Producing life-saving drugs is a critical process that involves the use of both intermediates and APIs. If you are new to the pharma world, you may have heard these two terms and used them interchangeably. While both of them are crucial for drug development, they have critical differences that you must understand. In this blog, we will discuss everything about API vs Intermediate. We will understand the role of APIs and intermediates and their differences.
What is an API for pharma?
An API, or Active Pharmaceutical Ingredients, is responsible for the drug’s therapeutic effect. These active compounds can be sourced naturally or synthesized using chemicals. For example, Tigecycline API is used in anti-bacterial medicines, and Mirabegron API is used for urinary disorder treatment. Even a small amount of API has a significant impact; therefore, the final drug contains only a small concentration of API.
APIs are critical in developing medicines. As a result, the API manufacturing process follows a strict regulatory framework to ensure quality and effectiveness. When sourcing APIs for drug manufacturing, ensure that the API manufacturer follows the necessary regulations because each country has unique standards.
What is Intermediate for pharma?
Intermediates are the critical raw materials used by pharmaceutical companies to produce APIs. Intermediates are often produced as the by-product of the API synthesis process. They are crucial in the chemical reaction that creates the API’s structure. For example, 4-aminophenol is an intermediate used in the synthesis of paracetamol. These intermediates are cost-effective and essential for API production.
Although there is no strict regulatory framework for intermediate production, high-quality intermediaries can help you create better APIs. So, choose a reliable intermediate supplier for your API or drug production process.
API vs Intermediate: What’s the difference?
Let’s understand the difference between API and intermediate.
The function
The APIs are the final component that creates the drug’s therapeutic effect. APIs take effect once consumed to neutralize the harmful antigens. The bulk intermediates are precursors for API production. They are the building blocks essential to creating stable, effective APIs.
The usage
The APIs are combined with excipients to develop the final, effective drug for treating the patients. The intermediates are used in the chemical synthesis of the APIs to achieve the desired structure and have the desired therapeutic effect.
Therapeutic value
The APIs have a direct therapeutic effect after the patients consume the drugs. The bulk intermediates have no therapeutic value and can’t be consumed directly. However, they are essential to creating the therapeutic APIs.
The regulatory compliance
The production process of APIs must meet strict GMP regulations, and the quality must align with international pharmacopoeia standards such as USP, EP, IP, BP, etc. The regulations for the production and quality of the intermediates are less stringent. However, its quality affects the API, so choosing high-quality intermediates is essential for better APIs.
Why choose Chemox for the best API and intermediates?
Chemox Pharma is one of the top intermediate and API manufacturers in India. We have been creating high-quality and budget-friendly APIs and intermediates manufacturers in our state-of-the-art WHO-GMP-certified R&D and manufacturing facility in Dahej, Gujarat.
Since our establishment, our team has worked diligently to create diverse APIs, intermediates, and files for DMFs. To date, we have developed 18 APIs that meet international standards.
The following are a few reasons customers across 20+ countries have trusted us:
- WHO-GMP approved API manufacturing process for both APIs & intermediates.
- Customized the APIs & intermediates to meet your desired pharmacopoeia standards.
- A diversified portfolio of 18 APIs, including antibacterial, antihistamines, erectile dysfunction, and more.
- Customized packaging solution as per your needs.
- Reliable supply chain for fast and secure delivery across the globe.
- Clear and transparent business policies.
- Our dedication to CSR activities includes reducing carbon emissions, supporting green initiatives, and developing rural areas.
Contact us now with your queries and our team will reach out immediately!
Conclusion
If you are new to the pharma world, you may be confused about the difference between APIs and intermediates. While both are essential in developing a drug, their role and effects differ. The key difference between API and intermediate is their function, therapeutic value, and regulatory compliance. APIs get their therapeutic impact from the synthesis using the intermediates. The intermediates are by-products of the API production process and are precursors for creating stable, effective APIs. The API manufacturing process needs to follow strict rules, while there are relatively relaxed regulations for intermediates. Contact Chemox Pharma for high-quality APIs and intermediates at competitive prices!
FAQ
What’s the difference between APIs and intermediaries?
The APIs and Intermediates differ based on their role in drug production and their effect. Intermediates are the chemical compounds essential in the synthesis of the APIs. APIs have the therapeutic effect of the drugs. The API quality must meet the strict regulatory standards. There is no strict regulatory compliance needed for intermediates.
What is the API manufacturing process?
The API production process begins with acquiring high-qualtiy intermediates. Through chemical synthesis of the intermediates, you get the API compounds. These compounds need to be purified and crystallized to develop a stable API for use in drugs. The manufacturing and quality assurance process must follow the international standards.
How do you find a reliable API manufacturer in India?
When looking for an API manufacturer in India, focus on their experience, expertise, and regulatory compliance. Ask whether they follow the international production standards and ensure they have relevant certificates. Look for the customer reviews and their manufacturing capacities. Chemox Pharma is one of India’s most trusted API and intermediate manufacturers with WHO-GMP certified facilities, creating custom pharma products per customers’ needs. Contact us for more information.
Why are intermediates important?
Intermediates are the building blocks for APIs. Low-quality intermediates will affect the quality and therapeutic effect of the APIs. Therefore, you must choose high-quality intermediates to create effective APIs and reduce the cost of production.
