Gujarat, INDIA (January 2024) – Ahmedabad-based Dishman Carbogen Amcis Ltd (DCAL), a pharmaceutical API manufacturing and drug development company receives the CEP certification by the EDQM and the EUDRA GMP by the Italian Medicines Agency after a successful inspection of its manufacturing facility.

From (date), DCAL’s Bavla manufacturing facility underwent an inspection by the EDQM European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Union Drug Regulatory Authorities Network (EUDRA) GMP certification by the Italian Medicines Agency (AIFA).

Overall, the inspection was successful with a few minor observations reported. As a result, DCAL’s manufacturing facility in Bavla, Ahmedabad, has been granted the Certificate of Suitability (CEP) by the EDQM and the European Union Drug Regulatory Authorities Network (EUDRA) GMP certification by AIFA.

Reacting to the certifications, Mr. Paolo Armanino, COO, Dishman Carbogen Amcis Ltd stated:

“We extend our heartfelt thanks to the EDQM and AIFA for visiting our facility and awarding us the certifications of compliance. We are proud to have the CEP and EUDRA GMP certifications reinstated as a result of significant improvements in our Bavla facility subsequent to the observations by the EDQM in 2020. Since then, we have made substantial upgrades and augmented our capabilities in order to be compliant with global GMP standards.

The successful EDQM-AIFA certifications are, above all, a reinstatement of trust in Dishman Carbogen Amcis Ltd as one of the world’s leading global outsourcing partners to the pharmaceutical industry. Together, we work towards achieving one goal: patient safety and well-being. I congratulate all our teams for their tireless dedication and unwavering commitment to achieve this milestone.

 The coming years indicate a steady and upward trajectory for Dishman Carbogen Amcis Ltd and our customers across Europe. We sincerely intend to continue to meticulously research, develop, manufacture, and supply APIs, drugs, fine chemicals, etc. throughout the continent and the world.”