Manufacturing Plant
The state-of-the-art Embio manufacturing facility is capable to handle large volume and small volume Active Pharmaceutical Ingredients, advanced intermediates, chiral intermediates and chiral resolving agents. Facility is built and managed by fundamentals such as growth, continuity, dynamism and reform.
Facility is approved by US-FDA, TGA, WHO-GMP and KFDA. It is also approved by Japanese authorities’ foreign manufacturing site. Complimented by DEA for adhering to documentation systems for controlled substance regulations. Embio has been accredited with USP mark and certificate for Pseudoephedrine HCL.
The Mahad plant has been designed to meet the following goals:
- Technological competence to handle difficult molecules
- To supply quality products that fulfill or even surpass the stringent requirements of all major regulatory authorities and customers
- To compete and win in international markets
- The company has upgraded the facility to meet domestic and international production requirements, regulatory GMP and EHS approvals.
What began modestly as a single block API manufacturing facility, rapidly expanded to two dedicated production blocks, four multi-product production blocks and one small volume production block.
This unit has the capacity to develop and execute a wide range of unit processes and operations.
| Plant | Capacity in KL (Reactor Volume) | Major Equipment Installed |
|---|---|---|
| Fermentation | 640 KL | Fermentors |
| Ephedrine Hydrochloride | 27.6 KL | Glass Lined Reactor, SS Reactor , Centrifuge, Tray dryer, Multimill, Sifter, Blender |
| Pseudoephedrine Hydrochloride | 24.05 KL | Glass Lined Reactor, SS Reactor , Centrifuge, ANFD, Multimill, Sifter, RCD |
| MPP-1 | 29.5 KL | Glass Lined Reactor, SS Reactor , Centrifuge |
| MPP-3 | 8 KL | Glass Lined Reactor, SS Reactor , Centrifuge |
| MPP-4 | 34.7 KL | Glass Lined Reactor, SS Reactor , high vacuum distillation, Centrifuge, ANFD, Tray Dryer, VTD, Multimill, Sifter, Blender |
| MPP-5 | 25 KL | Glass Lined Reactor, SS Reactor , Centrifuge, FBD, Multimill, Sifter, RCD |
| Small Volume Plant | 1.5 KL | Glass Lined Reactor, SS Reactor , high vacuum distillation Centrifuge, Tray Dryer, VTD, FBD, Multimill, Sifter, Blender |
Reaction Capabilities:
- Fermentation, Hydrogenation, Hydrochlorination, Acetylation, Hydrolysis, Basification, Condensation, Optical Resolution, Chiral Chemistry.
- Facility is available for development of new molecules, Technology transfer and scale up from R&D (Biotechnology/Synthetic) to pilot plant to commercial scale large and small volume
- Full-fledged effluent treatment facility is available for effluent management, our main strength is our Biodigestor, which generates Biogas from effluent,
- In-house facility for solvent recovery
- Purified water facility is available
Pharma Zone
The utilization of a gravity flow system in our finished product section ensures that there is minimal human handling of the final product. This system eliminates the scope for product contamination.
Controlled temperature and humidity conditions are maintained in the Pharma Zones. Our clean rooms are meeting ISO 8, Class 100,000 parameters.
The processing of the final product is done under controlled conditions of humidity and temperature.
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