Aptar Pharma’s Nanopharm Facility Earns MHRA GMP Certification, Strengthening Global Support for Inhaled and Nasal Drug Development
Aptar Pharma, a global leader in drug delivery systems, dosing technologies, protection solutions, and pharmaceutical development services, has announced that its Nanopharm facility in Wales has received a Certificate of Good Manufacturing Practice (GMP) Compliance from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The certification follows a successful regulatory inspection and represents a significant milestone in the continued expansion of Aptar Pharma’s pharmaceutical services business.
Nanopharm is widely recognized for its expertise in the development and analytical testing of orally inhaled and nasal drug products (OINDPs), supporting pharmaceutical and biotechnology companies from early-stage research through clinical development, regulatory submissions, and commercial manufacturing. The newly awarded GMP certificate confirms that the facility meets applicable regulatory standards for pharmaceutical quality systems and analytical operations, while also enabling the company to broaden the range of regulated services it can provide to customers.
The achievement further strengthens Aptar Pharma’s global network of GMP-compliant analytical laboratories and reinforces its strategy of offering end-to-end development support for complex drug products through scientifically integrated service platforms.
Regulatory Milestone Validates High Quality Standards
The MHRA inspection evaluated Nanopharm’s pharmaceutical quality management system, operational procedures, facilities, personnel, and laboratory practices against current Good Manufacturing Practice (cGMP) requirements applicable to pharmaceutical analytical services.
Following completion of the inspection, the agency issued a Certificate of GMP Compliance after determining that the facility met applicable regulatory expectations at the time of inspection.
Importantly, the inspection concluded without any critical observations, highlighting the robustness of Nanopharm’s quality systems and operational controls.
Although Nanopharm had already been conducting activities aligned with GMP requirements in support of inhaled and nasal drug development programs, the formal certification provides independent regulatory confirmation of compliance and expands the scope of regulated services the facility is authorized to deliver.
For pharmaceutical companies, regulatory recognition from the MHRA offers additional confidence that analytical work performed at the facility adheres to internationally recognized quality standards.
Expanding Analytical Services for OINDPs
The new certification significantly enhances Nanopharm’s ability to support pharmaceutical developers working on orally inhaled and nasal drug products.
OINDPs represent one of the most technically challenging pharmaceutical dosage forms due to the complexity of formulation development, aerosol performance, device compatibility, manufacturing controls, and regulatory requirements.
Developing these products requires specialized analytical expertise capable of accurately characterizing both the formulation and delivery system throughout the product lifecycle.
With MHRA GMP certification now in place, Nanopharm is positioned to provide a broader portfolio of regulated analytical services, including:
- Batch release testing
- Stability studies
- Chemistry, Manufacturing and Controls (CMC) analytical testing
- Product characterization
- Regulatory submission support
- Commercial analytical services
These capabilities complement the company’s existing scientific expertise in formulation development and inhalation science, allowing clients to consolidate development activities with a single service provider.
Supporting the Entire Product Lifecycle
One of the primary advantages of the expanded service offering is the ability to support pharmaceutical programs across multiple stages of development.
Traditionally, companies developing inhaled or nasal medicines often engage different organizations for early research, analytical method development, GMP testing, regulatory support, and commercial analytical services.
Managing multiple vendors can introduce complexity, increase timelines, and require repeated technology transfers between organizations.
Nanopharm’s expanded GMP capabilities enable customers to maintain continuity throughout development by working with one scientifically integrated partner from early preclinical research through commercial product support.
This integrated approach offers potential benefits including:
- Improved project continuity
- Reduced technology transfer requirements
- Consistent quality systems
- Streamlined regulatory documentation
- Enhanced scientific collaboration
- Greater operational efficiency
By reducing fragmentation throughout development, Aptar Pharma aims to simplify the pathway from laboratory innovation to commercial product launch.
Expertise in Inhaled and Nasal Medicines
Nanopharm has built a strong reputation as a specialist organization focused exclusively on inhaled and nasal drug development.
These dosage forms present unique scientific and regulatory challenges that differ significantly from conventional oral or injectable medicines.
Successful development requires expertise in areas such as:
- Aerosol science
- Particle engineering
- Device performance
- Nasal drug delivery
- Pulmonary deposition
- Bioequivalence testing
- In vitro performance testing
Because inhaled medicines rely on both formulation characteristics and delivery device performance, comprehensive analytical evaluation is essential throughout development.
Nanopharm’s specialized scientific capabilities allow pharmaceutical companies to navigate these complexities while generating data that supports regulatory approval.
Supporting Regulatory Submissions
Another important benefit of the expanded GMP certification is strengthened support for global regulatory submissions.
Analytical testing performed under GMP conditions plays a critical role in demonstrating product quality, consistency, stability, and manufacturing control.
The facility now offers regulated analytical services supporting Chemistry, Manufacturing and Controls documentation required for submissions to regulatory authorities.
