The Active Pharmaceutical Ingredient (API) industry supplies pharmaceutical manufacturers with raw materials for subsequent processing and formulation into saleable pharmaceutical products. Drugs are typically composed of two main component types: an active ingredient, which is either chemically active or has some biological activity, and an excipient, which is the substance of the product, holds the product in suspension and is usually inert. Other components may be present to render stability, solubility, or other favourable properties.
LEGISLATION IN API MANUFACTURING
The intermediate manufacturer 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), Certificate of Suitability (COS), etc. 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 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 (CERTIFICATION) or DRUG MASTER FILE (DMF)
• A CERTIFICATION OF SUITABILTY to the European Pharmacopoeia monographs (CEP) CERTIFICATE OF SUITABILITY (COS)
These documents contain details of the raw materials used, production process, formulation, batch release, testing, etc. API manufacturers must also be compliant with good manufacturing practice (cGMP).
RECENT TRENDS IN THE API INDUSTRY
Recent trends in the API industry include a move for larger pharmaceutical manufacturers to increasingly outsource elements of its supply chain, including ingredient manufacture, to more cost-effective suppliers. At the same time there has been rapid growth in production of APIs in non-EU regions such as India, China and other parts of Asia, and a stronger desire to supply these APIs into the EU and the US. Many of the “emerging market” API manufacturers and suppliers now face the challenge of understanding the complex legislative landscape of the EU and US. These include interpreting the requirements they need to meet, liaising with the relevant boards of health, to secure and maintain the correct regulatory accreditation and compliance. An example of one such change is the legislation that requires ASMFs to be filed using eCTD format. A further example includes the assurance of API GMP under EU’s Falsified Medicines Directive (FMD).
HOW WOODLEY BIOREG HELPS 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. WBR has specialist consultants with direct experience of non-EU API manufacture and transferring technology from Asia into the West and provide services such as preparing submissions for the relevant regulatory applications, and being the central point of contact for all dialogue with the governing body, in the UK this would be the MHRA. Flexible resourcing allows the most suitable solution to be implemented to allow this.
For more information on API manufacturing, please contact us