Hakim Pharmaceutical Technologies Company, recognized as Iran’s most specialized manufacturer of pharmaceutical secondary reference standards, successfully obtained the operating license for its new production facility in 2021 from the Reference Laboratory of the Iran Food and Drug Administration (IFDA). These products are manufactured under the FDH brand.

In response to the needs of Iran’s pharmaceutical industry and to facilitate access to reliable pharmaceutical reference standards required for drug analysis, the company has undertaken the synthesis, purification, and characterization of impurities and related compounds, as well as drug substances (active pharmaceutical ingredients). These activities are carried out in accordance with international guidelines and standards, including ISO 17025, ISO 17034, WHO, EMA, ICH, and PIC/S, with quantitative comparison against internationally recognized reference standards such as BP, Ph. Eur., and USP.

The company’s pharmaceutical reference standards production facility includes specialized synthesis and manufacturing departments, a quality control laboratory, and a cleanroom-based weighing area equipped with laminar flow hoods and HEPA filtration. Its advanced manufacturing and quality control capabilities include instruments such as HPLC, GC, UV, IR, polarimetry, and Karl Fischer titration systems.

In addition, advanced analytical techniques including ¹H and ¹³C NMR, mass spectrometry (MS), atomic absorption spectroscopy (AAS), and ICP-AES are performed through contractual collaborations with leading academic institutions, including Sharif University of Technology, the University of Tehran, and the Institute of Chemistry.

Under the continuous supervision of the Reference Control Laboratory of the Iran Food and Drug Administration, along with periodic testing and evaluation of samples over the past four years, the company has been proud to supply its products to more than 100 pharmaceutical companies.