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.

In addition, the USFDA approval adds tremendous value to the Dishman brand. Respected across the world, the USFDA accreditation instils a sense of great accomplishment and illustrates the quality of our standards, operations, and processes. To see our efforts come to fruition after a complex yet rewarding journey makes us very proud.

The cessation of manufacturing operations, resulting from the EDQM’s observations in 2020, coupled with the COVID-lockdown, posed grave challenges for us. However, with the right leadership approach and strategies, we were able to overcome these hurdles successfully. Since 2020, DCAL has undergone an extensive remediation programme which included major organisational changes, a thorough assessment of employees’ qualifications and capabilities, assessment of material management, and the execution of the CAPA plan.

Simultaneously, we gradually restarted the manufacturing of certain products after risk mitigation, by ensuring short interim controls availability and with the consent of the respective customer, and even the national competent authority whenever required.

The Company also invested a significant amount of resources towards building pivotal infrastructure such as a new QC lab, Stability Chambers, Effluent Treatment Plant (ETP), a water purifier plant, etc. In addition, we also made significant modifications to the existing warehouses to optimise material management. Dishman also engaged with external agencies and brought additional quality consultants on board to support and strengthen our remediation efforts.

The remediation activities combined with the challenges of the pandemic were extremely daunting. However, it was our endeavour to see a holistic transformation of the company. With cohesive and collective efforts and action in the right direction, I am happy to state that we are realising our vision.

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 achieving 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.”