Arasto Pharmaceutical Chemicals Inc.
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 Kaveh Industrial Park, 90 km south of Tehran. Arasto was granted Science-Based Company status by the Office of the Vice President for Research and Development in 2016. This was based on its record of excellence in Research and Development as demonstrated in numerous scientific publications and international patents of the Azhand Group (see http://www.freepatentsonline.com, KhashayarKarimian, http://ibb.ut.ac.ir/karimian) and included de novo production of High Potency (HiPo) APIs in totally closed production systems which were designed by Azhand engineering and technical staff and manufactured by various domestic fabricators. All production equipment have been validated for pressure differentials, ammonia leak, dispersed oil particulate (DOP), and naproxen surrogate tests (ISO 14644-1:2015, EU GMP Annex 1, 21 CFR Part 11). Occupational exposure limits (OELs) in various steps of production have been measured and certified by regulatory authorities and found to be considerably below the allowed limits, allowing Arasto Category V HiPo oral and injectable API production.
Research and Development
• This is the distinguishing facet of Arasto and is carried out by Andisheh Inc. as the group’s CRO. (see Andishehct.com)
• In-house 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 major academic institutions.
• 89 international product and process patents (34 US) and over 115 scholarly publications in high impact scientific journals (see http://www.freepatentsonline.com, KhashayarKarimian, http://ibb.ut.ac.ir/ karimian)
• Development of non-infringing process patents based on client’s specifications.
Pharmaceutical Quality System, Quality Assurance and Quality Control
Chemistry, Manufacturing and Control (CMC) achieved by a very extensive Corrective Action Preventive Action (CAPA) system
Statistical analysis of all records of manufacturing and direct electronic deposition of data from Working Batch Records and QC Laboratories documents in CAPA
Full implementation of Quality System (QS) as described in ICH Q10
Continuing in-house and off-site training of personnel on CMC-related issues
Current Good Manufacturing Practice
• Strict adherence to 847 comprehensive Standard Operating Procedures (SOPs) and Check Lists
• Strict adherence to cGMP guidelines as set by the FDA and the ICH and regulation of 21 CFR Part 211 and PICs
• Continuing in-house and off-site training of personnel on scientific, technical, cGMP and CMC–related subjects
• 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
• Quality Assurance Agreements with major Canadian pharmaceutical companies for API exports
• 10,000 sq. meter complex includes Process Development (kilo lab), pilot and production, isolation, drying, milling and packaging (Class D), QC laboratories, Closed System Equipment for the production of high potency (HiPo) APIs (including Category V oncology APIs), utilities and services, water purification (RO), water treatment units, tank farms and raw material and API warehouses
• Total glass-lined and stainless steel reactor capacity of 102000 liters (15 to 5000 liters) with support equipment such as closed-system centrifuges, closed Nutsche filter/dryers, isolators, double-cone dryers, vacuum dryers, mills, micronizers, nanoparticle production equipment (ppt method) and blenders.
• Bag-in and Bag-out (BiBo) and scrubber treatment of all single-pass HVAC systems
• Extensive water treatment facility
• Consistently lower levels of BOD and COD of effluent water than those required by the Environmental Protection Organization.
• Plant Master File (Type I) and drug Master File (Type II) for all products.
• Submission of the open portion of DMFs in eCTD format to clients for Regulatory Affairs
• DMF submission in eCTD format to international regulatory authority for product registration
• Iran FDA-certified Secondary Reference Standards (APIs and Related Compound) of our products made available to clients
• DMFs registered in Europe and Canada