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 (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.”

Ahmedabad, India (December 9th, 2021) — Dishman Carbogen Amcis Ltd, a global outsourcing partner for the pharmaceutical industry, welcomes the results of a new Clinical Research Study which shows that oral 25-Hydroxyvitamin D3 (Calcifediol) was able to correct vitamin D deficiency/insufficiency in patients with COVID-19 and that it resulted in improved immune function by increasing blood lymphocyte percentages. The research was supervised by Tehran University of Medical Sciences and Boston University School of Medicine and supported in part by a grant from Dishman Carbogen Amcis Ltd’s wholly owned subsidiary CARBOGEN AMCIS B.V.

Dishman Carbogen Amcis Ltd (DCAL) is a leading global manufacturer of vitamin D plus its analogs and related APIs with over 70 years of experience in the field. DCAL partnered with Dr. Michael Holick, MD, PhD, professor of medicine, physiology and biophysics and molecular medicine at Boston University School of Medicine and its team for the Clinical Research Study to be run by the Tehran University of Medical Sciences on treatment with 25-Hydroxyvitamin D3 (Calcifediol) of hospitalized patients with COVID-19.

The study showed that patients receiving the 25-hydroxy metabolite had, in comparison to those receiving a placebo, a demonstrably more favorable development of their immunological defense against COVID-19. Thus, dosing the metabolite significantly increased the blood levels as well as the comparative percentage of lymphocytes in blood, i.e. a reduced Blood Neutrophil-to-Lymphocyte Ratio.

“A person’s vitamin D status is defined as the person’s blood level of the vitamin’s 25-hydroxy metabolite (Calcifediol), i.e. the vitamin’s natural form in circulation which the body can quickly access and finally activate. Therefore, Dishman Carbogen Amcis Ltd has for years studied the effects of dosing either the vitamin and/or the metabolite. Said Dr. Scott Miller, Sr. Scientific Advisor at DCAL, “Our support of this study of Calcifediol in the context of COVID-19 was motivated by the fact that the blood level of the metabolite can be increased more rapidly and more distinctly, if supplemented directly.”

To support the Clinical Research Study CARBOGEN AMCIS B.V. (Netherlands) provided the Active Pharmaceutical Ingredient (Calcifediol) and the capsules and placebo were made at Dishman Carbogen Amcis Ltd’s plant in Bavla, India, specifically for this study.

“There are several studies that have reported that a good vitamin D status i.e. a healthy blood level of 25-hydroxyvitamin D, can not only dramatically reduce the risk of being infected by this deadly virus but also a higher vitamin D status reduced risk for serious symptoms and death caused by the virus.” Commented Dr. Michael Holick. “This controlled study similar to the one conducted in Spain recently ^[1] demonstrate that the rapid improvement in vitamin D status can improve positive outcomes for patients infected with COVID 19.”

“The COVID-19 pandemic hitting the world in early 2020 resulted in unprecedented global focus of R&D efforts and of solidarity in coping with the sudden and unexpected high need for intensive care beds, which didn’t hit all countries to the same degree.” Said Arpit Vyas, Global Managing Director of Dishman Carbogen Amcis Ltd: “It is important for us to play a role in this new challenge, not only for our corporate interests but to contribute to the possible future of the fight against COVID-19. Therefore, to follow up with this Clinical Research Study, Dishman Carbogen Amcis Ltd is currently conducting a second round of study in a larger scale in India.”

For more information about the study supported by Dishman Carbogen Amcis Ltd:
https://www.sciencedirect.com/science/article/pii/S1530891X21012593

^[1] “Effect of Calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study”
https://www.sciencedirect.com/science/article/pii/S0960076020302764

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Dishman Carbogen Amcis Ltd (www.imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Carbogen Amcis Ltd., Ahmedabad, India.

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Ahmedabad, India (May 21th, 2021) — India-based Dishman Carbogen Amcis Ltd, a global outsourcing partner for the pharmaceutical industry, welcomes the results of a new study that provides critical insights into the treatment of vitamin D deficiency in obesity and in fat malabsorption syndromes. The research was conducted by Boston University School of Medicine and supported in part by a grant from Dishman Carbogen Amcis Ltd’s wholly-owned subsidiary CARBOGEN AMCIS B.V.

