API Manufacture

What does the API manufacturing industry include?

The active pharmaceutical ingredient (API) industry supplies pharmaceutical manufacturers with raw materials for subsequent processing and formulation into saleable pharmaceutical products. Pharmaceutical drugs (drug products) are typically composed of two main component types: an active ingredient, which is either chemically active or has biological activity, and excipients, which are substances included in the product formulation that stabilise the active ingredient and render it to be more manageable and that are usually inert. Other components may be present to render stability, solubility, or other favourable properties. 

Legislation in API manufacturing

The intermediate manufacturers and the pharmaceutical industry share the same governing bodies, the Food and Drug Administration (FDA) in the US, the Medicine and Healthcare Product Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) and therefore follow a similar review and approval pathway. The availability of documentation, such as Active Substance Master Files (ASMF) and Certificates of Suitability (COS), is reviewed favourably by pharmaceutical legislators and help secure Marketing Authorisations based around the specific API supplier. Given the commercial sensitivity around the manufacture, testing, and control of many APIs, suppliers are permitted to file all “restricted” (closed) information directly with the regulatory agencies and allow pharmaceutical manufacturers to cross-reference (via a letter of access) when filing the “unrestricted” (open) part of the file.

Woodley BioReg have expert-level knowledge and understanding of the complex legislation associated with fine chemical manufacture trading in Europe and the US, which includes:

  • Active Substance Master File (ASMF) or Drug Master File (DMF)
  • A Certification of Suitability to the European Pharmacopoeia monographs (CEP) or Certificate of Suitability (COS)

These documents contain details of the raw materials used, production process, formulation, batch release, testing, and further information. API manufacturers must also be compliant with good manufacturing practice (cGMP).

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Recent Trends in the API Manufacturing industry

Recent trends in the API industry include a move for larger pharmaceutical manufacturers to increasingly outsource elements of their supply chains, including ingredients manufacture, to more cost-effective suppliers. These suppliers have typically been in China and India which has resulted in a rapid growth in production capability of APIs.

Many of the “emerging market” API manufacturers and suppliers face the challenge of understanding the complex legislative landscape of the EU, UK and US which includes interpreting the requirements and liaising with the relevant boards of health to secure and maintain the correct regulatory accreditation and compliance.

Examples of specific legal requirements includes legislation requiring ASMFs to be filed using eCTD format and QP assurance that APIs are GMP compliant under EU’s Falsified Medicines Directive (FMD). The regulatory requirements continue to evolve.

How Woodley BioReg assists API manufacturers

Woodley BioReg offers a specialist service tailored to API manufacturers by developing a strategy of engagement with the EU and the US pharmaceutical industry. Our specialist consultants have direct experience of non-EU API manufacture and transferring technology from Asia to the West, including submissions preparation and being the central point of contact for all dialogue with the governing body in the UK (MHRA) and EU (EMA). WBR’s flexible resourcing allows the most effective and efficient resource deployment.