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Rising healthcare expenditure, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, and increased consumption of generic drugs have created opportunities for API chemical companies, which can provide their expertise to pharmaceutical companies.

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Despite the growing popularity of API biologics, API chemicals remain much in demand. The various manufacturing services for APIs and intermediates offered by contract manufacturing companies range from clinical-stage development to commercial launch.

Finding the top API chemical companies in contract manufacturing

Pharmaceutical Technology has listed the leading API chemical companies in contract manufacturing based on its intel, insights, and decades of experience in the sector. The list includes companies that provide various products and services including, but not limited to:

  • GMP manufacturing
  • Industrial-scale manufacturing of complex molecules
  • Analytical services and regulatory support
  • Manufacturing to support clinical trials, and
  • Tech transfer and scale-up management

The information contained within the download document is intended for pharmaceutical manufacturers, pharmaceutical executives, process engineers, and any other individual involved in API chemical procurement and manufacturing.

The document contains detailed information on the manufacturers and their services, alongside contact details to aid your hiring decision.

Related Buyer’s Guides which cover an extensive range of pharmaceutical equipment manufacturers, solutions providers and technology can also be found here.

Technologies in API chemical manufacturing

API chemical companies are investing in the latest technologies and processes such as lyophilisation, particle engineering, polymorph screening and solid-state chemistry that enable the production of specialised APIs, high-potent APIs (HPAPIs), and intermediates.

The key purification technologies used by chemical companies include catalytic organic synthesis, continuous flow processing, cryogenic chemistry, fermentation, amino acid chemistry, chromatography, fractional crystallisation, solvent extraction, nano-milling, and chiral synthesis.

Moving API production closer to the operating location is one of the trends that is emerging in the sector due to the supply chain constraints created during the COVID-19 pandemic. API chemical companies that have manufacturing facilities closer to pharmaceutical companies are likely to benefit more amid this trend.

Furthermore, the rising energy costs, raw material costs and demand for sustainable practices will require contract manufacturing organisations to demonstrate how they can provide services more efficiently to pharmaceutical companies.

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

Frequently asked questions

  • What are Active Pharmaceutical Ingredients (API) and why are they important?

    Active Pharmaceutical Ingredients (APIs) are the biologically active substances in pharmaceutical drugs responsible for producing therapeutic effects. They are vital to drug formulation, and their quality, purity, and efficacy determine a drug’s overall effectiveness. The production of APIs involves complex chemical and biological processes, including purification, synthesis, and scaling up to meet clinical and commercial demands. APIs must meet stringent regulatory standards to ensure patient safety and the quality of the final drug product.

  • What are the different types of API chemical manufacturing technologies?

    API chemical manufacturing technologies include continuous flow processing, cryogenic chemistry, catalytic organic synthesis, and nano-milling. Each method allows the precise production of specific APIs with varying complexity and purity requirements. For example, cryogenic chemistry is used for temperature-sensitive APIs, while continuous flow processing enables efficient large-scale production. These technologies ensure the consistent quality and scalability of API production, meeting the needs of both clinical and commercial stages of drug development.

  • What role does purification play in API manufacturing?

    Purification is critical in API manufacturing to ensure the removal of impurities, by-products, or contaminants that may arise during synthesis. Techniques such as chromatography, crystallisation, and solvent extraction are used to isolate and purify APIs to meet regulatory and safety standards. High levels of purity are essential, especially in pharmaceuticals targeting diseases where the margin of error is small, such as in cancer treatments. Effective purification leads to APIs that are both safe and effective for patient use.

  • How do contract manufacturing organisations (CMOs) support API production?

    Contract manufacturing organisations (CMOs) offer specialised services, from small-scale API development to large-scale commercial production. They provide expertise in tech transfer, regulatory support, and scale-up management. CMOs help pharmaceutical companies focus on R&D while ensuring API production adheres to Good Manufacturing Practice (GMP) standards. This allows pharmaceutical companies to meet global market demands while maintaining the quality, consistency, and safety of APIs.

  • What trends are shaping the API chemical manufacturing industry?

    Recent trends in API manufacturing include the shift towards sustainable practices, such as green chemistry, and the localisation of supply chains to mitigate disruptions caused by global events like the COVID-19 pandemic. The industry is also seeing increased demand for high-potency APIs (HPAPIs) and the use of advanced technologies like polymorph screening and solid-state chemistry to produce more efficient drugs. Additionally, there is growing attention on reducing environmental impacts and energy consumption in API production.