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First CADIFA certification from ANVISA for Etodolac

In the dynamic landscape of pharmaceutical regulations, Brazil took a significant stride in April 2020 when ANVISA unveiled new rules about active pharmaceutical ingredients (APIs). Fast forward to August 2020, and these regulations officially became effective in Brazil’s vibrant pharmaceutical market. As we approach August 2023, a pivotal moment awaits – enforcing these regulations. From this juncture onward, any domestic or international company seeking to register drug products in Brazil must secure a CADIFA.

What the CADIFA is?

A letter from ANVISA, the CADIFA, signifies the approval of the DIFA (Active Pharmaceutical Ingredient Dossier or the DMF). ANVISA issues the CADIFA after a meticulous evaluation of the DIFA, ensuring it aligns with the stringent standards outlined in the new set of regulations: RDC 359/2020, RDC 361/2020, and RDC 362/2020.

Why is CADIFA so crucial?

Certification brings many advantages for organizations navigating Brazil’s intricate drug registration process. Notably, it provides a coveted certificate of Good Manufacturing Practice (GMP) compliance to API manufacturers in Brazil – a prerequisite for registering medicinal products in the country.

A strategic move that saves time and resources

One of the notable perks is that once a CADIFA is authorized, it is a powerful tool, supporting multiple drug product registration applications. The beauty lies in its efficiency; there’s no need for the burdensome re-evaluation of the Drug Master File (DMF) for each application.

The CADIFA registration procedure parallels the CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia) procedure of the European Directorate for the Quality of Medicines (EDQM). However, the CADIFA stands unique – it doesn’t bind to any specific monograph.

Our commitment to excellence in pharmaceuticals

Embarking on the journey to attain a CADIFA is a challenging feat. It involves an extensive process, including an on-site Good Manufacturing Practice (GMP) inspection and a thorough DMF assessment. This assessment dives deep into the intricacies of the supply chain, manufacturing processes, and API quality. It’s a journey that demands meticulous attention, but the reward is clear – a testament to the highest standards of GMP production and the quality of Etodolac. An assurance that echoes beyond the regulatory landscape and resonates with the commitment to excellence in pharmaceuticals.

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