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Niche APIs for Pharmaceutical Industries

Niche APIs for Pharmaceutical Industries

Commercial APIs

Dishman Carbogen Amcis Ltd has developed and manufactured several niche and high added-value Generic APIs in specific therapeutic fields. Our product portfolio focuses on complex intermediates and APIs and covers specific therapeutic areas such as anesthetics, contrast media agents for diagnostics, ophthalmic treatments, laxatives, organophosphate antidotes.

Our goal is to be a reliable partner with a strong know-how in API production and committed to manufacturing the highest quality APIs for our clients, with:

  • local client support
  • facilities approved by globally recognized health agencies
  • expertise in process optimization and commercial scale-up into cGMP manufacturing
  • worldwide distribution in both regulated and semi-regulated markets
  • RSMs captive manufactured to ensure regulatory compliance
  • open and flexible approach to customers' needs
  • extensive regulatory approval expertise: in-house preparation and submissions of DMFs in EU /USA and several countries worldwide
  • expertise in particle size distribution & micronization capabilities enable us to meet customer's specification of particle size

Research & Development

Our highly skilled and motivated Research and Development team have a passion for optimizing chemistry and analytical processes to ensure that we can introduce products rapidly, compliantly, and offer the appropriate value to our clients and ultimately to patients.

We operate continuously on a 3 shift / 6 days per week basis within R&D operations with strict IP protection policies with an almost unrivaled range of chemistry capabilities & expertise, allowing us to offer non-infringing processes.

Our services and products are focused on providing the best possible value on a long-term basis to our clients.

Saleem Shaikh – General Manager – International Marketing

“8 challenging years, gained enormous respect from clients while at Dishman Carbogen Amcis Ltd, on account of excellent product quality, an upbeat RA/QA/QC/production, and with state-of-the-art digital support, I was able to gather in-depth knowledge on new and upcoming molecules to recommend to management. All-in-all, this has been the best journey of my life.”
Saleem Shaikh – General Manager – International Marketing

Product List

Disinfectant APIs

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Enabling Services

Enabling Services

Innovation, Expertise & Security of Supply

We inherently understand that our business can only be considered a success when our customers flourish. We invest our energies engaging with customers, seeking to fully understand their needs and provide tailored and integrated solutions, combining successes in meeting client goals, ensuring the highest quality, and maintaining stringent health and safety standards.

The success of any project results from the productive cooperation between our experienced and motivated colleagues focused on meeting the clients' goals. Our commitment is to deliver high added-value solutions with technical excellence and to be a reliable and essential partner to our customers, protecting their interests as if they were our own.

Project Management

Our facilities are regularly inspected by multiple regulatory authorities, ensuring all sites operate to the highest international standard of quality, safety, and environmental control.

We have a dedicated project management team, recognizing the diversity of our clients by deploying a flexible approach to all projects, with local representation and support in all territories. This allows intimate cooperation with all customers during all stages of project reviews, along with bespoke and customized solutions suited for each case and scenario.

Risk Management

Dishman Carbogen Amcis Ltd invest in strong, tenured leadership at both corporate and local levels, operating under strictly robust and secure protection policies that assure protection of our clients' Intellectual Property (IP) at every stage of the management process.

Supply Chain Management

Our Supply Chain Management team sources raw materials, facilitating secure transfers, managing storage, and a rapid supply; ensuring timely delivery to all of our customers while maintaining full compliance with all safety and regulatory standards.

The Dishman Carbogen Amcis Ltd global supply chain presence, backed by nearly 40 years of experience, helps us secure materials within prescribed times and at the best value.

With local teams in India, the United Kindom, Switzerland, China, and Holland, we can ensure understanding and compliance with the often complex regional requirements & local storage - giving flexibility in deliveries and the reduction of cross border customs costs while ensuring our clients' materials arrive where and when they are needed.

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Dishman Carbogen Amcis Ltd

A Leading Outsourcing Partner to the pharmaceutical industry

Welcome to Dishman Carbogen Amcis Ltd!

We are a global outsourcing partner for pharmaceutical companies, offering a portfolio of products and development, scale-up and manufacturing services. The Dishman Group continually invests in the pharmaceutical industry, ensuring our businesses can provide pharmaceutical customers with high-value, high-quality products and services today and in the future. Our focus is to add value to the global pharmaceutical industry by serving as a reliable partner. We strongly believe that our business is successful only when our customers are successful.

Our Mission

The mission of Dishman Carbogen Amcis Ltd and its fundamental purpose is to offer support and assistance to people across the world suffering from illness and disease, striving to ensure that this is completed efficiently, comprehensively, and effectively.

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Key Figures

10 sites in India, Switzerland, UK, France, Netherlands & China
30 years of experience in clinical API development
100 metric tons scale manufacturing for API production
1150 m3 of capacity for API production
300 metric tons of disinfectant APIs manufactured and exported to fight COVID-19 since 03/2020
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About Us

About Us

Supporting The Pharmaceutical And
Healthcare Industries

We have been supporting the pharmaceutical and healthcare industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world.

Our Vision

Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.

Our Focus: Client Satisfaction

Dishman Carbogen Amcis Ltd focusses on the reduction of operational risk in chemical development and commercial manufacturing by:

•• Minimising the time associated with drug development
•• Decreasing the risks associated with drug development
•• Providing long-term and value-added contract manufacturing solutions

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Quality and RA

Quality & Regulatory Affairs

Unrivalled regulatory experience with a dedicated commitment to quality

Our company operates to the highest international standards of quality. Our teams are committed to delivering a quality service at each stage of a process from development through to commercial manufacturing, delivering high-quality products at all times.

Quality by Design techniques and the effective use of formal risk management processes are used to define and steer a compliant product strategy that controls and mitigates risk.

Our facilities are regularly inspected by national and international regulatory authorities as well as our clients.

Quality Assurance

  • We operate both classical and lifecycle validation approaches following FDA guidelines.
  • Our focus is on Expediting product filings through the registration batch approach.
  • Services supported by Product quality risk assessments.
  • Strict procedures support Document control both in issuance and through robust archival policies.

Our policies support our clients' active involvement to ensure that no risk occurs in the process of bringing new drugs to market. 

Regulatory Affairs

Our highly experienced team can offer complete API regulatory support from initial submission to market authorization:

  • We have extensive experience in the preparation and submission of:
    • DMFs for EU/US and several other countries and continents.
    • EP-Certificate of Suitability (CEP).
  • Our team also helps our clients in post-approval support activities, including update and variation changes of DMFs & CEPs.
  • Our flexible approach in addressing our clients' needs has resulted in many successes and is focused on continuing this track record.
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