API Raw Material: The Complete FAQ Guide In 2024

1.What Is Meant By API?

API with capsules- Picture Courtesy: iStock

In pharmacy, API is a short term for Active Pharmaceutical Ingredient which refers to the active part of any drug. APIs are of various type, however, they are obtained from the API raw material.

As drug consists of active ingredients and excipients the former work as the main agent for relieving pain or showing desired therapeutic effect. In this way, we may say that API is the vital part of medicines wether tablets, pills, capsules, syrups, or ointments to produce intended health effects.

2.Define API Raw Material?

API raw material with pills & capsules- Picture Courtesy: vereskpolpharmed.com

API raw material is the unprocessed form of active pharmaceutical ingredients. It simply means that they are neither thoroughly processed nor exposed to heat, air, or water therefore available in original form. Such material is obtained from plants, herbs, and fruits etc.

These API raw material is inevitable for making active pharmaceutical ingredients in different kinds of drugs. The quality, strength, and purity of API raw material greatly affect the finished drug product. Hence, it must be handled properly to avoid environmental effects and enhance the essence.

3.What Is The Role Of API Raw Material In Pharmaceutical Industry?

API raw material with tablets- Picture Courtesy: iStock

API raw material is considered paramount in pharmaceutical industry that revolves around the production and processing of various drugs on large scale. There are few such prominent reasons that demonstrate how crucial is the use of API raw material. These are as follows:

Firstly, all kinds of medications whether solid dosage like tablets and capsules or liquid dosage like suspension and emulsions are made by adding active pharmaceutical ingredients which are derived from API raw material.

Secondly, quality control is a major step to be carried out in this sector. That's why, manufacturers want to gather raw material, so, they can process it keeping in view the standards and regulations for retaining drug quality.

Lastly, pharmaceuticals manufacturing is an extensive field thereby requiring bulk API raw material which is both reliable and cost-effective.

4.How Does The Quality Of API Raw Material Influence Pharmaceutical Manufacturing?

Capsules with powder- Picture Courtesy: iStock

API raw material is the building block for pharmaceutical drugs which means the final product is dependent upon the quality of its components. Similarly, if the quality of these raw material is poor it will ultimately affect the quality of produced drug in negative way. The result will be adulteration, ineffectiveness, and risk of contamination in the finished medication.

Contrary to that, using good quality API raw material can have potential positive effects on drug. It can enhance the efficacy, stability, and shelf life of medicines. Hence, the patient will feel more safe to consume the dosage, which leads to customer trust building and help in global reach for your business.

5.What Are The Sources Of API Raw Material?

There are various sources of API raw material. Almost all these sources are natural, however, in some cases raw material is synthesized through chemical processes or in laboratories. Some of the notable sources include:

Plant Sources

Plant sources for drugs- Picture Courtesy: bankofafrica.biz

Plants are said to be the most important and convenient source of API raw material across the globe. Active pharmaceutical ingredients are derived from plants through different processes like extraction, drying, and crushing etc. The common examples of plant sources for API raw material include leaves, seeds, roots, herbs, and fruits etc.

Animal Sources

Different animals in forest- Picture Courtesy: onegreenplanet.org

You may wonder how animals can be the source for generating API raw material but actually it is. In fact, since history most of the drugs made for acute diseases often have their origin from animal sources. Today, we can also see medical practitioners using insects, snakes, animal parts and their secretions for drugs manufacturing. Thus, they are essential source of active pharmaceutical ingredients.

Microorganism Sources

Microorganisms in water- Picture Courtesy: ecosoft.com

In addition to plants and animal sources, the use of microorganisms for deriving API raw material is also prevalent in medical industry. These microorganisms are essential to produce antifungal properties against microbial growth. Hence, it is another significant source to be used for drugs like antibiotics.

6.Classify API Raw Material On The Basis Of Therapeutic Effect?

Drugs testing- Picture Courtesy: mankindpharma.com

Well, API raw material market is such an extensive that you are bound to understand its classification or it will definitely make you puzzle. It is pretty simple. The purpose of this classification is to categorize API raw material, so, one can get the basic idea about each class, their significance, and what could be their potential effects. So, let's begin!

No	Category	Description
1	Cardiovascular APIs	Cardiovascular APIs give high quality ingredients which are beneficial in treating heart related problems like hypertension, angina, and heart failure. These are helpful to advance cardiovascular therapies.
2	Central Nervous System APIs	Such APIs are utilized for curing disorders related to brain, spinal cord, and nerves. Similarly, the drug made by using Central nervous system APIs is effective for treatment.
3	Respiratory APIs	As the title illustrates, respiratory APIs are particularly used to make drugs for alleviating respiratory problems such as asthma, tuberculosis, lung cancer, and cystic fibrosis etc.
4	Dermatology APIs	Dermatology APIs are specifically utilized to treat skin related issues like acne, rashes, and fungal infection. Hence, topical creams, ointments, and gels etc., are made by using these APIs
5	Anti infective APIs	Anti infective APIs are the vital category of API raw material which is widely used in making drugs for ending various infectious diseases. Thus, you may find it in treatment for urinary tract infection, kidney or other parts of body.
6	Immunology APIs	Immune system works as an army against bacteria in our bodies. Thus, immunology APIs are used to supplement and strengthen its growth against diseases, fatigue, and immunodeficiency disorders.
7	Hormonal APIs	Hormonal APIs is another significant class which is made part of the pharmaceuticals that helps in restoring hormonal balance and eradicate certain endocrine illnesses.
8	Analgesic APIs	Analgesic APIs refer to active pharmaceutical ingredients which are used to relieve pain of different types. It includes both non-opioid and opioid analgesics.
9	Oncology APIs	Oncology APIs are essential pharmaceutical ingredients which are be used for treating various types of cancer. These are active substances which are crucial to kill cancer cells and obstruct its growth in body.
10	Gastrointestinal APIs	Gastrointestinal APIs are utilized in making drugs for curing related diseases including acid-related disorder, inflammatory bowel diseases, and gastrointestinal motility problem etc.
11	Ophthalmic APIs	Such ingredients are necessary for treating eye health related issues. They are used in making drugs to cure cataracts, eye infections, glaucoma, and near-sighted corrective surgery etc.

