Arasto is the first private sector manufacturer of Active Pharmaceutical Ingredients (API) in Iran.  Founded in 1993, Arasto has been supplying APIs to domestic and international clients since 1996.  Business development, regulatory affairs, sales, marketing and other administrative and financial functions are conducted through our head office in Tehran. Manufacturing, QA/QC and material management departments are located in a 10,000 m2 facility in Kaveh Industrial Park, 90 km south of Tehran.   Research and Development, which are the distinguishing facets of Arasto, are conducted in our Tehran (Research) and Saveh (Development) laboratories. Arasto is owned by Avicenna Pharmaceuticals Inc. which  was accepted in Tehran Stock Exchange in 2018 and its shares are publicly traded under DAVEH (

• Reactors: 34 SS and GL from 20 to 5000 liters with total capacity of 102,000 liters including scale-up and pilot facilities
• Production Equipment: all equipment are totally closed system and include centrifuges, box Netsch filters, double cone dryer-blender-granulators (see our WIPO patent WO 2018/138569 Al), roller compactors and CoMills, etc.
• Utilities: boilers, RO water, vacuum pumps, steam ejectors, cooling towers, chillers and acid, base and disintegration scrubbers
• HVAC: single pass to Bag-in Bag-out (BiBo) HEPA filters to disintegration scrubbers
• Effluent Water: is under supervision of the Environmental Protection Agency. Treatment is carried out in Arasto’s water treatment plant and effluent water has COD and BOD below the levels allowed by of the Environmental Protection Agency
• QC and Microbiology Laboratories: state-of-the-art equipment such as HPLCs, GCs, UV, IR Atomic Absorption, polarimeter, etc. Access to high-end analytical instruments such as high resolution 1H and 13C NMR, Mass Spec, Single Crystal and Powder X-Ray through affiliation of our senior scientists as faculty members of major universities

Current Good Manufacturing Practice and Quality System
• Strict adherence to 847 comprehensive Standard Operating Procedures (SOPs) and Check Lists
• Stringent adherence to cGMP guidelines as set by the FDA and the ICH and regulations of 21 CFR Part 211 and PICs Part II, PE 00915 May 2021,
• Continuing in-house and off-site training of personnel on scientific, technical, cGMP and Chemistry, Manufacturing and Control–related (CMC) subjects and routine evaluation of personnel by testing of QA, QC, Material Management, Production and Engineering staff on the subject matter of training courses to ensure thorough understanding of the material covered and to improve the organization’s GMP culture
• Pharmaceutical Quality System: Chemistry, Manufacturing and Control (CMC) achieved by a very extensive Corrective Action Preventive Action (CAPA). Direct electronic deposition of data from working batch records and QC and microbilogy laboratories into CAPA and statistical analysis of all records by Full implementation of Quality System (QS) as per ICH Q10 result Preventive Actions followed by Corrective Actions

Regulatory affairs
• Drug Master Files Type I prepared according to M4(R4), M4Q(R1), M4S(R2), M4E(R2) ICH Q10 are available in CTD format for all products and their open portions are provided to our clients for submersion to their regulatory authorities
• Site Master File Type II in CTD format available for submission to regulatory authorities
• DMFs registered in Canada and EU

Material management
• Warehouses: raw material and intermediates and finished products including cold-chain
• Tank Farms: 360,000 liters of various solvents