We inherently appreciate that developing robust analytical methods is a fundamental element of bringing a new drug substance to market. This capability is driven by dedicated analytical chemists with real-world, actionable experience using state-of-the-art technology.

With over 30 years of experience in API development and an in-house comprehensive range of analytical capabilities, we can support our customers with their projects at any stage throughout all clinical phases and into commercial production.

• Characterization
• Absolute Configuration
• Polymorphism
• Particle Sizing
• Compatibility
• Impurity Profiling
• Solid-State Characterization – DS

• Product-specific analytical methods are established for process control, product release, and intermediate/raw material releases
• Impurity tracking
• Reference standard characterization
• Specification development,
• Method transfer and validation
• Stability studies performed according to ICH guidelines
• Force degradation studies

Dishman Carbogen Amcis Ltd has a wide range of analytical equipment available across all sites and available for our use. 

• HPLC (DAD, UV, RI)
• Ion chromatography
• HPLC-MS
• GC (FID, NPD)
• GC (Headspace) 
• GC-MS
• TLC with scanner

• NMR 400 MHz
• FTIR
• ICP-MS
• CHN
• XRD
• UV-Spectrophotometers
• Polarimetry ok

• Malvern particle sizer
• Microscopy
• DSC
• Autotitrators

We aspire to continually improve and innovate to provide the highest standards of quality, reliability, timeliness, underpinned by a wide range of capabilities in an ever-diversifying environment and range of localities to meet clients' needs.

•• Development is the foundation of our service
Our objective is to develop smart, efficient, cost-effective, and sustainable processes that enable our clients to treat disease more rapidly and benefit the global population. Our clients can move through pre-clinical and into the clinical phases with our delivery on to registration, validation, and ultimately commercialization of their NCEs.

Our scientists, supported by dedicated project managers, ensure the provision of our multi-faceted services in a compliant and timely manner; incorporating process development and optimization while anticipating scale-up issues with a systematic approach including Quality by Design methods and the effective use of formal risk management processes to define and steer the product control strategy.

•• Commercial Manufacturing
Since our foundation, our mission has been to be a continually trusted and consistently reliable partner to our international clients. We are recognized for our thorough technology transfer process and project management skills. Our premium capabilities, from small to large volumes, with the ability to deploy a comprehensive range of capabilities, including hydrogenations, ozonolysis, high temperature, and cryogenic capacities, differentiate us and our dependable services. With over 30 years of experience in handling custom manufacturing projects worldwide, our clients profit from our experience, skills, and services time after time.

•• Highly Potent (HiPo) APIs
Dishman Carbogen Amcis Ltd has extensive experience and substantial capability in helping customers bring highly potent drugs to patients. We facilitate the effective and safe development and routine commercial manufacture of APIs under cGMP, with upstream integration to intermediates and key raw materials (KRMs) to manage supply chain risk and product life cycle management. All capabilities are underpinned by a world-class occupational health system for product and personnel protection.

QUICK LINKS

•• Soft Gel Capsules
Dishman Carbogen Amcis Ltd, with an unrelenting focus on pursuing innovation in healthcare, has set up a state-of-the-art Soft Gels manufacturing facility. Its core lies in its CRAMs model capabilities that includes all the services ranging from R&D, F&D, commercial manufacturing, and private labeling for Nutraceuticals and Pharma Grade Vitamin D formulations

•• Healthcare & Hygiene products
Dishman Carbogen Amcis Ltd is committed to providing effective and innovative solutions for the health and hygiene sectors and helping create disease-free environments. Our state-of-the-art, modern liquid formulation facility is equipped to meet international quality standards. Products can be manufactured in different packing, colors, or fragrances according to customers' requirements and private labels.

•• Dishman Carbogen Amcis Ltd Delivers innovation, expertise, and the security of supply
Our business is a success only when our customers are successful! We invest in time engaging with customers, understanding their requirements, and providing tailored individual packages, ensuring the highest quality while following strict health and safety standards. The success of our projects is the result of the productive cooperation between our experienced teams and departments.

