Aptar Pharma, a global leader in drug delivery, dosing, protection technologies and services,  announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Certificate of Good Manufacturing Practice (GMP) Compliance following its inspection of Aptar Pharma’s Nanopharm facility in Wales. Nanopharm specializes in the product development and analytical testing of orally inhaled and nasal drug products (OINDPs), supporting pharmaceutical companies from early preclinical development through to regulatory submissions and commercialization. The certification represents an important milestone in the continued development of Nanopharm’s quality systems and regulated analytical capabilities.

The inspection evaluated Nanopharm’s pharmaceutical quality system, facilities and operational practices against applicable regulatory requirements, with no critical observations. Nanopharm had already been operating in accordance with GMP requirements, delivering services in support of OINDP development. The first MHRA inspection and resulting GMP certificate confirm the MHRA’s conclusion that the inspected facility complied with applicable GMP requirements at the time of inspection. It also enables the site to provide additional services that fall within the scope of the inspection.

Providing these cGMP analytical services for OINDPs complements Nanopharm’s well-established product development capabilities and enables customers to work with a single, scientifically integrated partner across a greater portion of the product lifecycle. Customers can transition more seamlessly from early development through to late-stage and commercial activities, supported by consistent quality systems, deep scientific expertise and regulatory alignment. Nanopharm’s services include analytical testing for batch release, stability studies and a broad range of Chemistry, Manufacturing and Controls (CMC) analytical activities supporting regulatory submissions across inhaled and nasal dosage forms.

Gemma Budd, General Manager, Nanopharm, an Aptar Pharma company, commented, “This milestone reflects the significant investment Aptar Pharma has made in building a high-quality, GMP-compliant organization and the commitment of the Nanopharm team to operating in line with applicable regulatory requirements. The MHRA certification strengthens Nanopharm’s position as a trusted partner for companies developing complex inhaled and nasal medicines and further supports Aptar Pharma Services’ integrated offering for pharmaceutical companies worldwide.”

Manjiri Kaundinya, Vice President, Quality & Regulatory Compliance, Global Pharma, AptarGroup, added, “Alongside Aptar Pharma’s FDA-inspected cGMP analytical facilities in North America - Gateway Analytical and Aptar Pharma Services, Inc., Boonton - this expanded presence in Europe reinforces Aptar’s commitment to quality and regulatory compliance, not only within its manufacturing operations but also across the services it provides to its pharmaceutical customers.”

Pharmaceutical companies developing OINDPs can contact the Aptar Pharma and Nanopharm teams to learn more about these expanded capabilities and how they may support their development programs.