An active pharma ingredients /pharmaceutical ingredients (APIs), also commonly known as a drug substance, is the active ingredient of a biologically active drug or pesticide. The similar term “pharmaceutical active ingredient” is used in medicine, and the term “active substance” can be used to refer to natural products. active pharma ingredients are the active ingredients contained in drugs, and active pharma ingredients are parts of drugs that are needed in medicine to provide the intended therapeutic effect.

active pharma ingredients (APIs) are chemical complexes that are primarily produced in countries such as the United States, Europe, China, and India. APIs have pharmacological activity and are primarily used in combination with other ingredients to diagnose, treat, mitigate, and cure diseases. However, in recent years, many pharmaceutical companies have begun to import these substances into their countries from active ingredient producing countries.

Modern medicines are used by people to prevent, treat, diagnose and cure diseases. All medicines consist of two main ingredients. So, the main ingredient, the active pharma ingredients, is the chemically and biologically active substance that acts in the body, and the tablet contains other ingredients known as excipients, such as lactose and mineral oil. It is chemically inert and has, for example, volume, sweetness and color. These excipients help deliver the API into the body.

To produce APIs, multiple compounds and raw materials are used in multi-step reactions. However, their main goal is to directly treat diseases by acting together with a combination of inactive forms (due to pharmacological activity). Consequently, the production of these APIs contributes to the release of chemicals into the environment, leading to increased pollution.

The medicine contains only the required amount of API, since less amount of API is needed to achieve the effect. Some drugs contain multiple APIs to treat different diseases, and active pharmaceutical ingredients (APIs) are the most important raw materials used to manufacture drugs.


What is an active pharma ingredients/active pharmaceutical ingredients?

Active Pharmaceutical Ingredients (APIs) are natural or synthetic chemical-based active compounds commonly found in therapeutic or veterinary drugs. There are chemical-based active compounds that are produced by unsafe chemical methods. Therefore, their widespread production, use and disposal pose a danger to humans, water bodies (including drinking water) and other biological life due to uncontrolled contact with the environment .

In addition, over the last decade, the presence of these compounds has been detected in groundwater, drinking water and wastewater at trace levels ranging from nanograms to micrograms .The recent discovery of the prevalence of huge quantities (5600 ng/L) of about 18 APIs in Lake Victoria, Uganda has been reported . This has made these active pharma ingredients global polluters. The formation of these compounds does not occur from a single reaction source, but from many chemical components, usually starting from a single intermediate compound.

In addition, the process of converting raw materials into APIs produces several intermediate products. Some of these reactions typically undergo long purification routes, requiring the use of huge reactors during development. At the same time, these Active Pharmaceutical Ingredients (APIs)  are tested for purity before being sold to pharmaceutical companies.

Contents of the drug

All medications contain two subcomponents.

Pharma active ingredients

Excipients – are chemically inert substances that help deliver the API into the system. For example, lactose, mineral oil, etc.

Intermediates are chemicals that are in the process of converting raw materials into APIs. In some cases, many intermediate products may be produced before the final API is produced.

Prequalification of active pharma ingredients (APIs)

Prequalification of active pharmaceutical ingredients (APIs) is an independent procedure that identifies APIs that are of good quality and manufactured in compliance with WHO Good Manufacturing Practices (GMP). If a prequalified API is used in the manufacture of a finished pharmaceutical product (FPP) for which prequalification is sought, prequalification of that FPP is greatly facilitated.

Active pharma ingredients prequalification should not be confused with the API master file procedure (APIMF). Under this procedure an API manufacturer is invited to provide its APIMF in support of an application for prequalification of an FPP.

In order to become prequalified an active pharmaceutical ingredient (API) must be of good quality and manufactured in accordance with WHO Good Manufacturing Practices (GMP). Evaluation of an API for prequalification has two components: assessment of the API master file (APIMF) to verify compliance with WHO norms and standards, and verification that the site(s) of API manufacture comply with WHO GMP requirements.

Prequalification of an API is made with specific reference to the manufacturing details and quality controls described in the APIMF submitted for assessment. A prequalified API is therefore clearly identifiable with a specific APIMF version. An APIMF version may be altered during prequalification assessment, or as a result of post-prequalification changes. Therefore, the version number of the current APIMF is included on the WHO List of Prequalified active pharma ingredients, to serve as a reference for the production and quality control of that API.

As well having their prequalified active pharma ingredients included in the WHO List of Prequalified active pharma ingredients, successful applicants receive a WHO Confirmation of active pharma ingredients Prequalification for each API for which they attain prequalification. This contains information regarding the accepted active ingredient specifications, and the assay and related substances test methods. It may be provided by the applicant to interested parties.

GMP Guidance for Active Pharmaceutical Ingredients

About Pharmaguidanaces Channel

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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