Approvals
What we hold, and what it covers
WHO-GMP
Both units, covering oral solids, oral liquids and topicals. Renewed and re-inspected on the state licensing authority cycle.
Revised Schedule M
Compliant premises with segregated air handling, defined pressure cascades and qualified utilities.
ISO 9001:2015
Quality management system spanning manufacturing, warehousing, dispatch and customer complaint handling.
CDSCO / State FDA
Manufacturing licences in Form 25 and Form 28 for the listed product categories.
FSSAI
Nutraceutical and food-supplement range manufactured and labelled under a separate licence.
GeM & rate contracts
Registered supplier for government health procurement, with active rate contracts in three states.
Facilities
Two sites, separated by product type
| Facility | Blocks | Products | Area | QC laboratory |
|---|---|---|---|---|
| Unit 1Oral solids & liquids | A — tablets and capsules C — syrups and dry syrups | Tablets, capsules, oral liquids, dry syrups | 42,000 sq ft | On site, with microbiology |
| Unit 2Topicals & nutrition | T — creams, gels, ointments N — sachets and powders | Semi-solids, sachets, nutraceuticals | 26,000 sq ft | On site |
Both sites operate dedicated warehousing with segregated quarantine, approved and rejected areas, and temperature-monitored storage for products requiring it.
Batch lifecycle
What a batch goes through before it leaves
- Incoming materials
- API and excipients are quarantined on receipt and released only after identity, assay and microbial limit testing against the approved specification. Vendors are on an audited approved list.
- Dispensing
- Weighed in a dedicated dispensing booth under reverse laminar airflow, double-checked and signed by two people.
- Processing
- Manufactured against an approved batch manufacturing record. Any deviation is logged, investigated and closed before the batch proceeds.
- In-process checks
- Weight variation, hardness, thickness, friability and disintegration recorded at fixed intervals through the compression run; fill volume and pH for liquids; viscosity and spreadability for semi-solids.
- Finished goods testing
- Assay, dissolution, related substances, uniformity of content and microbial limits as applicable, with results reviewed against the specification before release.
- Release
- Held in quarantine until the Head of Quality Assurance signs the release certificate. Nothing is dispatched on a verbal clearance.
- Retention
- A retained sample from every batch is kept under label storage conditions for shelf life plus one year, alongside the complete batch record.
Laboratory
Instruments on site
Chromatography
HPLC with UV and PDA detection, gas chromatography with headspace for residual solvents.
Spectroscopy
UV-visible spectrophotometry and FTIR for identity confirmation.
Dissolution
USP Apparatus I and II with auto-sampling, used for release and for comparative profiling.
Physical testing
Hardness, friability, disintegration, tap density, moisture by Karl Fischer and loss on drying.
Microbiology
Laminar airflow, incubators and autoclave for microbial limits, bioburden and water testing.
Stability chambers
Mapped and alarmed chambers at 25 °C/60% RH, 30 °C/65% RH and 40 °C/75% RH.
Water system
Purified water generation with continuous conductivity and TOC monitoring, sanitised on a defined cycle.
Environment
Differential pressure, temperature and humidity logged for all classified areas.
Audits
We expect to be inspected
Customer and partner audits are welcome and are scheduled without special preparation. Documentation is maintained so that it can be produced on the day rather than assembled for the occasion.
Self-inspection runs on an annual plan covering every department. Supplier audits are carried out for all API vendors and for excipient vendors classified as critical. Complaints, deviations, out-of-specification results and change controls are tracked to closure with defined timelines, and reviewed in a monthly quality management review.