CMC packages represent a fundamental component of pharmaceutical regulatory applications and provide evidence that products can be manufactured consistently according to established quality standards.
Having analytical development and GMP testing performed within the same organization may improve efficiency while facilitating communication between scientific teams responsible for generating regulatory data.
Building an Integrated Development Partner
The certification aligns closely with Aptar Pharma’s broader strategy of expanding beyond drug delivery technologies into comprehensive pharmaceutical development services.
In addition to manufacturing drug delivery systems and packaging technologies, the company has continued investing in scientific services that support pharmaceutical innovation throughout product development.
Nanopharm’s newly certified capabilities strengthen this integrated service model by enabling pharmaceutical companies to access:
- Product development expertise
- Analytical method development
- GMP analytical testing
- Stability studies
- Regulatory support
- Commercial lifecycle services
This combination allows Aptar Pharma to serve as a long-term strategic partner rather than a provider of isolated development activities.
Leadership Highlights Investment in Quality
Gemma Budd, General Manager of Nanopharm, described the certification as the result of substantial investment in quality systems, operational excellence, and scientific capabilities.
She explained that the achievement reflects Aptar Pharma’s long-term commitment to building a high-quality GMP-compliant organization capable of supporting complex pharmaceutical development programs.
According to Budd, the certification further strengthens Nanopharm’s position as a trusted partner for companies developing inhaled and nasal medicines while expanding the integrated service offering available through Aptar Pharma Services.
She also acknowledged the commitment of the Nanopharm team in maintaining operations aligned with applicable regulatory requirements and delivering high-quality scientific support for customers worldwide.
Strengthening Aptar’s Global Quality Network
Manjiri Kaundinya, Vice President of Quality & Regulatory Compliance for Global Pharma at AptarGroup, emphasized the broader significance of the certification within the company’s international operations.
She noted that the MHRA-certified facility in Europe complements Aptar Pharma’s existing FDA-inspected cGMP analytical laboratories in North America, including:
- Gateway Analytical
- Aptar Pharma Services, Inc., Boonton
Together, these facilities create a global analytical network capable of supporting pharmaceutical customers across multiple regions while maintaining consistent quality standards.
According to Kaundinya, the expansion demonstrates Aptar’s ongoing commitment to regulatory compliance not only within its manufacturing operations but also across the pharmaceutical development services it provides.
Responding to Industry Demand
Demand for outsourced pharmaceutical development services continues to grow as biotechnology companies and pharmaceutical manufacturers seek specialized expertise without investing in extensive internal infrastructure.
The complexity of inhaled and nasal drug products has further increased the need for experienced development partners capable of supporting both scientific and regulatory requirements.
As more advanced therapies, combination products, and novel delivery systems enter development, integrated service providers with specialized expertise are becoming increasingly valuable.
Nanopharm’s expanded capabilities position Aptar Pharma to respond to this growing demand while helping clients accelerate development timelines and manage increasingly sophisticated regulatory expectations.
Supporting Innovation in Drug Delivery
Inhaled and nasal drug delivery continue to play an expanding role in modern medicine.
Beyond traditional respiratory therapies, these delivery routes are increasingly being explored for vaccines, biologics, central nervous system therapies, emergency medicines, and systemic drug delivery.
As innovation accelerates, pharmaceutical developers require analytical partners capable of supporting novel formulations and increasingly complex delivery technologies.
Nanopharm’s scientific specialization combined with GMP-certified analytical operations provides a strong foundation for supporting these evolving therapeutic approaches.
The MHRA’s issuance of a Certificate of Good Manufacturing Practice Compliance to Aptar Pharma’s Nanopharm facility marks a significant achievement in the company’s ongoing expansion of pharmaceutical development services. By formally recognizing the facility’s quality systems and analytical capabilities, the certification enables Nanopharm to provide an even broader range of regulated services supporting the development and commercialization of orally inhaled and nasal drug products.
Combined with Aptar Pharma’s established expertise in drug delivery technologies and its global network of FDA-inspected analytical laboratories, the newly certified facility strengthens the company’s ability to serve as an integrated development partner throughout the pharmaceutical product lifecycle. From early formulation development and analytical testing to batch release, stability studies, CMC support, and commercial activities, pharmaceutical companies can now benefit from greater continuity, regulatory alignment, and scientific expertise.
As demand continues to grow for specialized partners capable of supporting increasingly complex inhaled and nasal therapies, Aptar Pharma’s investment in GMP-compliant analytical infrastructure reinforces its commitment to helping pharmaceutical innovators bring high-quality medicines to patients worldwide with greater efficiency, consistency, and confidence.
About Nanopharm
Nanopharm is an Aptar Pharma company and part of AptarGroup, Inc., a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing. A specialist pharmaceutical product development organization focused on orally inhaled and nasal drug products (OINDPs), Nanopharm applies fundamental science and engineering rigor to accelerate the development of complex inhaled therapies, from early feasibility through to clinical supply. For more information, please visit www.nanopharm.co.uk and www.aptar.com.