Avicenna Pharmaceuticals Inc.
Avicenna is the first manufacturer of oral solid dosage form of drug products in Kaveh Industrial Park. Founded in 1999, Avicenna has been supplying its products to domestic and international clients since 2000. 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 Avicenna, are conducted in our Tehran (Research) and Saveh (Development) laboratories. Avicenna has two facilities, one for General products and one for High Potency (Hazardous) drug products. The second facility is the first factory for oral solid dosage form of drug products with totally closed production system in Iran. Avicenna was accepted in Tehran Stock Exchange in 2018 and its shares are publicly traded under DAVEH (TSETMC.com).
Manufacturing
- • Production Equipment: are located in two separate facilities, namely the general site and the high potency site. and include weighing compounding, oscillators, CoMills, double cone dryer-blender-granulators (see our WIPO patent WO 2018/138569 Al), roller compactors, auto fillers, tablet presses, coaters, capsuling, blistering, packaging and cartoning. All equipment in the high potency site are totally closed system which includes blender-bins, split butterfly valves, and elevators used for direct transfer of powders, tablets and capsules in the production chain.
• Utilities: boiler, RO water, purified water, vacuum pumps, screw-type compressor, cooling towers, chillers 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 Avicenna’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 1124 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 I, PE 00915 May 2021,
• Continuing in-house and off-site training of personnel on scientific, technical, cGMP and Chemistry, Manufacturing and Control (CMC)–related 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 microbiology laboratories into CAPA and statistical analysis of all records. 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 have been registered in regional counties and are being registered in the Russian Federation
Material management
• Warehouses: raw material and intermediates and finished products including cold-chain