Infrastructure
API Manufacturing Infrastructure, From Laboratory to Scale
A cGMP- and WHO-compliant manufacturing facility built for scale, from kilo lab to bulk production.
HVAC-Controlled Production
Manufacturing takes place in a controlled environment maintained by an HVAC system, operated per ICH guidelines.
Kilo Lab & Pilot-Scale Development
An extensive range of kilo and pilot-scale facilities supports cGMP synthesis of niche APIs, from first batches to scale-up.
Reactors & High-Pressure Autoclaves
27 glass-lined and stainless-steel reactors with a combined capacity of over 138 KL, plus 3 dedicated hydrogenation autoclaves totaling 12 KL.
Integrated R&D & Technology Transfer
Our integrated R&D center enables maximum interaction between teams, ensuring seamless process technology transfer from laboratory to plant.
Analytical, Micro & Chemical Labs
Dedicated analytical instrumentation, microbiology and chemical laboratories operate under internationally recognized equipment qualification and change-control procedures.
Segregated Warehousing
Raw materials and finished API are stored in fully segregated warehousing, keeping incoming and outgoing material streams clearly separated.
Manufacturing Capabilities
Reactors, Filtration & Drying Equipment
| Equipment | No(s) | Total Capacity |
|---|---|---|
| Glass Lined Reactor | 7 | 20.98 KL |
| Stainless Steel Reactor | 20 | 117.28 KL |
| Autoclave (Hydrogenator) | 3 | 12 KL |
| Centrifuge with Bag Lifter | 5 | 24" / 36" / 48" |
| Sparkler Filter | 4 | — |
| Nautch Filter | 1 | 2 KL |
| Candle Filter | 1 | 5 L |
| Leaf Filter | 1 | 25 L |
| Dryer (FBD) | 3 | 490 Kg |
| ANFD | 3 | 13 KL |
| Blender | 2 | 2 KL & 200 L |
| Sifter | 2 | 30" and 48" |
| Multi Mill | 1 | 500 kg/hr |
| Tray Dryer | 1 | 6 Tray |
Reaction Capabilities
- Alkylation
- Friedel-Crafts Acylation
- Nitration
- Halogenation
- Hoffmann Reaction
- Oxidation
- Reduction
- Condensation
- Grignard Reaction
- Catalytic Reduction / High-Pressure Reaction
R&D & Technology Transfer
From Lab Bench to Pilot Plant
- 01Equipped to carry out numerous types of organic reactions, with process development up to 5 kg scale
- 02Scientists holding Doctorate and Master's degrees in Chemistry
- 030.25 KL & 0.63 KL glass-lined and stainless-steel reactors with full utilities
- 04Pilot plant controlled with an HVAC system
- 05Autoclaves of 2 L and 25 L, plus glass assembly from 1 L to 100 L
- 06Dedicated vacuum and recovery systems
- 0724" centrifuge and filtration, with a 24-tray VTD
Quality Control Laboratory
Instrumentation per 21 CFR Part 11 & cGMP
Our QC laboratory covers sample receipt, analysis and reporting, sampling procedures, equipment qualification, analytical method validation, impurity profiling, stability testing, reference and working standard management, calibration, and resolution of out-of-specification results.
| Instrument | No(s) |
|---|---|
| HPLC | 02 |
| HSGC | 02 |
| Vacuum Oven | 01 |
| IR | 01 |
| UV Spectrophotometer | 01 |
| Polarimeter | 01 |
| K.F. Titrator | 01 |
| M.P. Apparatus | 01 |
| pH Meter | 02 |
| Conductivity Meter | 01 |
| Hot Air Oven & Vacuum Oven | 03 |
| Digital Balance (up to 5 digit) | 03 |
| BOD | 02 |
| Autoclave | 02 |
| Stability Chamber | 03 |
Utilities
Facility Utilities & Support Systems
| Utility | Capacity |
|---|---|
| HVAC / AHU | 6 Nos |
| FAU | 11 Nos |
| EAU | 9 Nos |
| Steam Boiler | 3000 Kg/hr |
| Chilling Plant | 120 TR |
| Brine Plant | 2 Nos, 30 TR up to -30°C |
| Water Injector Pump (incl. High Vacuum) | 6 Nos, 5 Kg/hr |
| Cooling Tower | 4 Nos, 60–600 TR |
| Purified Water Plant (HSED) | 1000 L/hr |
| Scrubber | Amine and Alkali |
| DG Set | 625 KVA |
| Air Compressor | 2 Nos |
Regulatory Documentation
Built to support DMF and CTD documentation from day one
Every facility system above feeds directly into our regulatory documentation process, so DMFs, CTDs and other technical packages are backed by traceable, qualified equipment and change-control records.
See what this infrastructure produces in our API portfolio, or discuss scale-up or production requirements with our team.