7.Differentiate Between API Raw Material And Excipients Raw Material?

Every medication form is composed of two components which are called API raw material and excipients raw material. These ingredients are considered as two sides of the same coin. However, both different from one another in the core of their aspects. That's why, we have highlighted differences between them for your understanding:

No	Aspects	API Raw Material	Excipients Raw Material
1	Definition	API raw material is the active part of drug which is responsible for treating desired disease.	Excipient raw material refers to the inactive ingredients of a drug for the safe and effective delivery of active ingredients.
2	Function	The function of API raw material is to show desired therapeutic effect.	On the other hand, its purpose is to make the drug stable.
3	Number of raw material	Usually, single API raw material is used for making specific drug.	In contrast, multiple excipients raw materials are used for pharmaceutical making such as lubricants, stabilizers, diluents, and colorants.
4	Use	Its use is compulsory for in every drug.	While as, in some cases excipients raw material may not be inevitable for drug delivery as like in case of herbal powder or homeopathic remedies.
5	Picture	Active pharmaceutical ingredient with capsule- Picture Courtesy: istockphoto.com	Various excipients- Picture Courtesy: pharmadigests.com

8.What Are The Uses Of API Raw Material?

API raw material are used in every sector which is engaged in manufacturing any kind of drug. Some of the prominent applications of API raw material are as follows:

Pharmaceutical Industry

Solid dosage form- Picture Courtesy: actylis.com

Pharmaceutical industry is one of the top beneficiary of API raw material for manufacturing of drugs like tablets, capsules, syrups, and emulsions etc. The sector uses bulk of API raw material in order to treat diseases while maintaining their quality and essence.

Nutraceutical Industry

Nutraceutical medication presentation idea- Picture Courtesy: iStock

Similar to pharmaceuticals, nutraceuticals also require API raw material for making pills and protein powder etc. As most of the drugs under this industry is made for enhancing the intake of vitamins, minerals, and nutrients, API like immunology APIs are popularly utilized.

Herbal Industry

Herbal powder capsules- Picture Courtesy: iStock

Since ancient times, herbal treatment is commonly practiced around the globe for treating various disorders. Interesting thing is that today we also found the significance of herbal byproducts. This is the uplifting of drugs due to innovative technology. Thus, API raw material can be better used in herbal industry for drug manufacturing. The common examples include ginkgo biloba and ginseng etc

Veterinary Industry

Veterinary doctor checking dog heartbeat- Picture Courtesy: petprofessional.com

In addition to humans, animals are also in need of proper treatment when get I'll or affected by any disease. In this way, now multiple forms of drugs can be seen being used for animals. These drugs are made in veterinary industry with the help of API raw material.

Dermatology Industry

Beauty capsules- Picture Courtesy: iStock

Skin treatment for enhancing external beauty, removing acne, dark circles, and keratin treatment for healthy hair is prevalent in today's era. All these tactics somehow involve the use of therapeutic agents which are made by using API raw material. Thus, we may say that dermatology and cosmetic industry do use these active ingredients.

9.What Are The Quality Standards For API Raw Material?

FDA quality certification for drugs- Picture Courtesy: investopedia.com

While API raw material is necessary for manufacturing drugs, it is subjected to stringent regulatory requirements. Adherence to the established rules means the concerned API raw material is produced in a safe environment.

It is because information about each step including its properties, how it is synthesized and how its quality is maintained throughout manufacturing process is of key importance. Thus, several quality standards are there to check the API raw material quality which include the USA Food and Drugs Administration (FDA), European Medicines Agency (EMA), and International Organization for Standardization (ISO).

10.Factors To Consider When Selecting API Raw Material For Pharmaceutical Manufacturing?

Whenever you intend to purchase API raw material for pharmaceutical manufacturing on industrial level, make sure to consider some of the important factors. These include:

Quality

Pharmacist examining quality of tablets- Picture Courtesy: Shutterstock

Don't forget to check the quality of API raw material you want to buy. Because poor quality can result in the degradation of your final product. Thus, choose for good quality raw material and must check the quality compliance.

Purity

Purity of the API raw material is also very important to examine because polluted or uncleaned material can cause great delays in cleaning and it may contaminate your drugs.

Authenticity

Pharmacist checking capsule ingredients- Picture Courtesy: iStock

What is the origin of API raw material? Knowing this can help you trace how old are the desired material so you will be able to use them accordingly in your manufacturing.

Cost-effectiveness

You will find many suppliers of API raw material in market but you should look into their prices thoroughly. It is because most of the time, there is a big difference in price but not in quality. So, do check its cost-effectiveness.

Conclusion

To wrap up this guide about API raw material, we are glad to have communicated necessary information on much needed topic. The importance of ingredients in drug manufacturing cannot be denied especially in pharmaceutical industry. However, it brings along with it certain responsibilities regarding quality and sources. So, we hope you have got the desired information which will definitely help you in your business. If you are eager to learn more or want to purchase machines for drug manufacturing Allpack is there to show you latest equipment. You can simply contact us through our website!