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.

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

•• Project Management
Dishman Carbogen Amcis Ltd has local representation and support in all major markets. Dedicated and highly skilled project managers deliver rigorous project management procedures. Communication and associated reporting are tailored to match customer-specific requirements.

This means our thorough technical transfer processes have been tested and verified in many hundreds of projects run over decades across the world.

•• Risk Management
We invest in strong, tenured leadership at corporate and local levels, at many sites, in multiple country locations.

Dishman Carbogen Amcis Ltd operates under strictly robust and secure IP protection policies, offering a global supply chain and full international logistics support.

•• Regulatory Affair
We can offer complete API regulatory support, including substantial experience in generating DMFs and ECOS.

•• With an extensive range of skills, experience, and capabilities, we can develop and manufacture innovative products

Our extensive knowledge, production excellence, and unrivaled capability to handle a wide range of technologies mean our products are manufactured to meet the highest international quality standards.

Disman Carbogen Amcis operates facilities approved by globally recognized health agencies, and we have expertise in process optimization and commercial-scale cGMP manufacturing.

With a global presence and proximity to our clients, we provide local support and regulatory expertise in all markets - offering product support, DMFs development, and product regulatory filing services.

There is increased demand in the market for highly potent API due to increased oncology research and more targeted treatments across several indications. This is why the Dishman Carbogen Amcis Ltd Group has invested in world-class capabilities to address the oncology and other highly potent compound therapy markets.

The Group has a strongly differentiated set of in-house capabilities in the HiPo API arena, underwritten by a consolidated project management capability to take customers from preclinical stages to commercial manufacturing of APIs I and clinical Ph2 parenteral dosage form capabilities.

Dishman Carbogen Amcis Ltd has invested around USD20 million at our Bavla India campus, creating a dedicated and segregated 4300 m2 state-of-the-art facility completed with development labs, kilo lab, and large-scale commercial plant. The plant incorporated global best practices in potent compound handling and was designed and constructed by an internal global team. The facility has scale capability from mg’s to high kg scale for manufacturing API at the highest potency levels.  

Dishman Carbogen Amcis Ltd has extensive experience and substantial capability in helping customers bring highly potent drugs to patients. We facilitate the effective and safe development and routine commercial manufacture of APIs under cGMP, with upstream integration to intermediates and key raw materials (KRMs) to manage supply chain risk and product life cycle management. All capabilities are underpinned by a world-class occupational health system for product and personnel protection.

Our facility utilizes fully closed systems providing the high level of barrier containment required to manufacture highly potent products in a safe and ecologically protected manner.

• Experienced and highly skilled, dedicated workforce.
• FDA approved GMP facility
• R & D labs, kilo lab, and dedicated QA / QC facility
• We can handle an OEL below 1μg/m3 (containment down to category 4)
• 2 Independent manufacturing Cells (Cells α and β) of 3,200L each, with 630 to 1,600L vessels
• 5 to 200kg batch size
• Process transfer and manufacturing support labs

All containment facilities are designed based on a containment concept utilizing barrier isolation technology and Rapid Transfer Ports (RTPs) and a strict zone concept with pressure cascades, airlocks, and access controls. This allows the safe handling of highly potent compounds, including cytotoxics.

• 2 R&D Laboratories with isolators (containing an over-tray) under pressure cascade for the same specs/design of the chemical plant.
• All operations involving material handling are executed in isolators/glove boxes: 
  • unpacking
  • weighing
  • transport
  • charging of reactors
  • discharging of filter dryers
  • packaging
• 3 HiPo material storage areas:
  • Dedicated storage room for HiPo intermediates and raw materials Dedicated storage room for final products.
  • Dedicated Cold Storage Room for potent products that need 2-8 conditions.

