The Ultimate Guide to Choosing Types of Active Pharmaceutical Ingredients

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.

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:

The Active ingredient in a pharmaceutical drug is known as the active pharmaceutical ingredient (API). The active pharmaceutical ingredient(API) provides a biologically active component to a drug product like a tablet, capsule, cream, injectable, etc that produces the intended effects in diagnosing, treating, treating, or preventing diseases.

API produces a desired pharmacological effect and excipients&#; role in the drug development process. Some of the drug products may contain more than one active ingredient. Any drug product mainly comprises the API and the excipients and the combination of API and excipients comprise the final finished formulation of the medicine.

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Pharmaceutical excipients are substances in the drug product/formulated alongside the active ingredient of a medication which is included for the purpose of long-term stabilization to aid the manufacturing process and in handling the active substance concerns such as by facilitating powder flowability or non-stick properties etc.

The selection of suitable and proper excipients depends upon the route of administration and the dosage form and also the active ingredient and other factors. The process for optimizing and composition of the mixtures used in the drug is called Formulation. 

Types of active pharmaceutical ingredients

There are several types of active pharmaceutical ingredients (APIs), which can be broadly classified into the following categories:

• Synthetic APIs: These are chemically synthesized compounds that are produced through various chemical reactions. Examples include aspirin, paracetamol, and many antibiotics.
• Natural APIs: These are active ingredients that are obtained from natural sources such as plants, animals, or microorganisms. Examples include morphine, insulin, and penicillin
• Biologic APIs: These are large, complex molecules that are produced using biotechnology methods such as recombinant DNA technology, gene editing, or cell culture. Examples include monoclonal antibodies, vaccines, and gene therapies
• Highly potent APIs: These are APIs that are used in very small quantities but have very high potency, such as certain hormones or anticancer drugs
• Radiopharmaceutical APIs: These are APIs that contain radioactive isotopes, which are used in nuclear medicine for the diagnosis or treatment of diseases such as cancer
• Combination APIs: These are APIs that combine two or more active ingredients into a single dosage form, such as combination therapies for HIV/AIDS, hypertension, or diabetes

Each type of API has its own unique properties and requires specific manufacturing and quality control processes to ensure its safety and efficacy in pharmaceutical products.

Active pharmaceutical ingredients applications

Active pharmaceutical ingredients (APIs) find application in high-quality drugs that treat many diseases pertaining to oncology, cardiology, CNS and neurology, orthopedics, gastroenterology, nephrology, ophthalmology, endocrinology, and other diseases. APIs can potentially create a more sustainable healthcare system by introducing more innovative products.

The safety and efficacy of the drug have a direct effect on the quality of active ingredients, for this reason, most countries have regulated the active ingredients. The regulation of active ingredients will increase the safety and quality of drugs for consumers and will strengthen the pharmaceutical drug supply system.

The ICH Q7 provides guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs); these guidelines will help to ensure that API meets the quality and purity. APIs are mainly manufactured by chemical synthesis, recovery from natural resources, extraction, cell culture/fermentation (specific guidance for APIs manufactured by cell culture/fermentation), or any combination of these processes.

In the manufacturing of API the key starting material (KSM), raw material, and intermediates are used in the production of API and is incorporated as an essential structural fragment into the structure of the API. API starting material has specified chemical properties and structure details. According to Q7 guidance appropriate GMP is to be applied to those intermediates and /or API manufacturing steps which includes the validation of the critical process steps which determine the quality of the API and also in the manufacturing process which proceeds from early API steps to final steps, purification, and packaging.

As mentioned the below Table, gives guidance on which API starting material is normally introduced into the process.  (Ref table from the Q7 Good manufacturing practice guidance for active pharmaceutical ingredients ( https://www.fda.gov/media//download)

     Type of ManufacturingApplication of this guidance to steps (shown in blue) used in this type of manufacturingChemical ManufacturingProduction of the API starting materialIntroduction of the API starting material into the processProduction of Intermediates(s)Isolation and PurificationPhysical processing, and packagingAPI derived from animal sourcesCollection of organ, fluid, or tissueCutting, mixing, and initial processingIntroduction of the API starting material into the processIsolation and purificationPhysical processing, and packagingAPI extracted from plant sourcesCollection of plantCutting and initial extractions(s)Introduction of the API starting material into the processIsolation and purificationPhysical processing, and packagingHerbal extracts used as APICollection of plantsCutting and initial extraction Further extractionPhysical Processing, and packagingAPI consisting of comminuted or powdered herbsCollection of plants and /or cultivation and harvestingCutting /comminuting  Physical Processing, and packagingBiotechnology: fermentation/cell cultureEstablishment of the master cell bank and working cell bankMaintenance of working cell bankCell culture and /or fermentationIsolation and purificationPhysical processing, and packaging&#;Classical&#; Fermentation to produce an APIEstablishment of the cell bankMaintenance of the cell bankIntroduction of the cells into fermentationIsolation and purificationPhysical processing, and packagingTable: Application of this Guidance to API Manufacturing

FAQs:

What is the difference between an API and Excipient?

Active pharmaceutical ingredients (API) provide a biologically active component of a drug product that produces intended effects in the diagnosis, cure, treatment, or prevention of diseases. Any drug product mainly comprises API and excipients and a combination of API and excipients comprise the final finished formulation of the medicine. API produces a desired pharmacological effect and the role of excipients in the drug development process.

What are excipients in pharmaceuticals?

Excipients are substances in the drug product/formulated alongside the active ingredient of a medication which is included for the purpose of long-term stabilization to aid the manufacturing process. The selection of suitable and proper excipients depends upon the route of administration and the dosage form and also the active ingredient and other factors.

What is the role of the Q7 guideline?

Q7 provides guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs), this guideline will help to ensure that API meets the quality and purity.

What is API in pharmaceuticals?

In the context of the pharmaceutical industry, API stands for Active Pharmaceutical Ingredient. It refers to the biologically active component in a drug product that produces the intended therapeutic effect. APIs can be derived from natural sources or synthesized chemically. They are the key components that make a drug effective in treating a particular disease or medical condition. Once an API is identified, pharmaceutical companies can develop it into a drug product by adding other inactive ingredients, such as excipients, to make it stable, safe, and effective for patients. APIs are subject to strict regulations and quality control measures to ensure their purity, potency, and safety for use in pharmaceutical products. They are also tested extensively to ensure their efficacy and consistency in delivering the intended therapeutic effect.

Reference:

• Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry. , www.fda.gov/media//download.
• &#;ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients Step 5 NOTE for GUIDANCE on GOOD MANUFACTURING PRACTICE for ACTIVE PHARMACEUTICAL INGREDIENTS. , www.ema.europa.eu/en/documents/scientific-guideline/ich-q-7-good-manufacturing-practice-active-pharmaceutical-ingredients-step-5_en.pdf.
• &#;ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients Step 5 NOTE for GUIDANCE on GOOD MANUFACTURING PRACTICE for ACTIVE PHARMACEUTICAL INGREDIENTS. , www.ema.europa.eu/en/documents/scientific-guideline/ich-q-7-good-manufacturing-practice-active-pharmaceutical-ingredients-step-5_en.pdf.
• &#;Office. &#;Q7A Good Manufacturing Practice Guidance.&#; U.S. Food and Drug Administration, , www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients. Accessed 23 Mar. .
• Canada, Health. &#;Active Pharmaceutical Ingredients &#; Good Manufacturing Practices &#; Questions and Answers &#; Canada.ca.&#; Canada.ca, , www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/active-pharmaceutical-ingredients-questions-answers.html. Accessed 23 Mar. .

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