An active pharmaceutical ingredient (API) is an active component of a specified medicine. Throughout the process of pharmaceutical manufacturing, an API plays a critical role as a medicinal application agent. Each pharmaceutical product contains two core ingredients: inactive excipients that deliver the medicine to a target system and the APIs themselves.
APIs are not to be mistaken as pure, unfiltered drugs. Rather, APIs are major components that must be processed properly to become safe medicine for clinical application. APIs are compounds created through various chemical combinations—not direct raw materials. Read on for further information about API in manufacturing: everything you need to know.
Characteristics of API Production
API manufacturing involves a wide array of complex chemical or biological processes. The synthesis of APIs from raw materials requires multi-step procedures that utilize a variety of high-tech processing technologies. The process involves selecting a compound structure, producing a high quantity of the chosen API, and analyzing the compound for quality control and assurance.
API manufacturers often utilize set standards to determine the strength and size of an API in a specific medication. However, such standards vary from brand to brand due to testing methods and necessary potencies. No matter the scope of strength, quality API production requires a high degree of expertise, efficiency, and concentration.
Everything you need to know about API in manufacturing regards stringent quality regulations. Since the quality of APIs direct correlates to the efficacy of desired results and the safety of medication, poor or compromised APIs are unusable in pharmaceuticals. Staff must correctly perform each step of the process in accordance with Good Manufacturing Practices (GMP) requirements to meet the regulations of the FDA.
GMP API Pharmaceutical Manufacturing Services
The growing demand for advanced APIs is apparent in modern society. State-of-the-art production facilities can provide the products you need for success. For expert and custom API manufacturing services, turn to Moravek. As a contract manufacturing organization, we create radiolabeled APIs suitable for research and clinical trials.
With our scope of experience and knowledge, our team of radiochemists and support staff can easily meet GMP demands and aid your regulatory needs. Contact a Proposal Development Coordinator today to learn more about Moravek Quality and begin designing a custom campaign.