We aspire to continually improve and innovate to provide the highest standards of quality, reliability, timeliness, underpinned by a wide range of capabilities in an ever-diversifying environment and range of localities to meet clients' needs.

•• Development is the foundation of our service
Our objective is to develop smart, efficient, cost-effective, and sustainable processes that enable our clients to treat disease more rapidly and benefit the global population. Our clients can move through pre-clinical and into the clinical phases with our delivery on to registration, validation, and ultimately commercialization of their NCEs.

Our scientists, supported by dedicated project managers, ensure the provision of our multi-faceted services in a compliant and timely manner; incorporating process development and optimization while anticipating scale-up issues with a systematic approach including Quality by Design methods and the effective use of formal risk management processes to define and steer the product control strategy.

•• Commercial Manufacturing
Since our foundation, our mission has been to be a continually trusted and consistently reliable partner to our international clients. We are recognized for our thorough technology transfer process and project management skills. Our premium capabilities, from small to large volumes, with the ability to deploy a comprehensive range of capabilities, including hydrogenations, ozonolysis, high temperature, and cryogenic capacities, differentiate us and our dependable services. With over 30 years of experience in handling custom manufacturing projects worldwide, our clients profit from our experience, skills, and services time after time.

•• Highly Potent (HiPo) APIs
Dishman Carbogen Amcis Ltd has extensive experience and substantial capability in helping customers bring highly potent drugs to patients. We facilitate the effective and safe development and routine commercial manufacture of APIs under cGMP, with upstream integration to intermediates and key raw materials (KRMs) to manage supply chain risk and product life cycle management. All capabilities are underpinned by a world-class occupational health system for product and personnel protection.

QUICK LINKS

•• Soft Gel Capsules
Dishman Carbogen Amcis Ltd, with an unrelenting focus on pursuing innovation in healthcare, has set up a state-of-the-art Soft Gels manufacturing facility. Its core lies in its CRAMs model capabilities that includes all the services ranging from R&D, F&D, commercial manufacturing, and private labeling for Nutraceuticals and Pharma Grade Vitamin D formulations

•• Healthcare & Hygiene products
Dishman Carbogen Amcis Ltd is committed to providing effective and innovative solutions for the health and hygiene sectors and helping create disease-free environments. Our state-of-the-art, modern liquid formulation facility is equipped to meet international quality standards. Products can be manufactured in different packing, colors, or fragrances according to customers' requirements and private labels.

•• Dishman Carbogen Amcis Ltd Delivers innovation, expertise, and the security of supply
Our business is a success only when our customers are successful! We invest in time engaging with customers, understanding their requirements, and providing tailored individual packages, ensuring the highest quality while following strict health and safety standards. The success of our projects is the result of the productive cooperation between our experienced teams and departments.

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.

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

•• Project Management
Dishman Carbogen Amcis Ltd has local representation and support in all major markets. Dedicated and highly skilled project managers deliver rigorous project management procedures. Communication and associated reporting are tailored to match customer-specific requirements.

This means our thorough technical transfer processes have been tested and verified in many hundreds of projects run over decades across the world.

•• Risk Management
We invest in strong, tenured leadership at corporate and local levels, at many sites, in multiple country locations.

Dishman Carbogen Amcis Ltd operates under strictly robust and secure IP protection policies, offering a global supply chain and full international logistics support.

•• Regulatory Affair
We can offer complete API regulatory support, including substantial experience in generating DMFs and ECOS.

•• With an extensive range of skills, experience and capabilities we are able to develop and manufacture innovative products

Our extensive knowledge, production excellence, and unrivalled capability to handle a wide range of technologies mean our products are manufactured to meet the highest international quality standards.

Disman Carbogen Amcis operates facilities approved by globally recognised health agencies, and we have expertise in process optimization and commercial-scale cGMP manufacturing.

With a global presence and close proximity to our clients, we provide local support and regulatory expertise in all markets - offering product support, DMFs development and product regulatory filing services.