Coating suite 01
200 kg
Specialty API layering
Bottom-spray Wurster fluid bed coater for specialty high-value campaigns and validation batches.
Hyderabad campus
Production-scale coating and blending.
Three fluid bed coaters up to 500 kg, high-capacity SS-316 blending, epoxy-coved cleanrooms, and closed-loop recirculation air handling in Kukatpally.
Engineered for cGMP and revised Schedule M.
The multi-suite plant in IDA Gandhi Nagar operates in accordance with Good Manufacturing Practices and revised Schedule M guidelines.
Processing corridors and manufacturing suites use seamless epoxy flooring with rounded coving, so particulate does not collect in corners and line clearance between campaigns stays practical.
Production runs across three shifts plus a general shift, with captive diesel generator backup and a dedicated substation transformer.
- 3
- Production shifts
- 10
- Air handling units
- 500 kg
- Largest FBC
Coating infrastructure
Fluid bed coaters.
Three independent suites with production-scale bottom-spray processors, peristaltic delivery and pneumatic product transfer.
Coating suite 02
300 kg
Enteric and sustained release
High-efficiency fluidisation for intermediate commercial batches and enteric coatings.
Coating suite 03
500 kg
High-capacity bulk runs
High-payload processor for large commercial campaigns including itraconazole, PPIs and statins.
Blending, drying and sifting.
Double cone blender
1,500 L · SS-316
Uniform combination blending of multi-pellet populations, such as omeprazole EC with domperidone SR, at low shear.
48-tray dryers
Two units
Electric and steam heated convection ovens with digital temperature logging for polymer film curing.
Vibro sifter
30-inch diameter
Particle classification that removes fines and oversize twins before capsule filling.
How it works
Thirteen stages, in the order the batch moves.
From receipt and quarantine through coating, release, and dispatch — the order a batch travels through the plant.
01–03·PulverizationScroll
How it works
Thirteen stages, in the order the batch moves.
From receipt and quarantine through coating, release, and dispatch. The sequence below is the plant order, without photographs.
01
Receipt of Ingredients
Quarantine, Verification & Sampling
Raw active pharmaceutical ingredients (APIs) and excipients arrive at the facility, enter the Quarantine Zone, and are logged into QA records. Dedicated downflow sampling booths ensure controlled environmental conditions and particulate containment.
- Equipment
- Quarantine Bay & Downflow Sampling Booth
- Critical controls
- Container integrity inspection, approved vendor verification, raw material sampling protocols, and quarantine hold tagging.
02
Pulverization
Milling & Particle Size Uniformity
Active powders and functional excipients are de-lumped and pulverized to uniform dimensions. Uniform particle size distribution is critical for continuous suspension spray without nozzle clogging.
- Equipment
- GMP Model Stainless Steel Pulverizer
- Critical controls
- Screen aperture verification, rotor RPM regulation, and post-milling sieve retention analysis.
03
Blending
Homogenous Dry Dispersion Pre-Mix
Pulverized excipients and functional binders are tumble-blended to achieve homogenous distribution of active and excipient blend before compounding into liquid spray suspensions or solution feeds.
- Equipment
- Octagonal Tumbling Blender
- Critical controls
- Tumble duration, rotational speed, and blend uniformity verification.
04
Drug Coating (Layering)
Fluid Bed Precision Active Deposition
Neutral sugar spheres or starter cores are fluidized inside our Fluid Bed Coaters (200 kg / 300 kg / 500 kg). The drug solution or suspension is atomized onto the circulating cores.
- Equipment
- Fluid Bed Coater (200 / 300 / 500 kg) & Jacketed Solution Tanks
- Critical controls
- Inlet air temperature, atomization pressure, spray rate, and product bed temperature.
05
In-Process Drying
Moisture Removal & Core Stabilization
Active-layered pellets are conditioned under controlled heated fluidization or in 48-tray dryers to eliminate residual processing solvents and stabilize the active film matrix.
- Equipment
- FBC Fluidized Drying Loop & 48-Tray Dryers
- Critical controls
- Bed temperature profiling, exhaust moisture monitoring, and Loss on Drying (LOD) parameter controls.
06
Sifting (Fines & Agglomerates)
Particle Size Classification
Pellets are classified through our 30" multi-deck Vibro Sifters to isolate the target sieve fraction, effectively removing undersized fines and any twin-particle agglomerates.
