API in Manufacturing: Everything You Need To Know (2024)

FAQs

What is API in manufacturing? ›

The active ingredient in a pharmaceutical drug is called an active pharmaceutical ingredient (API). An example of an API is the acetaminophen contained in a pain relief tablet. The active ingredient in a biological drug is called a bulk process intermediate (BPI).

1. Introduction. 1.1 Objective. This document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.

Key Starting Material (KSM): A raw material, intermediate or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API.

In general, the API Process Development and Production involve a number of processing processes, including reaction, crystallization, separation and purification, filter cake washing, solvent swapping, and solvent exchange.

In 2021, 53% of the $85.6 billion in APIs used in U.S.-consumed medicines were produced in the United States. More than 85% were produced in either the United States (53%) or Europe (33%) China produced only 7%

API integrations are software components that automatically update data between clients and servers. Some examples of API integrations are when automatic data sync to the cloud from your phone image gallery, or the time and date automatically sync on your laptop when you travel to another time zone.

API refers to the key ingredient or chemical that makes the drug work. While a finished formulation or a formulation intermediate is the process in which different chemicals including the active ingredients are mixed in specific ratios to produce a specific drug.

Both APIs and pharmaceutical intermediates are an integral part of the pharma sector, but they serve different roles with unique characteristics. APIs represent the active ingredients responsible for therapeutic effects, whereas intermediates are intermediary compounds synthesized during the production of APIs.

APIs, or application programming interfaces, act as the language that allows different software applications to talk to one another. Imagine you're ordering a coffee at a cafe; the API is like the waiter who takes your order to the barista and then brings your coffee to you.

What is API key for beginners? ›

An application programming interface (API) key is a code used to identify and authenticate an application or user. API keys are available through platforms, such as a white-labeled internal marketplace. They also act as a unique identifier and provide a secret token for authentication purposes.

Developing and producing Active Pharmaceutical Ingredients (APIs) includes various processing steps, such as reaction, crystallization, separation and purification, filter cake washing, solvent swap, and solvent exchange.

API-First Development is an approach that emphasizes the creation of APIs at the beginning of the development process. It focuses on consistency, reusability, and quality to ensure broad adoption, ease of integration, and compatibility with diverse systems.

Generally speaking, however, an API call follows three basic steps: The API client initiates the API call, or request for information. The API client must format the request according to the protocol and schema provided by the API endpoint. The API endpoint receives the request.

API in Manufacturing: Everything You Need To Know. 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.

Effective supply chain management relies on connected infrastructure, logistics, and business ecosystems. And an application programming interface (API) is the glue that connects them all.

API inventory is a complete list or collection of all the APIs used across your organization or software solution. It's a crucial part of API compliance and governance that helps identify every API used in your software and related information, such as its use, limitations, users, and security profile.

Contract API Manufacturing refers to the outsourcing of the production of Active Pharmaceutical Ingredients (APIs) – the components in medicines that produce the intended effects – to a third-party organization.