Generic development
Reverse-engineering the reference product to match release profile and impurity limits.
Innovation
Formulation science, analytical rigour and a pipeline built around what prescribers and patients actually need.
Research & development
We develop for the prescription that actually gets written.
Our development brief starts with a clinical reality: a patient who forgets doses, a child who refuses a bitter syrup, a household budget that decides whether a course is completed. Formulation choices follow from there.
That means fixed-dose combinations that cut pill burden, taste-masked paediatric forms that get finished, and pack sizes matched to standard treatment durations rather than to production convenience.
Fixed-dose combinations
Compatible actives combined into one unit, with stability proven across the shelf life.
Paediatric formats
Taste-masked granules and suspensions dosed by weight, not by guesswork.
Pipeline
What is moving through development
A stage-gate process: nothing advances until the previous gate has documented evidence behind it.
| Programme | Therapeutic area | Dosage form | Stage |
|---|---|---|---|
| Dual antihypertensive FDC | Cardiology | Film-coated tablet | Registration |
| Paediatric antibiotic granules | Anti-infectives | Dry powder suspension | Stability |
| Modified-release PPI | Gastroenterology | Enteric capsule | Pilot batches |
| Iron + folate once-daily | Nutrition | Film-coated tablet | Registration |
| Topical anti-inflammatory | Pain & inflammation | Gel | Feasibility |
Pipeline entries are indicative and subject to regulatory review. Timelines are not a commitment to launch.
Quality
Release is a decision, not a formality.
The quality unit is independent of production and holds the authority to reject. That structure is the whole point.
100%Batches released against spec
3Validation batches per process
36 moTypical stability programme
24 hrComplaint acknowledgement
In-house analytical capability
- High performance liquid chromatography for assay and related substances
- Dissolution testing across multiple media and apparatus types
- UV-visible spectrophotometry and Karl Fischer titration
- Microbiological limit testing and sterility support
- Walk-in stability chambers for long-term, intermediate and accelerated conditions
Documentation you can audit
- Batch manufacturing record for every run, reviewed before release
- Retained samples held for the full shelf life plus one year
- Supplier qualification and incoming raw material testing
- Change control, deviation and CAPA systems with traceable sign-off
- Certificates of Analysis issued on request against batch number
Q&A
R&D and quality questions
Development timelines, analytical capability and co-development terms.
Cannot find your answer? Ask the assistant in the corner of the screen, or write to us directly.
What does your R&D team work on?
Generic product development, reformulation for better tolerability, fixed-dose combinations that reduce pill burden, and taste-masked paediatric forms. Each project runs through a formal stage-gate from feasibility to commercial scale-up.
How long does a new product take to develop?
A straightforward generic typically takes 9 to 14 months from feasibility to first commercial batch, including pilot batches, six-month accelerated stability and dossier submission. Complex forms take longer.
Do you run bioequivalence studies?
Yes, where the product requires it. Studies are conducted at accredited clinical research organisations under Good Clinical Practice, and the full report is filed with the registration dossier.
Can we co-develop a product with your team?
We take on joint development where a partner brings the market and we bring formulation and manufacturing. Terms, ownership of the dossier and territory are agreed before the project starts.
What analytical capability do you have in house?
HPLC, UV-visible spectrophotometry, dissolution testing, karl fischer titration, microbiology and a dedicated stability chamber suite covering long-term, intermediate and accelerated conditions.
Have a development project in mind?
Bring us the molecule and the market. We will tell you honestly whether we are the right partner for it.