What is Active Pharmaceutical Ingredient and why is it essential for drug manufacturing? (2024)

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The COVID-19 pandemic caused a panic among global pharmaceutical manufacturers as the supply of APIs was disrupted from China, the world’s largest producer

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What is Active Pharmaceutical Ingredient and why is it essential for drug manufacturing? (1)

Active Pharmaceutical Ingredients or APIs are essential to the pharma industry. According to pharmaceutical company Biocon, an API means “the biologically active component of a drug product (tablet, capsule, cream, injectable) that produces the intended effects”.

It is one of the two main ingredients in medicines, the other being excipients. APIs are crucial to the manufacture of drugs. The COVID-19 pandemic caused a panic among global pharmaceutical manufacturers as the supply of APIs was disrupted from China, the world’s largest producer.

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Since then, the world has been worried about overdependence on China as far as manufacturing of APIs is concerned. So, here is a handy explainer on what APIs do and why they are vital to the pharma industries:

What do APIs do? API is the biologically active component that makes sure a drug works. It is different from excipients, a chemically inactive substance which actually delivers the effect of API.

API manufacturers first acquire relevant raw materials. The compounds go through a host of processes before they become APIs. After rigorous quality control checks, these ingredients are then supplied to pharmaceutical manufacturers who use it to make medicines.

Importance: APIs are vital to the pharma companies. The COVID-19 pandemic made the world realise how easily global supply chains could be disrupted. The lockdown in China and the resulting supply shocks forced many countries to reckon with their pharmaceutical supply chains.

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India, which is already the world’s third-largest producer of pharmaceuticals by volume, was among them. According to a 2020 article in The Conversation, the country relied on China for about 70 percent of its supply of APIs. For some well-known drugs such as ibuprofen, amoxicillin and paracetamol, the country was almost fully dependent on China for API supply.

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The government has made efforts to cut back on its reliance on China and promote domestic API production. The Centre had announced Rs. 15,000 crore performance-linked incentives scheme for pharmaceutical companies.

According to a PTI report from March this year, 35 APIs which were imported earlier, are being manufactured in India under the Centre’s production linked scheme for the pharma company.

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Furthermore, the government has given ‘in-principle’ approval to set up three bulk drug parks, one each in Gujarat, Andhra Pradesh and Himachal Pradesh.

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What is Active Pharmaceutical Ingredient and why is it essential for drug manufacturing? (2)

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What is Active Pharmaceutical Ingredient and why is it essential for drug manufacturing? (2024)

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What is Active Pharmaceutical Ingredient and why is it essential for drug manufacturing? ›

What Is an Active Pharmaceutical Ingredient (API)? An active pharmaceutical ingredient (API) is the component of an over-the-counter (OTC) or prescription medication that produces its intended health effects. If a prescription drug has a generic, its name is the same as its API.

What is an active pharmaceutical ingredient? ›

The main ingredient in a medicine that causes the desired effect of the medicine. Some medicines contain more than one active pharmaceutical ingredient that act in different ways in the body. Also called API, drug substance, and pharmacologic substance.

What is the purpose of active ingredient of a drug? ›

Active ingredients are the chemical compounds in medicines that have an effect on the body. Essentially, they are the ingredients within your medicine that make the medicine work. A 'brand name' is the name given to a medicine by the company that makes it.

Why is it important that the ingredients used in medicines are pure? ›

The availability of impurities can completely alter a formulation and make it something else entirely because chemicals react differently. For example, the wrong chemical components in a drug formulation can make a drug dangerous to human beings.

What is the role of ingredients in pharmaceutical industry? ›

At the heart of every successful drug is its Active Pharmaceutical Ingredient (API) - the component responsible for delivering the intended health effect. The distribution of APIs plays a pivotal role in the pharmaceutical supply chain, ensuring the accessibility, quality, and safety of these essential ingredients.

What is an example of an active ingredient in a pharmaceutical preparation? ›

Examples of Active Pharmaceutical Ingredients
Active Ingredients in Common OTC Medications
Brand NameActive Pharmaceutical Ingredient
Benadryldiphenhydramine
Claritinloratadine
Mucinexguaifenesin
5 more rows
Jul 28, 2023

What is the process of manufacturing active pharmaceutical ingredients? ›

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.

Why are active ingredients important? ›

Active ingredients are used in skincare products to address various skin concerns and issues such as dry or oily skin, eczema-prone skin, or to help reduce the appearance of fine lines and wrinkles.

What are active ingredients and purpose? ›

Active ingredients are key components in skincare products that perform specific functions to improve the skin's appearance, texture, and overall health. Their purpose is to target specific skin concerns, such as anti-ageing for mature skin, nourishing for dry skin, moisturizing for normal skin, etc.

What is the function of active ingredients? ›

The United States Food and Drug Administration defines an active ingredient as “any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.” In skin care, ...

Why are ingredients important? ›

The use of fresh, high-quality ingredients can enhance the flavor profile of the dish, making it more enjoyable for consumers. Moreover, it can help to ensure that the food produced is packed with essential nutrients, reducing the risk of foodborne illnesses and ultimately increasing customer satisfaction.

Why is it important to know the active ingredient in the OTC? ›

This is the easiest way to prevent errors and overdoses, because OTC medicines are often used without health professional advice. All over-the-counter (OTC) medication labels contain Drug Facts. Drug Facts include important information about the active ingredient(s), uses, warnings, doses, and directions.

Why are pharmaceutical drugs important? ›

They are essential for the prevention and treatment of diseases, and protection of public health. The use of ineffective, poor quality, harmful medicines can lead to therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death.

What are the chemicals used in pharmaceutical manufacturing? ›

The most common chemicals used in the pharmaceutical industry. Some of the most common chemicals used in the pharmaceutical industry include acetone, hydrochloric acid, acetic anhydride, benzyl chloride, and diethyl ether. These may either be used as active ingredients, solvents, precursors, or reagents.

What must a pharmaceutical formulation contain? ›

Benefits and constraints of the active pharmaceutical ingredients (APIs), valuable excipients, associated interactions, and manufacturing procedure are the four basic components for a successful pharmaceutical formulation. The formulation often functions in a way that includes different dosage forms.

What are the roles of good manufacturing practices in pharmaceutical industry? ›

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

What is the difference between a drug substance and an active pharmaceutical ingredient? ›

A drug substance, also known as an active pharmaceutical ingredient (API), is the specific chemical compound or molecule within a drug product that provides the intended therapeutic effect. It is the active ingredient responsible for the drug's pharmacological activity.

What are pharmaceutical active compounds examples? ›

Pharmaceutical active compounds (PhACs) are one of the EPs of major concern. The main source of the PhACs are the effluents dispensed from wastewater treatment plants due to the the continuous entrance of the ECs to the aquatic systems. The PhACs include antibiotics, tranquilizers, diuretics, and psychiatric drugs.

What is a pharmacies active ingredient? ›

The active ingredient is the chemical that makes the medicine work. Companies may need to add other things when they make the medicine: to fill the product if the amount of active ingredient is very small. to keep the active ingredient from changing so it can work for longer.

Is ibuprofen an API? ›

Ibuprofen is a type of NSAIDs

These pharmaceutical APIs are available in various formulations, including tablets, capsules, creams, and gels, making them convenient for different administration routes. Some popular examples of NSAIDs include aspirin, ibuprofen, naproxen, and diclofenac.

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