CinnaGen secures EU approval for osteoporosis drug in historic first for Iranian pharma
CinnaGen has become the first Iranian pharmaceutical company to receive approval from the European Commission for one of its medicines.
According to a report by PHANA, Iranian health and medicine news website, during the February 2026 meeting of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the committee issued positive opinions for the marketing authorization of 12 new medicines in the European Union.
Among them was CinnaGen’s teriparatide product, marketed under the brand name Zandoriah, indicated for the treatment of osteoporosis.
The positive opinion followed a comprehensive scientific and regulatory evaluation process conducted under the European Union’s biosimilar guidelines.
The process included rigorous assessment of quality documentation, advanced analytical data, comparative studies, preclinical and clinical data, quality assurance systems, and full compliance with the European Union’s strict Good Manufacturing Practice (GMP) requirements.
The EMA’s positive opinion also demonstrates that CinnaGen’s development, manufacturing, and quality control infrastructure fully complies with European Union regulatory standards.
These standards represent the highest level of international requirements in areas such as data transparency, product traceability, manufacturing controls, and post-marketing surveillance.
💊 In a groundbreaking achievement for Iran's pharmaceutical industry, SinaGen received European Commission approval for its osteoporosis drug Zandoriah (teriparatide). The green light allows the company to market the drug across all 27 EU member states and three EEA countries. pic.twitter.com/q7azNRli3e
— Press TV 🔻 (@PressTV) June 2, 2026
Ultimately, the European Commission endorsed the CHMP’s recommendation and granted final authorization for Zandoriah to enter the European Union market.
With this approval, CinnaGen is now authorized to market Zandoriah across all 27 European Union member states — including Germany, France, Italy, Spain, the Netherlands, and Belgium — as well as in the three European Economic Area (EEA) countries of Iceland, Liechtenstein, and Norway.
According to the report, it marks a historic development that can be regarded as a major turning point in the history of Iran’s pharmaceutical industry.
Zandoriah is a biosimilar version of Forsteo, the osteoporosis medicine developed by the American pharmaceutical company Eli Lilly.
Like the reference product, it is indicated for the treatment of osteoporosis in postmenopausal women, men at increased risk of fractures, and men and women at increased risk of fractures associated with long-term glucocorticoid (steroid) therapy.
CinnaGen has been marketing teriparatide in Iran for more than a decade under the brand name Cinopar.
Notably, in 2018, CinnaGen had already become the first Iranian pharmaceutical company to obtain European Union GMP certification — another historic achievement that laid the foundation for today’s success in securing European Commission approval for Zandoriah.
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