The manufacturing processes of Letrozole (CAS 112809-51-5), Erlotinib Hydrochloride (CAS 183319-69-9), Imatinib Mesylate (CAS 220127-57-1) and Sunitinib Malate (CAS 341031-54-7) are fully developed, and robustness and reproducibility have been demonstrated through the production of pilot batches on the scale of hundreds of grams. The products obtained through these processes meet the quality attributes defined by the European and US pharmacopoeias or, in the case of non-pharmacopoeial APIs, in accordance with ICH Q6A guide. The packaging system and suppliers of all materials have been defined; stability studies were conducted in accordance with ICH Q1A and Q1B guidelines, and meet climatic zones I and II and IV-B. Specialità Fine Chemicals is interested in these APIs´ manufacturing technology transfer.

The manufacturing process of Cannabidiol API is based on chemical synthesis, that is, the product is obtained through chemical reactions that modify the structure of simpler substances, so-called starting materials, until it reaches the chemical structure of the API. The starting materials were defined in accordance with the ICH Q11 guideline.

Cannabidiol API manufacturing process was transferred to Prati-Donaduzzi API production unit, which, after inspection by the Brazilian Health Authority (ANVISA) in November 2018, was approved for the beginning of the industrial production.

Moreover, ANVISA, through Resolution RE 4.255 of 10/21/2020, certified that Prati-Donaduzzi´s manufacturing facility of Active Pharmaceutical Ingredients (APIs) complies with the guidelines of Good Manufacturing Practices (GMP) issued by Brazilian legislation, which is in line with the recommendations of the World Health Organization. It is noteworthy that Anvisa has been developing partnerships and technical cooperation with other Health Authorities, such as in Mercosur Member States, Cuba, Swissmedic and EDQM (European Directorate for the Quality of Medicines & Healthcare) as well as becoming a member of the ICH and the PIC/s, which demonstrates the convergence of our regulation with international standards.

There is no monograph for Cannabidiol API in the European and US pharmacopoeias; for this reason, the quality attributes were defined in accordance with the ICH Q6A guideline. The quality attributes and their specifications are available for viewing at this link.

The technical documentation of the product, which is called DMF - Drug Master File, was drawn up in accordance with the ICH M4Q guidance, as well as Anvisa’s RDC no 359/2020. Stability studies were conducted in order to address climatic zones I and II, and also IV-B.