The Chinese Drug Administration initiated a series of campaigns against the irregularities of medicines by birth over a decade ago, tightening the quality norms of medicines to be open, including the quality of the APIs (Active Pharmaceutical Ingredients): the quality and strength of medicines rely on the APIs. APIs are the fundamental components that are responsible for the therapeutic effects in drugs, thus API manufacturing is a crucial part of the pharma manufacturing process. APIs and how they are made teaches us about the complexity and accuracy involved in the making of pharmaceuticals. In this blog, we discuss the API manufacturing process, its stages and the significance of Good Manufacturing Practices (GMP).
What is API Manufacturing?
API manufacturing is the industrial manufacturing of the active biologic component in a drug. This process turns raw chemical substances into high-purity compounds suitable for medicinal formulation. Depending on the specific drug type, these APIs may be bio-based or synthesized chemically.
To ensure that APIs produced are not harmful but effective, regulatory and quality standards followed by pharmaceutical companies, including top pharma companies in India like Chemox Pharma, are quite stringent.
How API is Manufactured: The Manufacturing Process
The typical stages of the production of an API are chemical synthesis, purification, crystallization and final processing. Here’s how it all breaks down:
Raw Material Sourcing
The first step is to obtain good quality raw materials, which are also the basic components of the API. Reagents, solvents, and intermediates are included. It is critical that these materials are consistent and traceable through the ingredient flow.
Either via Chemical Synthesis or Fermentation
It is made by chemical synthesis or biological fermentation, depending on the nature of the API. In chemical synthesis, complex molecules are built through stepwise reactions. Conversely, microbial cultures generate APIs during fermentation, Widely used in antibiotics and other biologically-derived drugs do this.
Purification
Upon synthesis, the API is purified by several purifications stages to remove by-products, impurities, and unreacted raw materials. Common methods employed include crystallization, distillation, and chromatography. Aim for a pure and potent API that will be suitable for formulation.
Crystallization and Isolation
Examples include crystallization that can influence physical properties of the API, including particle size and solubility, which are to be correlated with drug performance in the final dosage form. Filtration, drying, and product collection directly follows crystallization in order to yield the solid API in its final state.
Milling and Micronization
To improve bioavailability and guarantee consistent mixing with excipients, the dried active pharmaceutical ingredient (API) can be milled or micronized to obtain the preferred particle size.
Final Quality Testing
Every step of the way, and most certainly at the finish line, the API is rigorously tested for purity, identity, potency and stability. It can only progress to formulation phase after passing all tests.
Importance of GMP in Active Pharmaceutical Ingredient (API) Manufacturing
GMP API stands for Good Manufacturing Practices API — a regulatory framework by the likes of US FDA, EMA, WHO, etc. These practices guarantee consistent production and control of APIs according to quality standards.
But to mention some fundamentals of GMP during API manufacturing:
- Cleanroom environments to ensure cleanliness
- Routine calibration and maintenance of equipment
- Traceability and detailed batch records
Full documentation of all processes and procedures (SOPs)
Skilled and trained personnel
When pharmaceutical manufacturers in India such as Chemox Pharma strictly follows GMP, they will be able to manufacture APIs that are in line with international standards, and serve domestic as well as international markets.
How India Became a Leader in API Manufacturing
India is now a worldwide leader in producing active pharmaceutical ingredients (APIs) because of its cheap production capacities and workforce, including compliance with standards. World renown quality suppliers of APIs (Active Pharmaceutical Ingredient) companies examples include Chemox Pharma that supplies Atorvastatin Calcium, Emtricitabine, Sildenafil Citrate and many more to people all over the world.
Over the last few years, initiatives like “Make In India” and PLI (Production Linked Incentive) schemes have strongly advocated for reducing dependency on imports through enhanced domestic API production. This makes India one of the most favorable countries for API sourcing.
Conclusion
API manufacturing is a complex, regulated, and specialized field that requires technical skills and quality controls at every stage. Specialized processes, from raw material selection through testing final APIs, are an essential part of ensuring the safety and efficacy of any pharmaceutical product.
Chemox Pharma – The leading API manufacturers in India Chemox Pharma is the one of the API manufacturers in India who commit for utmost excellence in the API manufacturing and development. We offer industry-leading APIs that bolster the healthcare sector around the world, thanks to our innovation-oriented approach and our commitment to GMP regulations.
