Role of Active Pharmaceutical Ingredients in the Healthcare Industry

Published On: November 2022

Drugs and medicines are made from different compositions that cure illness and improve the patient’s health. There lies a substance and ingredient that takes charge of being an active pharmaceutical ingredient in treating and diagnosing the disease in the body of both humans and animals. This actual substance in the medication for healing the ailment is called API (Active pharmaceutical ingredient). For example, API, or the main ingredient in Aspirin, is a substance called Acetylsalicylic acid, and to cure fever, the API used is paracetamol. The drug market has significantly progressed in its field, where the central growth area is in the active pharmaceutical ingredient market that is evolved on a huge scale. The global API market is estimated to surpass around USD 53.8 billion by 2030, registering a CAGR of 9.59% from 2022 to 2030.

Why not just API in a Pill?

The fact is that, without the active substance in a medication, an illness cannot be cured, but it is also true that to make a pill, more substances named excipient are added to give it flavor, color, and volume. An excipient is an inactive ingredient that is used while preparing the drug that is used to bind all the ingredients together.

Hence, just as a fist is done by clenching all our fingers inwards against the palm, a pharmaceutical drug is made when API contributes as a key ingredient, and other additions perform as a curing agent.

The excipient role is essential in drug formulation as these excipients adjust and modify the product or the final drug characteristics.

API permission

For a manufacturer of a Pharma company, the company must get approval from the country of the end user where the quality and safety standards are purely approved before the medicine comes into the market. The capsules sold in the United States must be FDA-approved (Food and Drug Administration). European Medicine Agency will evaluate and supervise the medicines for European markets. The companies are then given a certificate of approval by the government, and permission is granted. Moreover, at times during the audit of the company, other than factory inspection, every batch of API is inspected for its approval. If there is any issue in the audits, the company is disallowed to manufacture and supply the capsules in the industry.

Challenges in the API Industry

The margins in the pharmaceutical industry are a good deal, but at the same time, it is a sensitive market. The correct formulation of medicines ensures the safety of the person. Even a minutely poorly manufactured API can cause serious health issues to the end user, and the manufacturer's licensing can be put on hold.

  • Complete hygiene unit - The unit must operate per the standards prescribed by the FDA. Since pharmaceuticals involve the safety and health of the patients, complete hygiene had to be adhered to run the manufacturing unit.

  • Raw material and finished product handling - The raw material and the finished pill must not meet moisture, extreme weather conditions, or any unknown outside particle like hair, nail, or dust, else the attributes of the product change, and the medicine could cause damage to the patient.

  • R&D for API - A good research team must be hired to research and develop new APIs for curing and eradicating different ailments that come into existence these days with a sedentary lifestyle and bad eating habits. During the COVID-19 pandemic, there was a sudden demand for API, and all pharma companies were putting their best foot forward to research and get an effective API for the virus.

  • Not all APIs are a hit - APIs had to go through a process where the side effects had to be minimal, the dosage frequency must be clarified, and water solvent, stability, and sensitivity to temperatures tests were performed beforehand. Not all developed APIs can sustain all these tests and are not commercialized.

  • Quality checks before dispatch – Stability, and safety for the person consuming the medicine is the most necessary motto of any pharma company. An unexpected discrepancy can occur in any unit, but before the final dispatch, a thorough cross-check is essential to ensure their medicine is safe to consume.

Hence, several companies and countries look out for outsourcing to lower the cost of industrial production, quantity and quality issues, and benchmark sustainability in the market. Here, their APIs are usually in a powdered form, and they are sold in considerable quantities to the drug companies procuring them.

A huge quantity of API is imported from countries that are producers of the main active ingredient. This helps save extra costs on infrastructure, processing, and labor equipment essential to manufacturing it. Companies are improvising their techniques and strategies to cope with the rising demand for diseases and provide medical aid to patients and relieve them from illness.