- Equipment
- 30-Inch Multi-Deck Vibro Sifter
- Critical controls
- Screen integrity check, mesh classification compliance, and particle size distribution (PSD) verification.
07
Sub Coating
Protective Barrier Seal Application
A neutral protective polymer sub-coat barrier is applied over the active drug layer. This insulates sensitive molecules from ambient moisture and prevents chemical interaction with subsequent functional coating polymers.
- Equipment
- Fluid Bed Coater (Coating Suite)
- Critical controls
- Sub-coat weight gain, film continuity, and barrier integrity.
08
Enteric / Functional Coating
Release Rate & Gastro-Resistant Membrane
For EC formulations, functional enteric polymers are applied to achieve gastro-resistance in acidic conditions. For SR formulations, controlled diffusion membranes are applied.
- Equipment
- Fluid Bed Coater (200 kg / 300 kg / 500 kg)
- Critical controls
- Polymer weight gain, spray atomization parameters, inlet air volume, and drying balance.
09
Post-Coating Drying & Sifting
Film Curing & Final Grading
Finished pellets undergo final thermodynamic curing in 48-tray dryers to ensure complete film formation. A final pass through calibrated vibro sifters ensures strict adherence to target mesh specifications.
- Equipment
- 48-Tray Dryers & 30" Vibro Sifter
- Critical controls
- Curing temperature and duration, residual solvent verification by QC, and mesh size compliance.
10
Final Blending
Homogenization & Combination Formulation
Pellets are charged into our 1,500 L SS-316 Double Cone Blender. For single-drug formulations, lubricating glidants are blended. For combination products, two distinct multiparticulate populations are blended uniformly.
- Equipment
- SS-316 Double Cone Blender (1,500 L Capacity)
- Critical controls
- Blending duration, rotation speed, and blend uniformity testing.
11
Packing
Controlled Cleanroom Packaging
Finished pellets are packed into pharmaceutical poly bags, sealed, and placed into HDPE containers or fiber drums with batch identification labels.
- Equipment
- Controlled Cleanroom Packaging Suite
- Critical controls
- Container weighing accuracy, primary liner seal integrity, and batch labeling verification.
12
QC Testing & Batch Release
Comprehensive Analytical Verification
Representative batch samples are analyzed in the QC Laboratory for Assay, Dissolution, Moisture Content (KF), Impurities (HPLC), and Particle Size. QA completes document review for batch release.
- Equipment
- HPLC, 8-Bowl Dissolution Tester, UV-VIS, KF Titrator
- Critical controls
- Pharmacopoeial monograph specifications (IP/USP/BP), Certificate of Analysis (CoA) generation, and QA Head release sign-off.
13
Dispatch & Logistics
Secure B2B Supply to Formulation Partners
Released finished containers are staged in the climate-controlled Finished Goods warehouse before dispatch to domestic formulation partners or staging for export logistics with complete documentation (CoA, MSDS, batch release notes).
- Equipment
- Finished Goods Bay & Climate-Controlled Transit Logistics
- Critical controls
- Shipping temperature stability, tamper-evident seals, Bill of Lading / Transport documentation, and customer dossier packet.
First-floor cleanroom
Neutral starter spheres.
A dedicated starter-core suite on the first floor, with its own equipment and operators, supplies neutral cores to formulation partners.
Sugar pellets
Pharma-grade sucrose and starch spheres across seven mesh fractions.
30#40 · 24#30 · 20#24 · 18#20 · 16#20 · 14#18 · 60#80
Dummy pellets
Inert placebo spheres for volumetric capsule fill and encapsulation machine setup.
12#16 · 12#18 · 16#20
Utilities
Air, steam and power that keep three shifts running.
10 recirculation AHUs
Nine units at 2,000 CFM and one at 8,000 CFM, with multi-stage pre-filters and micro-filters across the production suites.
40 HP compressed air
Rotary screw compressor with refrigerated dryers supplying dry air to spray atomisers.
1.0 ton steam boiler
Process steam for jacketed solution tanks, tray dryers and HVAC coils.
Captive power
125 kVA diesel generator with AMF switchgear, and a 250 kVA dedicated substation transformer.
Discuss campaign scheduling and batch capacities.
Commercial campaigns in the 500 kg fluid bed coater, or pilot batches in the FR&D suites.