Active Pharmaceutical Ingredients (APIs) are the components in medicines which provide the therapeutic effect. They are the primary substances that interact directly with the target in the body to treat a specific disease or condition. Also known as bulk pharmaceuticals, they play a very important role in the pharmaceutical industry.
APIs are the most essential component of a medicine, without which there would be no medicine. They serve as the foundation for formulating various dosage forms (capsules, tablets, creams, injections etc.). Pharmaceutical companies invest significant resources in researching, discovering and synthesizing new APIs or modifying existing ones to create improved medications with enhanced efficacy and reduced side effects.
When combined with other inactive ingredients, APIs create a final pharmaceutical product which is safe, stable and effective. The properties and characteristics of APIs influence the formulation design, bio-availability and overall performance of the medication. APIs are subject to regulatory scrutiny and need to comply with the regulatory guidelines including the necessary standards for production, marketing, distribution and quality control. APIs also undergo rigorous testing and evaluation.
APIs play a vital role in the production of generic medicines since generic drug manufacturers tend to rely on APIs that do not have a patent or the patent of the API is in the public domain. The APIs can thus be used to produce equivalent versions of branded medicines which are cost-effective.
APIs serve as starting points for future research and development. Pharmaceutical companies tend to explore new APIs to address the unmet medical needs and develop innovative treatments. As the development of novel APIs requires substantial research and development efforts, they are eligible for intellectual property protection. Once a patent is obtained, a pharmaceutical company gets the right to exclusively manufacture and market the APIs for a specified duration.
DU Organics manufactures various API Intermediates which are used in pharmaceutical production. For obtaining more information with respect to the same, visit our website or contact us today.