The Indian API market is growing at a tremendous rate, making us the third-largest supplier in the global market. However, the fundamental pillar of this rising growth is the manufacturing and supply of pharmaceutical intermediates. The intermediates in pharma are the main building blocks of creating any therapeutic medicine. Let’s understand what pharmaceutical intermediates are and their uses, and also discuss the difference between APIs and Intermediates!
What are pharmaceutical intermediates?
Pharmaceutical intermediates are essential chemicals used in creating medicines. They are critical in manufacturing the therapeutic APIs.
Think of pharmaceutical intermediates as parts of a machine; without these parts, your machine wouldn’t be assembled. These intermediate chemicals undergo chemical processes to synthesize the APIs used to create the final drug. Therefore, to create a high-quality API, you’ll require high-quality pharmaceutical intermediates.
Intermediates in pharma can be classified in various ways. They are primarily based on the final drug or the usage of the intermediate chemical. For example, there are intermediates for antibiotics, analgesics, and other compounds. Often, the intermediates are categorized based on whether they are non-GMP or GMP.
India’s pharmaceutical intermediate market is expected to reach USD 2,781.1 million in 2025 and is expected to grow at a 7.2% CAGR till 2035 (source). The easy access to resources, workforce, and labor reduces the cost of manufacturing. Therefore, India offers affordable APIs and intermediates to the global market.
What is the use of intermediates in Pharma?
The bulk drug intermediates are the building blocks of the pharma industry. The following are a few crucial uses of pharmaceutical intermediates:
- Developing therapeutic API: Diverse types of intermediate chemical compounds are used to develop therapeutic APIs.
- Drug formation: The intermediates in pharma are used to improve the stability, solubility, and bioavailability of the drug and boost its effectiveness. The intermediates can be used to create generic and branded drugs.
- Support R&D: Pharmaceutical intermediates are an essential part of the R&D process for developing or improving an existing drug.
API vs Intermediate: What’s the difference?
API and Intermediates are essential for creating effective drugs. However, both of them have different roles and properties. Many people confuse the roles of these two in the drug manufacturing process. Therefore, the following are a few differences between APIs and intermediates in pharma.
Function
- The intermediates are the chemical compounds used in the synthesis process.
- The API has therapeutic effects obtained from the synthesis process.
Usage
- The pharma intermediates are used to develop effective APIs.
- The APIs are used in drug formulation for direct consumption.
Chemical structure
- The Intermediates are chemical compounds that require further processing to create effective drugs.
- The APIs have a therapeutic effect and are thus ready for final drug formulation.
Regulatory compliance
- Intermediate manufacturing doesn’t require any strict regulatory compliance.
- API manufacturing requires strict adherence to regulatory standards.
While no strict regulatory compliance is required for intermediates, it is essential to maintain their quality, as it directly impacts the quality of the APIs. That’s where we can help you!
Chemox Pharma: A trusted manufacturer of pharmaceutical intermediates!
Chemox Pharma is one of the most trusted manufacturers of pharmaceutical intermediates in India and exports its product globally. We focus on creating high-quality intermediates and APIs in our WHO-GMP-certified state-of-the-art facility in Dahej, Gujarat.
We have successfully created 18 APIs using our intermediates and exported them to 20+ countries. Our customers trust us for our commitment to delivering affordable and high-quality pharma products to meet global standards. We can develop customized intermediates and APIs with custom packaging. Contact us to know more.
Conclusion
Pharmaceutical intermediates are critical for creating effective APIs. Therefore, it is essential to understand the role of intermediates in developing life-saving drugs. The intermediates in pharma are chemical compounds synthesized to create APIs. There is no strict regulatory control on the intermediate development in pharma. However, the quality of the intermediates affects the API; thus, it is essential to use high-quality bulk drug intermediates. Chemox Pharma offers premium pharmaceutical intermediates following the WHO-GMP. We can develop custom pharma products (including the packaging) to meet your needs. Contact us to know more!
FAQ
What are bulk drug intermediates, and why are they important?
The bulk drug intermediates, or pharmaceutical intermediates, are chemical compounds used in the synthesis process for API development. They are essential to creating the therapeutic effect of the APIs. High-quality intermediates in pharma boost the stability, solubility, and bioavailability of the APIs. The quality of the intermediate is essential for the purity, yield, and performance of the drug.
What’s the difference between API and Pharmaceutical intermediates?
The primary difference between API and pharmaceutical intermediates is their effect and usage. The intermediate is a chemical compound that acts as the building block for creating APIs. APIs have therapeutic properties essential to developing the final drug. An Intermediate has no therapeutic effect and cannot be used directly in the drug formulation process.
What is the size of the Indian pharmaceutical intermediate market?
The Indian intermediate market is expected to reach USD 5,587.7 million by 2035. The growth is projected based on India’s role as the third-largest supplier of APIs globally. The availability of resources and labor makes production easier and more affordable. Additionally, government initiatives such as Make In India and the PLI Schemes boost local production. More intermediate manufacturers are seeking international regulatory certifications to expand in global markets, creating a promising future for the intermediate market in India.
Do bulk drug intermediates need regulatory approval?
The intermediate manufacturers are not subject to strict regulations. However, the key to creating effective APIs and high-quality final drugs is the quality of the intermediates, which is critical. Chemox Pharma is one of the most trusted intermediate and API manufacturers in India with WHO-GMP standards. We can help you create a custom pharma product based on your needs. Contact us now to know more or get a quote!
