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Macsen Drugs | Now GMP certified by TGA Australia

We are delighted and thrilled to announce that our API manufacturing facility “Macsen Drugs”, which is WHO-GMP certified and US-FDA registered, has now successfully obtained GMP certification from the Therapeutic Goods Administration (TGA) of Australia.
With this, we are now also recognized as a PIC/S audited facility.

Our facility “Macsen Drugs”, manufactures a range of APIs which includes-

  • Methylene Blue USP (Methylthioninium Chloride Ph Eur / BP)
  • Silver Sulfadiazine USP
  • Selenium Sulfide USP / Ph Eur
  • Indigotindisulfonate Sodium USP
  • Selenious Acid USP
  • Fluorescein Sodium USP / Ph Eur

Moving forward, we have plans to introduce our pipeline APIs, including Deferiprone (an Iron Chelator) and Viloxazine Hydrochloride (an Antidepressant), within the same facility.

This facility also features our state-of-the-art, fully-equipped in-house R&D division capable of conducting organic and inorganic synthesis at scales ranging from milligrams to kilos. We have the latest analytical equipments like LC-MS/MS, GC-MS/MS and Prep-HPLCs. Softwares like Reaxys and Sci-Finder are used for faster development.

The TGA recognition underscores our commitment to upholding the highest standards in the production of pharmaceutical products. The GMP certification by TGA Australia is a confirmation that showcases our adherence to stringent quality control measures, rigorous documentation, and comprehensive process validation.

Our GMP certification reflects our commitment to delivering products of the highest quality, meeting and exceeding international regulatory standards. It strengthens our position as a reliable and trustworthy partner, fostering increased confidence and collaboration.

As we move forward, our commitment to excellence remains unwavering. We will continue to invest in continuous improvement, innovation, and maintaining the highest industry standards.