Active Pharmaceutical Ingredients and Intermediates

28 Oct.,2024

 

Active Pharmaceutical Ingredients and Intermediates

Active pharmaceutical ingredients (APIs) are the active components in a pharmaceutical drug that produce the required effect on the body to treat a condition. APIs are produced by processing chemical compounds. In a biologic drug, the active ingredient is known as a bulk process intermediate (BPI).

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Despite high manufacturing expenses, strict regulatory policies, and policies in controlling drug prices in many countries, attractive opportunities have emerged in the API market due to growing cases of chronic diseases, including diabetes, asthma and cancer.

The information provided in the download document is drafted for pharmaceutical executives, research and development (R&D) executives, quality control and quality assurance executives, as well as API manufacturers, distributors, suppliers, sales managers, process engineers, technicians, research associates and production chemists, and any other individuals involved in the operations of the API and active pharmaceutical intermediates industry.

The download contains detailed information on API manufacturers to aid in purchasing decisions, including product ranges and contact details.

Related Buyer's Guides which cover an extensive range of pharmaceutical technologies, equipment, and manufacturers, can also be found here.

Types of active pharmaceutical ingredients

APIs are broadly categorised into two types ' synthetic and natural. Synthetic APIs are further classified into innovative and generic synthetic APIs, based on the type of synthesis used.

Synthetic chemical APIs, also known as small molecules, constitute a large part of the pharmaceutical market, with many small molecule drugs commercially available in the market.

Natural APIs are used in making biologics, which are increasingly becoming the top-selling drugs in the market. Despite the growing demand, biologics are currently significantly fewer in number compared to small molecule drugs.

Based on the solubility, APIs are categorised into insoluble and soluble drugs.

Top active pharmaceutical ingredients and intermediates suppliers

Pharmaceutical Technology has listed the leading suppliers of active pharmaceutical ingredients and intermediates based on its intel, insights and decades-long experience in the sector. The list includes companies that can develop and supply high-quality pharmaceutical materials, including, but not limited to:

  • Fine chemicals and intermediates, such as high-docosahexaenoic acid oil for API production
  • APIs for central nervous system therapies
  • Natural cannabinoid (CBD) ingredients, CBD isolates and cannabis distillates
  • Excipients
  • Insulin for cell culture media
  • Ammonium compounds
  • Mineral salts

The list also includes suppliers of mixing and drying technologies, polymer coatings for drug delivery, extraction technologies for high-purity APIs, and dispersion and wet milling technology. Providers of automatic capsule filling machines, dry powder and liquid-based material handling systems, analytic services for biological assays, pharma tablet manufacturing machines, and custom synthesis services are detailed in the document as well.

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FAQs

What are active pharmaceutical ingredients (APIs)?

Active pharmaceutical ingredients (APIs) are the biologically active components of drugs responsible for producing the desired therapeutic effect. APIs can be synthetic, produced through chemical processes, or derived from natural sources such as plants or animals. The API is combined with other substances, known as excipients, to create the final pharmaceutical product.

What are the main types of APIs?

APIs are divided into two primary categories: synthetic and natural. Synthetic APIs, which include small molecule drugs, dominate the pharmaceutical market. Natural APIs are used in biologics, such as vaccines and cell therapies, but remain fewer in number.

How are APIs classified based on solubility?

APIs are classified into soluble and insoluble drugs. Soluble APIs dissolve in bodily fluids, aiding absorption, while insoluble APIs require specialised formulations to ensure effective delivery and absorption within the body.

Who uses API buyer's guides?

The guide is used by pharmaceutical executives, R&D teams, quality control experts, and API manufacturers. It provides valuable insights into API suppliers, product ranges, and contact information, helping users make informed purchasing decisions.

What opportunities exist in the API market?

Despite challenges such as high manufacturing costs and regulatory hurdles, the API market continues to grow, driven by the rising prevalence of chronic diseases like diabetes, asthma, and cancer. This growth is further fuelled by increasing demand for biologics and advanced therapeutics.

For full details (including contact details) on the leading companies within this space, download the free Buyer's Guide below:

Pharma Intermediates and Fine Chemicals: An Explainer

In the pharmaceutical industry, the production of complex drugs often requires the use of specialized chemicals known as pharma intermediates and fine chemicals. These substances play a crucial role in the synthesis and manufacturing processes, enabling the creation of high-quality pharmaceutical products. Let's look at pharma intermediates and fine chemicals and their significance in the pharmaceutical sector. 

Understanding Pharma Intermediates and Fine Chemicals  

Pharma intermediates are chemical compounds used as building blocks in the synthesis of active pharmaceutical ingredients (APIs). They undergo further chemical reactions to form the desired APIs. On the other hand, fine chemicals are high-quality, pure chemical substances that possess specific properties and are used as key components in drug formulation and manufacturing processes. 

Importance of Pharma Intermediates and Fine Chemicals

  • Drive innovation and development of new drugs. 
  • Ensure high-quality and purity of pharmaceutical products. 
  • Enable the synthesis of complex APIs with specific properties. 

Benefits of Pharma Intermediates and Fine Chemicals  

  • Efficiency: Pharma intermediates and fine chemicals simplify the complex synthesis processes by serving as intermediate steps. 
  • Purity and Quality: Fine chemicals are produced with high purity, ensuring the final pharmaceutical products meet stringent quality standards. 
  • Customizability: The properties of these chemicals can be tailored to meet specific drug requirements. 
  • Cost-effectiveness: By optimizing production processes, pharma intermediates and fine chemicals contribute to cost reductions in drug manufacturing. 

Examples of Pharma Intermediates and Fine Chemicals  

Examples of pharma intermediates include acetic acid, benzene, ethanol, and various functional groups such as amines, carboxylic acids, and halides. Fine chemicals encompass a broad range of substances, including solvents, reagents, catalysts, and chiral intermediates, among others. These chemicals serve as key components in the production of antibiotics, cardiovascular drugs, analgesics, antiviral agents, and more. 

Use Cases of Pharma Intermediates and Fine Chemicals  

  • API Synthesis: Pharma intermediates play a vital role in the synthesis of APIs, contributing to the creation of diverse pharmaceutical products. 
  • Drug Formulation: Fine chemicals are utilized in drug formulation to enhance stability, solubility, and bioavailability, ensuring effective delivery and patient compliance. 
  • Process Optimization: Pharma intermediates and fine chemicals aid in optimizing manufacturing processes, improving efficiency, reducing waste, and increasing yield. 
  • Quality Control: Fine chemicals are used as reference standards and analytical reagents for quality control purposes, ensuring the purity and consistency of pharmaceutical products. 
  • Customized Drug Development: The customizability of pharma intermediates and fine chemicals allows pharmaceutical companies to develop innovative drugs tailored to specific therapeutic requirements. 
  • Research and Development: These chemicals support drug discovery and development efforts by providing essential building blocks and enabling the synthesis of novel compounds. 

Conclusion 

Pharma intermediates and fine chemicals form the backbone of pharmaceutical manufacturing, facilitating the synthesis, formulation, and quality control of a wide range of medications. Their efficient utilization enhances production processes, ensures product purity and quality, and enables customized drug development. By supporting research and development endeavors, these chemicals contribute to advancements in the pharmaceutical industry, ultimately benefiting patients worldwide with safer, more effective, and innovative medicines. 

Zenfold Sustainable Technologies produces chemicals without increasing the Carbon footprint. Through green and eco-friendly manufacturing practices, Zenfold ensures sustainability.

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