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Role of Intermediates in Drug Development

The discovery and development of drugs is one of the most important translational activities in science which contribute to human health and wellbeing. Pharmaceutical companies use drug intermediates for the research and development process. They are the compounds which are taken as building blocks for the production of bulk drugs used by biopharmaceutical companies for R&D purposes. Intermediates can or cannot be separated from drugs. They are hygienically formulated products using high grade raw materials. There are three types of drug intermediates: Pharmaceutical intermediate, veterinary drug intermediate and bulk intermediates. Apart from their types on the basis of their use they are further divided on the basis of advancement into advanced intermediate and active pharmaceutical ingredients (APIs). APIs are compounds that can be safely administered in the human body for therapeutic diagnosis after ample research. They are active ingredients which are later converted into various forms such as suspensions, capsules, tablets and other formulations. On the other hand, the advanced intermediates are the ones with advanced characteristics. Advanced intermediate drugs are used to perform drug interaction activity that has resulted from the formation of new chemical products. Few examples of drug intermediates are capecitabine, lenalidomide, imatinib, gemcitabine, afatinib, ibrutinib, pemetrexed, nilotinib, pazopanib, and temozolamide intermediates. The pharmacological activity of certain drugs is dependent on the reactive intermediates which will modify critical amino acid residues of proteins more importantly enzymes ultimately affect their mode of action. Hence the notion that reactive intermediates are inherently dangerous is unjustified. When a reactive intermediate is necessary for the desired pharmacological effect of a drug, the selectivity it displays towards the target protein is crucial, as off-target binding may produce unwanted toxicities but they don’t produce hazardous toxicities

The global market for reactive intermediates is on the rise because of the rapid growth in research and development activities globally. This market can be divided into chemical industry, pharmaceutical industry and biotechnology. On the industry level the intermediates are divided into premium quality intermediates, high quality intermediates and moderate quality intermediates and among them only premium and high-quality intermediates are majorly used for R&D activities.
The global market for drug intermediates has seen an increase in demand due to the rapidly growing biotechnology and life sciences sectors, as well as rising adoption and application of drug intermediates in research fields. Pharmaceutical and biotechnology companies, as well as research organisations worldwide, have increased their focus on R&D in drug discovery and development. New methods and technologies in drug intermediate equipment, as well as manufacturers offering numerous customizations in the synthesised drugs, have broadened the scope of applications and increased demand for drug intermediate in the global market.

Active pharmaceutical ingredients and intermediates

Pharmaceutical Technology has listed the leading suppliers of active pharmaceutical ingredients and intermediates based on its insights and decades-long experience in the sector. Companies on the list include, but are not limited to, those that can develop and supply high-quality pharmaceutical materials, such as:

  • 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

Process considerations for API development

Solvent System

The solvent system in which an active pharmaceutical ingredient (API) is crystallised influences impurity purging, solvation propensity, growth, crystal morphology, nucleation kinetics, solubility, and polymorph control. Early stages of development are recognised as ideal for identifying benefits and issues with solvent use.

Process Safety

Most large pharmaceutical companies conduct process safety assessments to ensure that the thermal hazards associated with reagents, chemicals, and reactions are understood. Process safety assessments are critical components of active pharmaceutical ingredient (API) development throughout its life cycle, from discovery to commercialization.

Chemical Compatibility Studies

Physical and chemical excipient compatibility with the API is an important consideration during preformulation to ensure that the excipients used do not hamper drug stability and safety.


As a prospective drug candidate progresses from the discovery lead optimization stage through preclinical and clinical development, there are many short-term cost of goods (CoG) factors that need to be taken into consideration. CoG estimates are a valuable tool for developing active pharmaceutical ingredients (APIs), therefore serving as a critical and strategic need during the early stages of development.

Environment Friendly

R&D chemists are now expected to use environmentally friendly green chemistry routes to produce active pharmaceutical ingredients (APIs). High-yielding processes should ideally be developed so that byproducts are not polluting or can be treated to eliminate pollution.

All over the globe Asia Pacific leads the drug intermediate market due to the growth in pharmaceutical and life sciences industry in this region, specifically the emerging markets in India and China. Second comes Europe as a leading market for drug intermediates because of the development and expansion of drug related technologies. The Asia Pacific drug intermediate market is also anticipated to expand at an increasing rate owing to increasing healthcare spending, due to change in lifestyle to western adoption of western lifestyle, and growth in research and development. Asia Pacific is the fastest growing region for the drug intermediate market as several players have invested in the development and manufacturing of drug intermediates. These factors are expected to drive the market growth of drug intermediates during the forecast period. Hence the role of reactive intermediates cannot be ruled out in the field of pharmaceutical industry.

Bioelsa offers a wide range of the finest quality APIs and intermediates to the life sciences and drug discovery communities around the globe.

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