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.

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.

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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:

An overview of the Intermediates manufacturing category for pharmaceutical procurement teams. This guide provides you with the overall market size and trends, key drivers, opportunities and challenges, contract manufacturers in the category and advice on how to improve strategic supplier partnerships. 

Definition

Intermediates refer to chemical compounds that are used as building blocks or precursor materials in the synthesis of active pharmaceutical ingredients (APIs) or finished pharmaceutical products.

These intermediates play a crucial role in the pharmaceutical industry by enabling the efficient and cost-effective production of drugs.

Pharmaceutical intermediates can include various organic and inorganic compounds, such as reagents, catalysts, chiral compounds, and other functional groups, which are utilised at different stages of the drug manufacturing process.

Pharmaceutical intermediates serve as a critical link between the discovery of new drug candidates and the commercial production of pharmaceutical products. They allow for the synthesis of complex molecules and provide the necessary chemical transformations to convert raw materials into active drugs.

Pharmaceutical intermediates contribute to enhancing drug efficacy, stability, and bioavailability, thereby ensuring the quality and effectiveness of medications. These intermediates also play a vital role in achieving regulatory compliance by meeting the stringent standards set by regulatory authorities.

Market Size and Trends

The global pharmaceutical intermediates market was valued at USD 29 billion in and is expected to grow to over USD 52.6 billion by , at a CAGR of 6.3% from to .

This growth can be attributed to several factors, including the increasing demand for generic drugs, the rising prevalence of chronic diseases, and the expansion of pharmaceutical manufacturing activities in emerging markets.

The market growth is also driven by advancements in drug development and the need for efficient and cost-effective production processes. Pharmaceutical intermediates play a crucial role in the synthesis of active pharmaceutical ingredients (APIs) and the manufacturing of finished pharmaceutical products. These intermediates serve as building blocks and precursor materials, enabling the transformation of raw materials into complex molecules required for drug production.

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