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[BUSINESS] · United Kingdom · 2 sources

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Upperton Pharma Solutions secures MHRA approval for sterile manufacturing

Upperton Pharma Solutions has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to begin GMP manufacture of sterile investigational medicinal products at its new facility in Nottingham.

The 7,000-square-foot facility, located at Trent Gateway, was designed in alignment with the revised EU GMP Annex 1 framework. This regulatory approval extends the company’s existing Manufacturing and Importation Authorization for Investigational Medicinal Products (MIA(IMP)) to include sterile clinical supply.

The new operation is intended to support sterile drug product programs from formulation development through early clinical manufacture, specifically targeting projects moving toward first-in-human studies and early-stage clinical trials. The facility features Grade A isolator environments and a comprehensive Contamination Control Strategy to ensure quality and patient safety.

Entities

Medicines and Healthcare products Regulatory Agency · Nottingham