DOTTIKON EXCLUSIVE SYNTHESIS AG provides chemical custom manufacturing services to scale up from grams to multi-tons, including routefinding, process design, process development, small-scale and pilot production, manufacturing, qualification and validation services.
DOTTIKON provides its customers with exclusive custom manufacturing services. The research and development efforts are optimized to allow for flexible and fast responses to customers needs. The streamlined decision process, the ability to ramp up production quickly and the state-of-the-art plants and equipment operated by highly-trained employees allow DOTTIKON to achieve its customers ambitious targets. DOTTIKON seeks to further expand on this platform by continuously improving the quality and efficiency of the production process based on the experience of a close exclusive interaction with customers, with whom DOTTIKON establishes unique and long-term relationships.
DOTTIKON is specialized in hazardous reactions. A 110-year history in handling explosives in the past makes DOTTIKON one of the most experienced partners in the industry for critical exothermal reactions such as nitrations, oxidations and azide chemistry, to name only a few. DOTTIKON's core technologies include hazardous, low-temperature and high-pressure reactions as well as continuous processing such as catalytic hydrogenations, alkylations, halogenations, Grignard and other metallorganic reactions.
DOTTIKON EXCLUSIVE SYNTHESIS AG bases its operations on well-established and proven project management processes that are consistent with a sound quality management system.
Project/Product Managersare entrusted with the technical lead of the projects, while Business Development Managers take care of all commercial matters. The Steering Committee that involves the CEO and Senior Management regularly monitors and controls the progress of each project in order to ensure seamless project execution and the fulfillment of challenging customer requirements and high quality standards. This project governance structure in combination with highly skilled and experienced specialists ensures the safe and reliable achievements of project objectives.
Characteristics and benefits of DOTTIKON's project management
DOTTIKON EXCLUSIVE SYNTHESIS AG has more than 40 years of experience in the production of active pharmaceutical ingredients (APIs). DOTTIKON is FDA and EMA approved. DOTTIKON's technology portfolio is built around APIs to enable scale-up, high-quality and cost-effective manufacturing under cGMP requirements from kilograms to multi-tons. The processes fulfill the ICH guidelines.
Experience and services
DOTTIKON EXCLUSIVE SYNTHESIS AG develops and commercializes proprietary, high grade performance chemicals for a wide range of industrial applications in close partnership with its customers.
DOTTIKON Performance Chemicals platforms and selected applications:
Aromatic and Alicyclic Diamines for
Bio-based Organosilanes for
Phlegmatized Azides as precursors for
The Nitrosamine Risk Assessment is based on a product specific and systematic theoretical evaluation of the nitrosamine risk level (EMA and FDA guidelines) including
If the risk regarding the presence of nitrosamines in a particular API is found to be significant, confirmatory testing using state-of-the-art equipment is performed
A detailed report is provided to support marketing authorization holder's obligation regarding assessment of nitrosamines in drug products
|Liquid Chromatography with Single Quadrupole Mass Spectrometer|
|Liquid Chromatography with Quadrupole Time of Flight High Resolution Mass Spectrometer|
||Gas Chromatography with Single Quadrupole Mass Spectrometer|
||Gas Chromatography with Quadrupole Time of Flight High Resolution Mass Spectrometer|
Different occupational exposure limits require different safety measures to handle APIs. DOTTIKON's experience ensures a safe handling of all processes involved.
To handle active substances, DOTTIKON has state-of-the-art containment concepts on all scales (e.g. closed charging / handling / discharging, full protection suit, monitoring, WIP/CIP cleaning, and cleaning validation). These concepts are applied by highly skilled and regularly trained staff.
cGMP and other higher industry quality standards are an integral part of the comprehensive quality system of DOTTIKON EXCLUSIVE SYNTHESIS AG's independent Quality Management department.
DOTTIKON meets the high quality requirements of its customers thanks to the strict adherence to a quality system based on the process approach of ISO 9001:2015, which includes cGMP according to ICH Q7 as well as safety, health and environmental (SHE) protection.
DOTTIKON is authorized by Swissmedic (Swiss Agency for Therapeutic Products) to manufacture and sell active pharmaceutical ingredients (APIs) including liquid and solid dosage forms. It is subject to regular inspections by the Regional Medicines Inspectorate of North-Western Switzerland. The most recent audit was completed in February 2022.
The Quality Management system is based on a 3-level hierarchy
As part of the company's Quality Management, the Quality Control unit is responsible for testing raw materials, intermediates and final products to ensure compliance with specifications. The process analytics unit is responsible for in-process tests as well as release of cleaning results. The Quality Assurance unit monitors compliance with cGMP requirements such as review of batch records. Activities such as cleaning and process validation are performed by the responsible Quality Management project manager.
Active Substance Master Files (ASMF) or Drug Master Files (DMF) are prepared in the new eCTD format and are registered with the respective authorities worldwide
DOTTIKON's most recent FDA inspection was completed in December 2022.