Chemicals Inc
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Chemicals Inc.
Arasto Pharmaceutical
Chemicals Inc.
Chemicals Inc.
and
Quality Control
11
4
Oncology Products
13
6
General Products
6
2
Products Under Development
Arasto Pharmaceutical
Chemicals Inc.
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.
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)
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)
Current Good Manufacturing Practice
Strict adherence to 847 comprehensive Standard Operating Procedures (SOPs) and Check Lists
Pharmaceutical Quality System
Chemistry, Manufacturing and Control (CMC) achieved by a very extensive Corrective Action Preventive Action (CAPA) system
Quality Assurance and Quality Control
Statistical analysis of all records of manufacturing and direct electronic deposition of data from Working Batch Records and QC Laboratories documents in CAPA
Facilities
10,000 sq. meter complex includes Process Development (kilo lab), pilot and production, isolation, drying, milling and packaging (Class D), QC laboratories
Regulatory Affairs
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
Oncology Products
General Products
Products Under Development
Arasto Pharmaceutical Chemicals Inc.
Plant Master File (Type I) and drug Master File (Type II) for all products.
Strict adherence to 847 comprehensive Standard Operating Procedures (SOPs) and Check Lists
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
