Medicines are an important part of our lives now. Whether it’s a common flu or a fatal disease, there are advanced medicines that make our healthcare system stronger. Active pharmaceutical ingredients (APIs) are essential for these drugs to be useful. So, let’s understand the API meaning in pharma and its importance in medicine development.
What is API in the pharma industry?
A medicine or drug is made of two broad ingredients: active pharmaceutical ingredient (API) and excipients (non-therapeutic elements for drug stability and absorption).
An Active Pharmaceutical Ingredient (API) is the core component of a medicine that produces the intended therapeutic effect in the body. As shown in the image, a finished drug is created by combining the API with excipients such as binders, fillers, and stabilizers, which is important for drug absorption and stability. The excipients don’t provide any medical effect themselves. Through the drug formulation process, the API and excipients are carefully blended and processed to produce the final dosage form, such as a tablet or capsule, ensuring the medicine is safe, effective, and has consistent quality for patient use.
The role of API in drugs is to provide the therapeutic effect/ relief from the symptoms. They are the biological components that make a drug effective for treating, preventing, or managing a disease.
The APIs can be categorized broadly into two categories as follows:
- Synthetic APIs are made from chemical synthesis.
- Biological APIs (Natural) are derived from living organisms like mammalian cells, microbes, or yeast.
In recent years, India has shifted its focus to developing the essential APIs to reduce the medical reliance on other countries. India is currently the third-largest producer of API by volume (source). We are creating affordable and compliant APIs to export them worldwide.
The importance of APIs in medication
APIs are essential to make medicines more effective. But the role of API in drugs is more than that. Let’s explore the importance of API in medication development.
Impact on the therapeutic effect of the medication
The API is the core element of the medication.
The Active Pharmaceutical Ingredient is responsible for the drug’s:
- Interaction with your body
- Mechanism of action
- Potency to cure or control the disease
If the API doesn’t meet the quality standards or is contaminated, the drug won’t be medically effective. In the worst-case scenario, it can be toxic to the body, leading to unwanted side effects.
Ensure the safety of the drug
APIs are biologically active components, affecting the efficacy and impact of the drug. Therefore, its purity and stability are essential to create a safe drug. The impurities and contamination of the API can lead to adverse side effects, drug toxicity, and decreased effectiveness. It ultimately affects the patient’s health.
Therefore, the API manufacturers need to ensure that each batch has consistent quality measures. Every API manufacturer needs to follow strict Good Manufacturing Practice (GMP) standards to assure the quality and safety of their API products. In addition to the local GMP standards, following the GMP guidelines of global authorities like the WHO or the US FDA makes the manufacturer more reliable.
Reliable manufacturers, like Chemox Pharma, adhere to strict GMP guidelines to create a safe process to develop APIs with consistent quality.
Regulatory compliance of the drug
Every drug must meet the regulatory standards to be sold in a particular market. Therefore, if your APIs don’t meet the quality standards, your drug will also fail.
The regulatory authorities check the process and ingredients used in creating a drug. The API regulatory compliance guidelines are focused on:
- API manufacturing processes
- Purity profiles
- Stability data
- Impurity limits
- Batch consistency
- GMP compliance of the manufacturing facility and development team
If you are focused on drug development only, you need a reliable API manufacturer who can offer compliant APIs. It ensures that your drugs are compliant and can easily enter a new market.
Price of the final drug
The cost of the API is one of the major factors in the price of the drug. With domestic, large-scale production of APIs, the cost of the drugs can be significantly reduced. This makes useful drugs affordable for people. When you choose a reliable API supplier, you can expect affordable active pharmaceutical ingredients without any compromise on quality.
Create high-quality drugs with custom APIs from Chemox Pharma
Chemox Pharma is a trusted API manufacturer with WHO-GMP certification. Our manufacturing facility in Dahej, India, is equipped with state-of-the-art technology and a highly skilled team to create quality APIs.
To date, we have created 19 APIs, including categories such as Anti-Bacterial, Cardiovascular, Anti-Fungal, Anti-Asthmatic, Anti-Histamines, Topical Beta Blockers, and more. Due to our regulatory compliance, we have been able to export to 20+ countries. You can customize the quality of the APIs based on your pharmacopeia needs. Contact us to know more.
Conclusion
An Active Pharmaceutical Ingredient (API) is a biologically active compound responsible for the therapeutic effect of the drugs. They are mixed with excipients to create a consumable drug commercially available in the market. They affect the efficacy, safety, and price of the drug. High-quality and regulatory-compliant APIs make it easier for the drug to be approved in the new market. Therefore, you should choose a reliable API manufacturer like Chemox Pharma. We have a WHO-GMP-certified facility to create essential APIs. Contact us to know how we can help you create an API based on your requirements.
FAQ
What’s the role of API in drugs?
The following are a few roles of API in the drugs:
- It is responsible for the therapeutic effect
- It affects the potency of the drug
- It ensures that the drug is safe and meets the dosage needs
- Make the drug comply with the regulatory body of any market
What are the differences between synthetic and biologic APIs?
The synthetic APIs are derived from controlled chemical reactions, while the biologic APIs are derived from living organisms. These APIs are more easily scalable, stable, and cost-effective. The Biologic API is developed using cell culture, fermentation, or recombinant DNA technology.
What’s the difference between API and Excipients in drug formulation?
The Active Pharmaceutical Ingredients (APIs) are the key components of the medicine, while the Excipients are the supporting ones. The API is responsible for the therapeutic effect of the drug. The excipients bind the API with other components to make it consumable and stable. They both are essential to create a good medicine.
Who is the best API manufacturer in India?
Chemox Pharma is a highly reliable Indian API maker that has built its reputation over time by being strict with quality. We have been following WHO-GMP guidelines to produce effective APIs. You can decide the quality and standards of the medicines according to your pharmacopoeia requirements, and we will help you. Moreover, we can provide packaging that is customized according to your specifications to guarantee safe delivery to you. Feel free to reach out to us for more information.
How to choose the right API manufacturer in India?
The following are a few factors to consider when choosing an API manufacturer in India:
- Regulatory compliance
- Transparency with certificates and technical documents
- Adherence to GMP standards
- Reliable supply chain for timely delivery
- Reliability of quality control
