Qualification

Our accumulated experience of over 30 years in the market, meeting different and strict requirements in the over 100 countries in which we serve, has brought us to structure a strong management system, capable to guarantee the high quality of our products in every stage from manufacturing to supply as well as global technical support on how to use our raw materials, development of new formulations, reformulations and product scale-up.

Our products are produced under the strictest quality standards and according to the Good International Manufacturing Practices, complying with the main official compendiums, such as:

  • United States Pharmacopoeia (USP/NF)
  • European Pharmacopoeia (EP)
  • Japanese Pharmacopoeia (JP)
  • British Pharmacopoeia (BP)

Our practices and procedures are periodically audited and approved by Brazilian and international clients, official agencies and independent audit firms.

Currently, in the certificate and declarations format, we have:

Excipients & Ingredients
  • ISO 9001:2008
  • DMF (FDA – EUA)
  • FSSC 22000
  • Halal
  • Kosher
  • SMETA
  • Non-GMO
Finished Dosage Formulations
  • ANVISA GMP (Brazilian Regulatory Agency)
  • Undergoing certification: Europe, WHO, Health Canada and FDA.
Active Pharmaceutical Ingredients (APIs)
  • ANVISA GMP (Brazilian Regulatory Agency)