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4

Oncology Products

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6

General Products

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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

Showing the advertising film of Arasto Chemical Industries

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.

01
Regulatory Affairs

 Plant Master File (Type I) and drug Master File (Type II) for all products.

02
Current Good Manufacturing Practice

Strict adherence to 847 comprehensive Standard Operating Procedures (SOPs) and Check Lists

03
Facilities

  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

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