Romanian Excellence in Continuity and Performance
Today, we stand as Romania’s largest producer of generic medicines, driven by a firm commitment to sustainable development goals through investment in research, development, and innovation. By expanding our production capacities and fostering long-term partnerships across the entire value chain, we contribute to improving health and quality of life, while creating long-term value for society, customers, and shareholders.
Through these achievements and our unwavering dedication to quality and innovation, we remain a key pillar of Romania’s healthcare system and a trusted provider for both patients and medical professionals.
Seven Decades of Excellence
With a legacy spanning over seven decades, Antibiotice Iași has established itself as one of Romania’s leading producers of generic medicines. Our development has always been guided by our mission: to manufacture high-quality, effective medicines, ensuring patient access to essential treatments and enhancing medical care in hospitals. Our global presence is expanding, with products exported across all continents, making valuable medicines more accessible to patients in Romania and worldwide.
What Do We Produce?
Our diverse portfolio includes over 160 products across several key categories:
- Human-use medicines
- Dermocosmetics, dietary supplements, and medical devices
- Biotechnology-based active substances derived from Streptomyces noursei (compacted, micronized, and standard Nystatin for pharmaceutical use)
- Veterinary products
- Biocidal products for surface and hand disinfection
All medicines are manufactured across eight GMP-certified production lines, verified by the Romanian National Agency for Medicines and Medical Devices (ANMDMR). We operate a state-of-the-art Research Center and an authorized Clinical Studies Center, ensuring compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) standards for Phase I and bioequivalence studies.
Most Antibiotice medicines require a prescription (Rx), but our portfolio also includes over-the-counter (OTC) drugs, dietary supplements, medical devices, and cosmetics, designed to prevent illnesses and improve quality of life. Our generic medicines primarily address infectious diseases, but we also develop treatments for cardiovascular, dermatological, digestive, and central nervous system conditions.
Domestic and International Markets
In Romania, we remain the leading producer of anti-infective generic medicines, supplying hospitals and pharmacies with affordable, high-quality treatments. Our hospital-targeted anti-infective medicines generate significant savings for the national healthcare system.
Globally, Antibiotice products are trusted in over 30 countries, used by healthcare professionals in highly regulated markets such as the USA, the UK, Denmark, Norway, the Netherlands, Spain, Poland, Vietnam, and Serbia. Through our Territorial Expansion Plan, we are actively growing our presence in Germany, Italy, the Czech Republic, the UAE, Australia, and other promising markets where we are in negotiations with partners.
Our Nystatin, produced through a unique biosynthesis process in Romania, has been recognized since 2017 as the global reference standard by the United States Pharmacopeia (USP). Manufactured in Iași, this product is exported to 55 countries, making Antibiotice the world leader in this segment.
Commitment to the Highest Quality Standards
Our continuous growth and global expansion have been made possible through strategic investments and adherence to internationally recognized quality standards:
- Good Manufacturing Practice (EU-GMP)
- Certificate of Suitability to the European Pharmacopoeia (CEP/COS)
- U.S. Food and Drug Administration (FDA) Authorization
- Good Clinical Practice (GCP)
- Good Laboratory Practice (GLP)
Beyond global recognition, we remain deeply committed to our mission: improving health and enhancing lives in Romania and around the world. Antibiotice Iași does not market products or services that have been banned or withdrawn in any region or country.
