AAIPharma's plant gets EMEA GMP accreditation

By staff reporter

- Last updated on GMT

Related tags: Contract manufacturing, Pharmacology

AAIPharma's contract manufacturing facility in Wilmington, North
Carolina has received European Medicines Agency (EMEA) good
manufacturing practice (GMP) status.

The award, which follows an inspection of the facility by Sweden's Medical Products Agency (SMPA), is covered by the European Union's Mutual Recognition Procedure (MRP). The accreditation allows AAIPharma to manufacture drug tablets, capsule products and solid dose formulations for pharmaceutical clients wishing to operate in the lucrative European market. The GMP status also entitles AAIPharma to offer testing and analytical services for industrial clients wishing to supply pharmaceutical products and drug intermediates to the region. AAIPharma believes that the accreditation, coupled with the Food and Drug Administration (FDA) GMP status already held by its US production facilities, cements its position as a major player amongst contract manufacturing organisations (CMO) worldwide. Lee Karras, the firm's senior vice President of global pharmaceutical services at AAIPharma added that: "Certification of our Wilmington operations is a testament to AAIPharma's goal to provide high quality pharmaceutical contract manufacturing services to the global market."​ Earlier this year, following a $1.5m (€954,732) renovation, AAIPharma's sterile manufacturing plant in South Carolina, received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to produce aseptic and lyophilised pharmaceutical products. AAIPharma said that the award, which followed similar approval from the FDA, had positioned the plant to deliver aseptic contract manufacturing services to pharmaceutical clients wishing to supply both commercial and clinical sterile drug products throughout the US and Europe. Global CMO sector ​ Over the last few years the development of the CMO sector has been nothing short of dramatic. As global economic factors and competition have forced big pharma companies to increasingly seek outsourcing solutions for manufacturing operations, the CMO industry has blossomed into a thriving and dynamic global market. As a result, compliance with regulatory bodies around the world is vital to the ongoing success and development of firms like AAIPharma as it enables them to attract the widest range of possible industrial clients.

Related topics: Contract Manufacturing & Logistics

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