WANA (Mar 02) – Iran has successfully synthesized and industrially produced the active ingredient of topiramate, a key medication for epilepsy and migraine treatment. Until a few years ago, this pharmaceutical component was entirely imported, but local specialists have now made Iran self-sufficient in its production.

 

The project, titled “Synthesis of Topiramate Active Pharmaceutical Ingredient (API),” secured third place in the development category at the 38th Khwarizmi International Festival.

 

A Breakthrough in Local Drug Production of Iran

Farajollah Mohannazadeh, the lead researcher of the project, explained that topiramate is among the essential drugs for epilepsy. “A new generation of drugs was introduced with sugar-based structures instead of hydrocarbon ones. We aimed to develop such compounds locally. Starting in the lab, we succeeded step by step, advancing to semi-industrial and full-scale industrial production,” he stated.

 

Mohannazadeh further emphasized that, prior to this breakthrough, Iran only formulated the drug in tablet or capsule form using imported API. “For the first time, we have synthesized the active ingredient domestically, a substance that has been in use for several years,” he added.

 

Challenges in Raw Material Procurement

According to Mohannazadeh, producing the topiramate API requires 11 chemical components, two of which must be imported from China and India, while the rest are available in Iran. He urged the Food and Drug Administration (FDA) of Iran to prioritize support for domestic pharmaceutical companies by ensuring timely access to necessary raw materials.

 

“Our main issue is the delay in receiving foreign currency allocations, which is critical for a small, knowledge-based company like ours. Another challenge is pricing—nine of our required components are sourced domestically at free-market rates, but the final price is calculated based on subsidized exchange rates, making production financially difficult,” he noted.

 

He stressed the need for government support in streamlining regulatory approvals and financial assistance, arguing that small pharmaceutical firms should not be compared to large corporations. “We are not asking for subsidies; we just need timely access to our required funds and permits,” he concluded.