CustomPharma

A full-service contract development and manufacturing organisation (CDMO) for clinical and commercial medicinal products.

[CustomPharma @CustomPharma]

We have an annual capacity of over 1.5 billion tablets and 250 million capsules, but what sits behind that is a site designed for sustained high-volume output. Our processes and operational structure ensure we can run reliably at scale, rather than just hit targets.

[CustomPharma @CustomPharma]

Immediate-release tablets need to one thing reliably: dissolve as intended, every time.

That means the manufacturing process (compression force, blend uniformity, coating where applied) has to hold across every batch, not just during development.

[CustomPharma @CustomPharma]

We apply aqueous film coats for both cosmetic and performance purposes, whether that's protecting the tablet during handling, masking taste or controlling where and how it dissolves.

The coating is part of the product specification, not a finished step applied after the fact.

[CustomPharma @CustomPharma]

PVC/PVDC, Aclar and Alu/Alu each offer different moisture and oxygen barrier levels. The right selection comes from the stability data, not from cost or convenience alone.

Getting it right early avoids shelf-life problems further down the line.

[CustomPharma @CustomPharma]

Our on-site QC lab runs routine analysis as part of the release programme, covering the checks needed to support QP batch certification.

Keeping the lab close to manufacturing means turnaround is faster and nothing falls into the gaps between sites.

[CustomPharma @CustomPharma]

Serialisation is required under EU FMD, but the value extends beyond compliance.

Each unit carries a unique identifier through pack-out and into the supply chain, which means traceability doesn't stop at the factory gates.

[CustomPharma @CustomPharma]

Capsule filling is more demanding than it looks, particularly when the formulation has specific requirements.

We use MG2 equipment for hard gelatin capsule manufacture.

The result is consistency across batch sizes and fill types, without compromising accuracy.

[CustomPharma @CustomPharma]

We run high-speed compression with controls in place to keep critical quality attributes consistent across batches - not just within a single run.

That repeatability is what makes commercial supply predictable over time.

[CustomPharma @CustomPharma]

We manufacture a range of controlled substances on-site, with the scheduling, oversight and documentation needed to keep supply running without gaps.

It's the same discipline applied to every batch, not just when it's being watched.

[CustomPharma @CustomPharma]

Manufacturing high-potency tablets requires more than standard compression line.

We produce high-potency oral solid dose forms. This protects operators without compromising manufacturing process or output quality.

Consistent results depend on the right controls from the start.

[CustomPharma @CustomPharma]

Roller compaction is often the right choice when wet granulation isn't an option.

If actives are moisture or heat-sensitive, a dry granulation route removes a variable that could affect stability or performance.

It's a straightforward decision when the chemistry makes it clear.

[CustomPharma @CustomPharma]

Tech transfer is only as good as the groundwork behind it.

We work through all the documentation; specifications, process parameters, analytical methods are all reviewed before anything moves to the manufacturing floor.

Preparation makes the manufacturing run without surprises.

[CustomPharma @CustomPharma]

A licensed MHRA facility is a baseline requirement for commercial manufacture.

Maintaining that licence means consistent standards across production, quality systems and documentation.

Our track record reflects a facility that runs the same way it presents.

[CustomPharma @CustomPharma]

It works well for moisture-sensitive formulations where wet granulation isn't suitable and produces a consistent granule that behaves predictably on the press.

When the formulation calls for it, it's a reliable option - not a workaround.

[CustomPharma @CustomPharma]

QP batch certification isn't a formality at the end of the process - it depends on everything that comes before it.

Because manufacture, testing and certification sit under the same roof, that review runs without unnecessary hold-ups.

[CustomPharma @CustomPharma]

Routine release testing runs alongside manufacturing and packaging, which means results aren't waiting on an external lab queue before decisions can be made.

Faster answers reduce disruption and keep supply moving.

[CustomPharma @CustomPharma]

Bottle packaging comes with its own set of variables that all need to work together.

Our lines support push-fit and induction-sealed screw-cap, with tablet count by mass via electromagnetic field detection not optical counting.

Keeping accuracy consistent without bottlenecks.

[CustomPharma @CustomPharma]

PVC/PVDC, Aclar and Alu/Alu offer different levels of moisture and oxygen barrier protection, with different cost & regulatory considerations.

We work through the choice early - with stability data and market requirements in mind - before it becomes a problem to unpick.

[CustomPharma @CustomPharma]

In-line sterilisation is a standard requirement for many markets.

Our packaging lines run high-speed serialisation built into both blister and bottle processes, meeting EU Falsified Medicines Directive requirements.

Keeping pack-out efficient without compromising traceability.

[CustomPharma @CustomPharma]

Manufacturing controlled drugs isn't a specialist departure from our normal operations.

We hold a Home Office licence and handle scheduled substances as part of our routine productions.

It means our clients don't need to build something separate around it.