Dishman Carbogen Amcis Ltd (DCAL) is a leading global manufacturer of vitamin D analogs and related APIs. DCAL partnered with Dr. Michael Holick, MD, Ph.D., professor of medicine, physiology, and biophysics and molecular medicine at Boston University School of Medicine, to determine whether alternative vitamin D-type substances provide significant health benefits in people suffering from impaired distribution and metabolism of vitamin D.

“We believe that partnerships with academic institutions help uncover important insights and make great discoveries that benefit the pharmaceutical industry and, most importantly, the patients directly”, said Arpit Vyas, Global Managing Director of Dishman Carbogen Amcis Ltd.

The study results will benefit obese people and, e.g., patients who have undergone gastric bypass surgery, which quite generally results in vitamin D malabsorption. Thus, those patients run an elevated risk of bone diseases like osteoporosis and osteomalacia due to softening of the bones.

Researchers observed that a form of vitamin D, known as 25-hydroxyvitamin D3 (Calcifediol), was absorbed faster and better than the same dose of vitamin D. “This vitamin D metabolite is better absorbed in patients with fat malabsorption syndromes and since it is not as fat-soluble, it does not get diluted in the body fat and is effective in raising and maintaining blood levels,” said Dr. Michael Holick. “Therefore, using 25-hydroxyvitamin D3 could be a novel approach for treating vitamin D deficiency in patients with fat malabsorption syndromes.”

CARBOGEN AMCIS B.V. provided the 25-hydroxyvitamin D3 capsules, which were produced at its parent company Dishman Carbogen Amcis Ltd’s Bavla facility in Ahmedabad, specifically for this study, thus becoming yet another global project for DCAL.

With over 70 years of vitamin D experience, DCAL is one of the leading innovators, developers, and manufacturers of vitamin D and its analogs. DCAL is engaged in these activities both at the DCAL location in Ahmedabad, India, and at its CARBOGEN AMCIS B.V. location in the Netherlands which is also active in the production and sales of vitamin D analogs (e.g., Alfacalcidol, Calcifediol, and Calcitriol), Ergocalciferol, and Cholesterol and lanolin related products for key markets as pharmaceutical, cosmetic, food, feed as well as industrial applications. DCAL manufactures raw material for vitamin D ingredients and develops a range of vitamin D analogs and metabolites which are used as APIs in pharmaceutical products across the world.

“Our Vitamin D activities are a source of particular pride. Since 2007 when the Netherlands facility was acquired by DCAL we have continually invested to ensure that we remain at the forefront of innovation. Our industry partners rely on the quality of the APIs we deliver. Through this collaboration with Boston University School of Medicine, we sought to advance our industry’s understanding of the full potential of vitamin D supplements for patients with various needs,” said  Rob Eijkman, site director CARBOGEN AMCIS B.V., Netherlands.

“The collaboration with Boston University and Dr. Holick has been an exercise in complete focus upon patients of need and efficient solutions to meet that need,” commented Dr. Peter Müller, senior scientific advisor for DCAL. “Dishman Carbogen Amcis Ltd has worked closely with Boston University School of Medicine on investigating the roles that vitamin D substances play in humans. In addition to the results of the study addressed here, the partnership has resulted in a mutually beneficial exchange of scientific views, including participation by Dr. Holick in scientific forums at DCAL.”

For more information about the Boston University study supported by Dishman Carbogen Amcis Ltd: https://academic.oup.com/ajcn/advance-article-abstract/doi/10.1093/ajcn/nqab123/6277980?redirectedFrom=fulltext

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Dishman Carbogen Amcis Ltd (imdcal.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up, and manufacturing services. Dishman Carbogen Amcis group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and in India.

CARBOGEN AMCIS AG (www.carbogenamcis.com) is a leading service provider offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries across all stages of clinical development and product life cycle. Our integrated services and innovative chemistry solutions support timely and safe drug development, allowing customers to better optimize available resources. CARBOGEN AMCIS is a wholly-owned subsidiary of Dishman Carbogen Amcis Ltd, Ahmedabad, India.

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