, and efficacy in all our pharmaceutical products.
Ethiopian FDA Compliance
All our products are registered and approved by the Ethiopian Food and Drug Authority (EFDA), ensuring they meet national safety and efficacy standards.
WHO Prequalification
We actively pursue WHO Prequalification for our essential medicines, enabling procurement by UN agencies and international organizations.
GMP Certification
Our manufacturing facilities are certified to Good Manufacturing Practice (GMP) standards, ensuring consistent quality in every batch.
Quality Management System
We maintain ISO 9001:2015 certified quality management systems across all operations, from raw material sourcing to final product distribution.
International Standards
Our products comply with international pharmacopoeial standards including USP, BP, and IP specifications.
Environmental Compliance
We adhere to environmental regulations and maintain sustainable manufacturing practices to minimize our ecological footprint.
Our Regulatory Commitment
At Addis Pharmaceutical Factory (APF), regulatory compliance is not just a requirement—it is fundamental to our mission of providing safe, effective, and affordable medicines to patients across Ethiopia and beyond.
We maintain comprehensive documentation and traceability systems that enable us to respond quickly to regulatory inquiries and ensure product recalls can be executed efficiently if ever necessary.
Our regulatory affairs team works closely with national and international health authorities to stay current with evolving requirements and to ensure our products meet or exceed all applicable standards.
Regulatory Inquiries
For regulatory documentation, product registration inquiries, or compliance questions, please contact our Regulatory Affairs department.
Contact Regulatory Affairs