Avicenna Laboratories Inc.

  • Avicenna Laboratories Inc. is a manufacturer of solid dosage form of drug products. Founded in 2003, the company supplies various drug products to domestic and international clients. Regulatory Affairs, Sales, Marketing and other administrative functions as well as Formulation R&D are conducted through our head office and laboratories in Tehran. Material Management, Quality Control, and Manufacturing are located in two separate factories in Kaveh Industrial Park 90 km south of Tehran.
  • Avicenna was granted a Science-Based Company status by the Office of the Vice President for Research and Development in 2016. This was based on Avicenna’s record of excellence in Research and Development as demonstrated in scientific publications and international patents.
  • Avicenna was the recipient of the Technology-Quality Award in Pharmaceutical Industry by European Union (ICS Group).

 

Research and Development 

  • The Most important facet of our overall operation.
  • Comprised of a core of Ph.D. and M.Sc. chemists, 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 universities.
  • 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.
  • Over 40 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 formulations (non-infringing) for the reduction of GE side effects as well as improved patient compliance.
  • Development of non-infringing process patents based on client’s specifications.

                                                                                           

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 matters.

 

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.

 

 Facilities

  • 20,000 sq. meter complex includes process and formulation development and QC laboratories, Material Management, Production, Packaging, Utilities, water purification (RO), Water Treatment and raw material and finished product Warehouses.
  • State-of-the-art equipment and all other requirements for the production of solid dosage forms of drugs.
  • Extensive water treatment facility.
  • Consistently lower levels of BOD and COD of effluent water than those required by the Environmental Protection Organization.

 

Regulatory Affairs

  • Plant Master File (Type I) and Drug Master File (Type II) on all products in eCTD format.
  • Submission of the open portion of DMFs in eCTD format to clients for Regulatory Affairs.
  • DMF submission in eCTD format to regulatory authority for product registration.