NEW DELHI, India, (April 18, 2024) – Dishman Carbogen Amcis Ltd received the Choose France-Best Indian Investment in France award by the Indo French Chamber of Commerce & Industry in partnership with Business France India, at the sixth flagship event of the Indo-French Business Awards (IFBA) and Grand Prix VIE, in New Delhi. His Excellency Mr. Thierry Mathou, Ambassador of France presented the award which recognises Dishman’s investment in a new state-of-the-art facility in Saint Beauzire, France, and the increase in Human Capital over the last few years.

Giving a detailed overview of the company's facility in Saint Beauzire and future business plans, Mr. Harshil Dalal, Group CFO - Dishman Group, stated:

“We thank the Indo French Chamber of Commerce and Industry for this wonderful recognition of our efforts to make France our destination of choice to do business."

Dishman Carbogen Amcis Ltd stands as a beacon of innovation and progress in the healthcare industry, transcending borders with our multi-site transcontinental presence. With 11 manufacturing sites and 6 sales offices spread across 6 countries, and subsidiaries in key regions like Switzerland, France, Netherlands, UK, and China, we're poised to deliver comprehensive healthcare solutions like never before.

Our journey in France epitomizes our commitment to growth and excellence. In 2012, we acquired a small but promising company, igniting a transformative journey in the realm of Sterile Investigational Medicinal Products (IMPS). Specializing in complex compounds, this facility became a nucleus for innovation, crafting aseptic drug products for preclinical and clinical batches in various forms.

Fast forward to 2023, a milestone year as we inaugurated our state-of-the-art facility in Saint Beauzire. With a Euro 58 million investment, this cutting-edge 9500 m2 establishment symbolizes our dedication to pushing boundaries. Operational since October 2023, it hosts over 100 skilled professionals, a testament to our commitment to job creation and skill development.

Our growth trajectory is not just about numbers; it's about impact. From a modest headcount of 34 in 2018-19, we've surged to 120 by March 2024, with sights set on reaching 200 by March 2028. This expansion isn't just about revenue; it's about societal contribution. From Euro 5 million annually to a projected Euro 40 million, our growth isn't just corporate—it's communal.

Beyond financial gains, our France site embodies potential. It's a gateway to new markets, a hub for R&D, and a catalyst for groundbreaking therapies like anti-cancer drugs. As we expand, so does our organizational backbone, with 70 new positions created, heralding a future brimming with opportunities.

Reflecting on our journey, we've come a long way from our humble beginnings. Yet, amidst our growth, the most profound transformation is the confidence we hold in the future—a future shaped by relentless innovation, unwavering dedication, and boundless potential."

Gujarat, India - After a successful on-site inspection, Ahmedabad-based Dishman Carbogen Amcis Ltd (DCAL), receives the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) certification.

DCAL’s drug substances manufacturing facility located in Bavla, underwent an inspection by the Japanese Health Authority. We are glad to announce that the inspection ended satisfactorily, and no major or critical observations were reported. As a result, PMDA recently awarded the company with the certification of GMP compliance. We are proud of this achievement which is an acknowledgement of our efforts toward maintaining current Good Manufacturing Practices (cGMPs). This certification reaffirms our commitment to improving the health of people all over the world.

We take this opportunity to heartily congratulate our teams and laud their sincerity and dedication that led to this positive outcome.

Speaking about the PMDA certification, here is what our COO, Mr. Paolo Armanino, said: “First of all, we would like to thank PMDA for their time and invaluable feedback. We feel proud to continue to be approved by the Japanese Authority. I would also like to extend my heartfelt congratulations to all the team who made this remarkable achievement possible.

We maintain strategic ties with our Japanese customers, and we recognize the company's responsibility to work closely together to improve patient health and safety. Dishman Carbogen Amcis Ltd supplies several critical drugs to the Japanese market, and we see several significant and positive developments in our business in the upcoming years.

Going forward, we aim to further expand our services and products portfolio in Japan to fulfil the customer’s needs. In order to closely engage with the demands and requirements of the Japanese market, we are thrilled to be visiting Tokyo in a few weeks for CPHI Japan, and look forward to meeting our existing and prospective valuable customers and partners.

Gujarat, INDIA (March 2024) – Ahmedabad-based Dishman Carbogen Amcis Ltd (DCAL), a pharmaceutical API manufacturing and drug development company receives the USFDA certification after a successful inspection of its manufacturing facility in Bavla.

The inspection conducted by the United States Food and Drug Administration (US FDA) at Dishman Carbogen Amcis Ltd's facility in Bavla, Ahmedabad, which was scheduled from March 4 to March 8, 2024, was successfully completed on March 7, 2024.

The inspection concluded with several procedural observations, which will be addressed within the established timelines. It is noteworthy that no significant issues were identified throughout the inspection process. The USFDA granted Dishman the Establishment Inspection Report (EIR) to close the inspection.

Consequently, the company’s facilities in both Bavla and Naroda in India, as well as its multiple facilities in Switzerland and the Netherlands, continue to maintain approval from the US FDA.

Dishman’s Chief Operating Officer, Mr. Paolo Armanino stated, “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.”

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.”