Our Quality
Promise

We hold ourselves to the highest standards because your health depends on it. Every product we deliver is a reflection of our unwavering commitment to safety, efficacy, and reliability.

Manufacturing to the Highest Standards

Quality at the Core

At Amarox Pharma France, quality is not a department—it is a culture. Every step of our production process is governed by strict quality management systems aligned with international regulatory requirements.

Our parent company Hetero operates 38 state-of-the-art manufacturing facilities approved by the most stringent global regulatory authorities, ensuring every product that reaches patients meets the highest benchmarks of safety and efficacy.

Quality Standards We Live By

Our Framework

Good Manufacturing Practice (GMP)

All our products are manufactured in compliance with EU GMP standards, ensuring consistent quality at every stage of production from raw materials to finished product.

REGULATORY COMPLIANCE

Full compliance with French and European regulatory frameworks. Our products are approved by the ANSM (Agence Nationale de Sécurité du Médicament) and meet EMA standards.

BIOEQUIVALENCE TESTING

Rigorous bioequivalence studies confirm that our generic medicines deliver the same therapeutic effect as the original brand-name medicines they replace.

QUALITY CONTROL

Every batch undergoes extensive quality control testing including identity, purity, potency, and dissolution testing before release to the market.

SUPPLY CHAIN INTEGRITY

Our supply chain is monitored end-to-end to ensure the integrity of our medicines from manufacturing through to delivery to patients across France.

PHARMACOVIGILANCE

Ongoing monitoring of our products post-approval ensures we proactively identify and respond to any safety signals, protecting patients at all times.

Regulatory Approvals
& Certifications

Our manufacturing facilities are approved by the world's most stringent regulatory authorities.