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What is an API?
Th4 . 25, 2024
The safety and efficacy of a drug depend on the quality of its API. Poorly manufactured or unsafe APIs may result in harmful consequences, including death. Therefore, they are required to be regulated. APIs must adhere to strict safety and quality standards set by the manufacturing country. Even if the manufacturing is outsourced, APIs must follow the stringent rules of the concerned health authority. For example, if the API is manufactured in Korea or Japan for distribution in the US, it will still be inspected under the FDA guidelines.
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WHAT ARE APIS?
Th4 . 25, 2024
While the number of available prescription or over-the-counter drugs (OTC) under different names increases daily, the situation differs in the case of APIs. Considering how expensive the steps to introducing a new drug to the market are, there isn’t a great number of new APIs being introduced. An API is sold under only one name: the nonproprietary name.To avoid confusion in this market, which potentially would have dangerous consequences, WHO, in cooperation with national drug safety agencies worldwide, came up with a list of non-proprietary names back in 1953. The organization revises the list regularly, and you can send them a request for new International Nonproprietary Names (INN).So, everywhere in the world, Ramipril is sold as Ramipril, and that API can’t be bought under any other name. Drug manufacturers can sell their drugs under any name they want, but they must put the API name right under the brand name.
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Active pharmaceutical ingredient (API - Part II)
Th4 . 25, 2024
an extracted and purified active component of the cannabis plant (for example a cannabinoid)an extract of specified parts of the cannabis planta trituration of specified parts of the cannabis plantthe dried flower of the cannabis plant separated from leaves and stemThe term 'API starting material' refers to the starting material from which the API is made, not to the API.The manufacture of the API is required to be in compliance with Part II of the PIC/S Guide to GMP, as well as the relevant parts of the Annexes to the PIC/S Guide to GMP.
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What are Active Pharmaceutical Ingredients (APIs) & Excipients?
Th4 . 25, 2024
API production is a highly sophisticated, technically demanding process and which is accomplished by chemical synthesis or biochemical methods. Active pharmaceutical ingredients are first obtained in the crude state. Subsequent production operations convert the crude material to the final API that meets the pharmacopoeial and/or similar requirements. Pharmaceutical manufacturing occurs in two general steps. First, raw materials are converted into Active Pharmaceutical Ingredients (APIs). The second step in pharmaceutical manufacturing is the final formulation of the drugs. Final formulations of API employs three major types of processes: organic chemical synthesis, fermentation and biological and natural extraction.
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What are Active Pharmaceutical Ingredients (APIs)?
Th4 . 25, 2024
Another aspect of cGMP compliance is the documentation of batch production records and manufacturing processes. Records are essential for pharmaceutical manufacturing sites as they provide detailed information about production performance and product quality. Automated systems streamline these processes by taking over documentation tasks. Single Use Support provides comprehensive drug substance management solutions, encompassing filling and primary packaging, as well as protective solutions for single-use bags and platform systems for freezing and thawing. Our goal is to offer drug substance manufacturers maximum flexibility, efficiency, and safety throughout the production process.
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What Is an Active Pharmaceutical Ingredient (API)?
Th4 . 25, 2024
Active Pharmaceutical Ingredients i.e., API refers to an active ingredient that is contained in the medication. For instance, the active ingredient for relieving pain is incorporated in the painkiller. It is called API. Even its small amount has a powerful impact, so only a mere part of this active ingredient is contained in the medicine. Moreover, you will find its amount and name contained in the medication on the OTC (over-the-counter) drugs’ package.
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API Pharmaceutical:What is API in Pharma, Difference between API & Formulation
Th4 . 25, 2024
Pharma is a big industry. However, the value chain can be broadly divided into two categories: API and finished formulation. API makes up a part of the drug that enables the latter to produce the desired effect. China is one of the leading suppliers of API. In 2020, when the pandemic started and severely disrupted the supply chain in China, the pharma industry was affected for the time being due to the shortage of raw materials.
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What is an Active Pharmaceutical Ingredient?
Th4 . 25, 2024
Therapeutics, in its broadest definition, is the use of interventions aimed at alleviating the effects of disease in humans or animals.The constitutive substances that elicit therapeutic effects are known by different names, including active, active pharmaceutical ingredient, active principle, drug substance, medicinal agents or therapeutic substance.This article provides a comprehensive definition of active pharmaceutical ingredients and as well as answers to common FAQs.
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Active pharmaceutical ingredients and intermediates for the pharmaceutical industry
Th4 . 25, 2024
Despite high manufacturing expenses, strict regulatory policies, and policies in controlling drug prices in many countries, attractive opportunities have emerged in the API market due to growing cases of chronic diseases, including diabetes, asthma and cancer.The information provided in the download document is drafted for pharmaceutical executives, research and development (R&D) executives, quality control and quality assurance executives, as well as API manufacturers, distributors, suppliers, sales managers, process engineers, technicians, research associates and production chemists, and any other individuals involved in the operations of the API and active pharmaceutical intermediates industry.
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