Arasto Pharmaceutical Chemicals Inc.
• Arasto is the first private sector manufacturer of Active Pharmaceutical Ingredients (API) in Iran. Founded in 1991, Arasto has been supplying APIs to domestic and international clients since 1994. Research, Regulatory Affairs, Sales, Marketing and other administrative and financial functions are conducted through our head office in Tehran. Process Development, Manufacturing, QA/QC and material management Departments are located in Kaveh Industrial Park, 90 km south of Tehran.
• Arasto was granted a Science-Based Company status by the Office of the Vice President for Research and Development in 2016. This was based on Arasto’s record of excellence in Research and Development as demonstrated in numerous scientific publications and international patents.
• Arasto is the first manufacturer of Active Pharmaceutical Ingredients in Iran which has achieved de novo production of High Potency (HiPo) APIs in totally closed production systems. Occupational Exposure Limits (OELs) for our HiPo products have been measured by regulatory authorities in various steps of production and found to be considerably below the most stringent allowed limits (see Oncology Products). Closed system stainless steel and glass-lined productions equipment as well as isolators are designed in-house by our Engineering Department and fabricated by domestic manufacturers.
Research and Development
• The Most important facet of the overall operation.
• Comprised of a core of Ph.D. and M.Sc. chemists, Pharm.Ds with supporting technical staff including chemical, mechanical and electrical engineers
• Close scientific ties with a number of major academic institutions including faculty membership and Ph.D. committee membership of Arasto’s senior research staff in major university
• 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, Crystal and Powder X-Ray through major academic institutions
• Over 30 US and 600 international process and product patents (multiple filings) granted to our scientists http://www.freepatentsonline.com.
• Numerous scholarly publications in high impact scientific journals
• Development of novel synthetic procedures (non-infringing) patents based on client’s specifications
• Synthesis, characterization, determination of purity and assay and specification of secondary Reference Standards of our products (APIs and Related Compounds) according to ICH criteria ICH M$Q, 3.2.S.3.1;ICH Q7A 11.1 and ICH Q6A, 2.11, 3.2, 3.3)
Current Good Manufacturing Practice
• Strict adherence to over 1000 comprehensive Standard Operating Procedures (SOPs)
• Strict adherence to cGMP guidelines as set by the FDA and the ICH and regulation of 21 CFR Part 211
• Continuing in-house and off-site training of personnel on cGMP –related sunjects
• Quality Assurance Agreements with major Canadian pharmaceutical companies for API exports
• Arasto’s personnel attend various classes and workshops on GMP-related subjects within and outside the organization on a continuing basis. They are subsequently tested on the subject matter to ensure thorough understanding of the material covered and to improve the organization’s GMP culture
Quality Control and Quality Assurance
• State-of-the-art laboratories and equipment such as HPLCs, GCs, UV, IR Atomic Absorption, polarimeter, etc.
• Extensive records of CAPA based on statistical analysis of data
• Full implementation of Quality System (QS) as described in ICH Q10
• Continuing in-house and off-site training of personnel on quality-related issues
• 20000 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 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 centrifuges, closed-system centrifuges, Nutsche filter/dryers, isolators, double-cone dryers, vacuum dryers, mills, micronizers, nano-particle production equipment (ppt method), and blenders
• Contract manufacturing of oral and injectable anti-cancer APIs in a dedicated closed system facility.
• 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 Msater 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
• Secondary Reference Standards (APIs and Related Compound) of our products made available to clients free of charge
• DMFs registered in Europe and Canada