Active Pharmaceutical Ingredients (APIs) are at the heart of modern medicine and form the basis of many effective and innovative therapies, both existing and in development. Protheragen-ING supports the pharmaceutical industry by providing a comprehensive range of API services. With our state-of-the-art facilities, experienced team and commitment to quality, we offer a range of solutions for API development, manufacturing and analytical testing. Our goal is to assist pharmaceutical companies in bringing safe, effective and high-quality drugs to market.
About APIs
APIs are key components of a drug's therapeutic efficacy and have specific pharmacological properties for a particular disease or condition. They come from a variety of sources, including chemical synthesis, fermentation, or extraction from natural substances. They are subject to rigorous testing and quality control measures to ensure their safety, efficacy, and compliance with regulatory standards.
APIs play a vital role in the pharmaceutical industry and are fundamental to the development and manufacture of medicines. They are used in a wide range of medicines, including tablets, capsules, injections, creams, and more.
Comprehensive API services
Protheragen-ING is designed to meet the specific needs of pharmaceutical companies and support their drug development and commercialization efforts. By partnering with us, you gain access to our expertise, state-of-the-art facilities, and commitment to quality, allowing you to focus on your core competencies while ensuring the highest standards in API development, manufacturing, and testing.
| API Synthesis |
We offer expertise in API synthesis, utilizing various synthetic routes and techniques to develop efficient and scalable processes for the production of high-quality APIs. |
| APIs Contract Manufacturing |
Our contract manufacturing services provide end-to-end solutions for API production, including process optimization, scale-up, and commercial manufacturing. We ensure strict adherence to quality standards and regulatory requirements. |
| API and Drug Product Stability Testing |
We conduct comprehensive stability testing of APIs and drug products under various storage conditions to assess their shelf life, degradation pathways, and formulation compatibility. |
| API Stress Testing Studies |
Our stress testing studies evaluate the stability and degradation behavior of APIs under different stress conditions, such as temperature, light, humidity, and pH, to identify potential degradation pathways and develop appropriate stability-indicating methods. |
| API Physical Characteristics Testing |
We perform a range of physical characterization tests on APIs, including particle size analysis, crystal form determination, polymorphism screening, solubility studies, and solid-state characterization, to ensure consistent quality and performance. |
| Impurities in API Risk Assessment |
Our team conducts a thorough risk assessment to identify and characterize impurities in APIs. We develop strategies to control and minimize impurity levels, ensuring compliance with regulatory guidelines. |
| API and Excipients Compatibility Studies |
We evaluate the compatibility between APIs and excipients used in drug formulations to ensure stability, efficacy, and safety. Our studies assess any potential interactions that may affect the quality or performance of the final drug product. |
| API Manufacturing Process Development, Tech Transfer, and Validation |
We provide comprehensive support for API manufacturing process development, optimization, and validation. Our team assists with technology transfer from laboratory-scale to commercial-scale production, ensuring seamless and efficient manufacturing operations. |
In addition to the above API projects, we also provide customized solutions for customers' specific needs.
If you are interested in this service and need more information, contact us and we will arrange for professionals to provide you with more information and discuss your specific requirements.
