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
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
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.
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.
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
Pharmaceutical Quality System
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
