HTL

Our expertise

HTL’s raw material is formulated in many pharmaceutical and medical device products on the world market.

HTL is consistently making investments in R&D to improve the quality of its raw materials as well as to develop new raw materials (for example: HA oligosaccharides production).
HTL’s R&D Department puts its technology and competence in the hands of its clients by being able to supply tailor made HA to fit any particular need.

PRODUCTION AND QUALITY SYSTEM

Our Production and Quality System follows the cGMP for the manufacture of pharmaceutical active ingredients (ICH Q7A) which assures the product supply with constant quality controls and validated methods.

  • International GMP compliance
  • US FDA Inspected in 2015, 2013 and 2009 (New Drug Application and Post-Market Inspection)
  • Inspected regularly by European Authorities

 

 

PRODUCT REGISTRATION

HTL has a Master File (in CTD format) registered in many countries worldwide (for example)

  • Europe : Certificates of suitability to the European Pharmacopoiea
  • US FDA
  • Australian TGA
  • Indian MOH
  • Korean FDA
  • Russia
  • Japan

HTL’s regulatory expertise can accompany clients through market registration.