Where a risk can be
solved by a wall,
we build the wall.
Three manufacturing units, WHO-GMP certified and PIC/S aligned, engineered so that quality does not depend on anyone having a good day. Segregation is architectural. Release authority is independent. Traceability runs from the incoming API lot to the pharmacy counter.
Contamination is
an architecture
problem.
Most quality failures in our industry are not caused by careless people. They are caused by facilities that require people to be perfect — shared air handling, shared corridors, shared equipment, and a procedure asking everyone to remember the right sequence every single time.
We take the opposite approach. Where a risk can be eliminated by a wall, we build the wall. Beta-lactams and cephalosporins are produced in physically separate buildings with independent air, independent people-flow and independent effluent. It costs considerably more than a well-written standard operating procedure. It also cannot be forgotten on a difficult Thursday.
First-pass batch release rate
Critical observations in our last three regulatory audits
Three units.
One standard.
Unit I — General Formulations
Solid-dose and liquid orals across tablets, capsules, suspensions and syrups. Our original facility, rebuilt twice, and still the line where most of the portfolio is made.
Unit II — Cephalosporin Block
A physically separate building with independent air handling, personnel airlocks and dedicated effluent treatment. Segregation is architectural here, not procedural.
Unit III — Sterile & Biologics
Under construction, designed from the first drawing against a PIC/S brief rather than retrofitted toward one. Grade A/B fill-finish with isolator technology.
See the segregation
for yourself.
The airlocks, the pressure cascades, the separate people-flow. Easier to show than to describe in a specification document.
Independent air handling, independent people-flow, independent effluent.
Five gates.
Any one of
them stops it.
A batch passes through five independent checkpoints between raw material and release. Each one has the authority to halt it, and none of them reports to the person whose production target it would inconvenience.
Governance
Our QA and QC functions report directly to the board. In seventeen years, no production deadline has overridden a release decision — a fact we can demonstrate from the record, not merely assert.
Every API and excipient lot is quarantined on arrival and sampled under laminar flow. Identity, assay, and impurity profile are verified against our own specification — not merely the supplier's certificate of analysis, which we treat as a claim to be tested rather than a fact to be filed.
Weight variation, hardness, friability, disintegration and content uniformity are checked at defined intervals throughout every batch. Out-of-trend results trigger investigation before they become out-of-specification results.
Full analytical release testing including assay, dissolution, related substances and microbial limits. No batch leaves quarantine without a signature from a person with the authority to refuse it.
Real-time and accelerated stability chambers run continuously under ICH conditions, with data supporting every shelf-life claim we print on a carton.
Viable and non-viable particle counts, differential pressure, temperature and humidity logged continuously across all classified areas, with automated alerting on excursion.
From lot number
to bedside.
Sourcing
Qualified suppliers only, audited on site. Every incoming lot quarantined and independently tested against our specification.
Manufacture
Segregated blocks, validated equipment, continuous environmental monitoring and in-process control at defined intervals.
Release
Full analytical testing. A named person with independent authority signs — or refuses to.
Distribution
Serialised coding and validated cold chain, with data-logger verification at every handover point.
Audited, not
self-declared.
Every certification below was granted by an external body that came, looked, and could have said no.
WHO-GMP
Good Manufacturing Practice certification across all operational units
ISO 9001:2015
Quality management systems
ISO 14001:2015
Environmental management systems
ISO 45001:2018
Occupational health and safety
DRAP
Drug Regulatory Authority of Pakistan — full establishment licence
GLP
Good Laboratory Practice across analytical and stability functions
Halal
Certified by the Halal Certification authority for applicable products
PIC/S aligned
Unit III designed to Pharmaceutical Inspection Co-operation Scheme standards
Come and inspect it
for yourself.
We host partner and regulatory audits throughout the year. If you are evaluating us as a supplier, the most useful thing we can offer is a walk through the plant.