The quality of a drug depends on the procedure and accurate measurements. However, what affects the drug’s efficacy the most is the API. In this blog, we will discuss the role of APIs in the pharmaceutical industry and provide a breakdown of the API manufacturing process.
What is an API in pharma industry?
Drugs are made with two components: The API and excipients. API stands for Active Pharmaceutical Ingredient; it is the core component responsible for the therapeutic effect of the drug. The Excipients are the non-active ingredients used in drug development to make it stable and safe for consumption. Therefore, effective drug development requires high-quality APIs that meet regulatory standards.
Importance of API in pharma industry
The following are a few crucial roles of API in pharma industry:
Affects the efficacy of the drug
As discussed above, the API is the core of a drug. Therefore, even the slightest irregularities in the purity and structure of the API directly affect the efficacy of the drug. A high-quality API ensures that the drug has a stable structure and bioavailability.
Maintain the quality and safety of the drug
If the drug contains impurities or is contaminated, it can cause a toxic reaction and harm to patients. Therefore, your API should have consistent quality to ensure that each batch of drug meets efficacy and safety standards.
When selecting an API supplier, consider a company whose active pharmaceutical ingredient manufacturing facility adheres to international GMP (Good Manufacturing Practices) standards.
Regulatory adherence
Each drug must comply with the regulations of the authority of the country in which it intends to operate. Therefore, when your APIs meet the regulatory standards, you will get approvals effortlessly. Thus, you should choose an API supplier, such as Chemox Pharma, that can help customize the API pharmacopoeia standards to meet your specific needs.
Empowers innovation in the pharma industry
API development is the foundation for creating new-generation molecules and targeted therapy drugs for specialized treatments. Therefore, APIs are crucial in the pharmaceutical industry.
Active pharmaceutical ingredient manufacturing process
Let’s look at how the pharma companies like Chemox Pharma create high-quality API:
Sourcing raw material
The first step of creating a high-quality API is finding pure raw materials. The purity of the Reagents, Solvents, and Intermediates used in creating the API affects the safety and performance of the API.
Chemical synthesis or Fermentation
These raw materials are converted into API compounds using chemical reactions, precise temperature control, catalysts, and optimized reaction conditions. There are two ways for compound formation:
- Chemical synthesis: A controlled chemical reaction is conducted to make small-molecule drugs.
- Fermentation: Microbial cultures are developed to create antibiotics and other biologically derived drugs.
Purification
These compounds are purified to create pure and potent API for drug formulation. Distillation, chromatography, recrystallization, and filtration are a few techniques used to remove by-products, solvents, and impurities.
Crystallization and Isolation
Once purified, the APIs are crystallized to achieve the desired form, size, and stability. Once isolated, these crystals are further processed for safe packaging and shipping.
Milling and Micronization
The API crystals are then converted into smaller particle sizes in the milling and micronization process. This process is crucial to improve the bioavailability and dissolution of the API with excipients for drug formation.
Final Quality Testing
Before the API is shipped to the pharma companies, it undergoes rigorous testing to ensure that it meets the desired standards. A few things that must be tested in the API quality check are residual solvents, impurity profiling, stability, and contamination.
To create effective APIs, one needs to set up quality control at each step of the production process. Therefore, you need a reliable API manufacturer who adheres to regulatory standards and develops high-quality pharma products.
Where can you find a high-quality API in India?
Chemox Pharma is a trusted API manufacturer in India. We are also one of the top api intermediate manufacturers in India, known for our WHO-GMP certified facilities. We work with the best scientists to develop efficient intermediates and APIs at an affordable price. Our state-of-the-art facility includes production plants, an R&D department, and a pilot project.
Under the Make In India schemes, we are actively producing APIs such as Atorvastatin Calcium, Emtricitabine, Sildenafil Citrate and many more. We can help you customize your API order based on IH, BP, USP, IP, and EP. Contact us for consultation.
Conclusion
API in the pharma industry are crucial because they affect the efficacy and stability of the drug. The API formulation is crucial for maintaining the quality of the drug and fostering innovation in the pharmaceutical industry. The API manufacturing company must adhere to regulatory standards to create effective medicines. Chemox Pharma is one of the most trusted API and intermediate manufacturers in India. We can help you customize the APIs based on your pharmacopoeia needs. Contact us to know more.
FAQ
What is the role of API in the pharmaceutical industry?
API are the core component responsible for the therapeutic effect of the medicine. The following are a few critical roles of API in pharma industry:
- To determine the efficacy and potency of the drug
- To create a stable medicine
- To create drugs that adhere to the regulatory standards
What happens when API quality is compromised?
When the API quality is compromised:
- It can affect the efficacy and absorption of the drug
- The drug can become toxic
- The API becomes unstable
- The regulatory requirements are not met
Therefore, choose an API manufacturer that adheres to strict guidelines to maintain the quality of the pharma products.
What’s the difference between API and Intermediate in pharma?
APIs are the active ingredients used in drug formulation. On the other hand, Intermediates are the building blocks of API. The intermediates can reduce the number of steps in the API formation process without affecting the quality of the final pharmaceutical product. API manufacturers must adhere to strict regulatory guidelines. However, the API intermediate manufacturers have relatively relaxed regulatory guidelines.
How to choose the right API manufacturing company in India? API in pharma
When choosing an API manufacturing company in India, check if they have:
- GMP certificate from a reputable authority
- Fully-equipped R&D and production facility
- DMF for their pharma products
- Ability to manage large-scale production
- Experience with the global market
