CONTRACT MANUFACTURING (CMO)
CONTRACT MANUFACTURING (CMO)
WORLD-CLASS USFDA & EU GMP COMPLIANT STERILE AND
NON-STERILE ONCOLOGY
PRODUCT MANUFACTURING
- Sterile and Non-sterile formulation products manufacturing at world class facility for Oncology, Hormones & High Potent products
- Aseptic processing under Isolator and CRAB technology integrated with BOSCH Filling line with an operating capacity of 10 ‘million Vials & PFS per annum with a filling range from mito 50 mi vial sizes.
- Lyophilisation using Martin Christ Lyophiliser with an automated loading and unloading of vials under Isolator
- Oral Solids processing under isolator containment equipped with GEA granulation line, compression machine, LB Bohle Coating machine, MG2 Capsule filling machine and CVC Bottle Packing line with an annual operating capacity of 180 million tablet and capsules.
CONTRACT RESEARCH (CRO)
RESEARCH & DEVELOPMENT OF DRUG FORMULATIONS, WITH CGMP COMPLIANT PILOT MANUFACTURING FACILITY FOR CLINICAL/ INVESTIGATIONAL INJECTABLE & ORAL SOLIDS®
- RD expertise in latest Pharmaceutical development design approach applying “Quality-by-Design” principles, ensuring design efforts translate into amore successful product development, scale-up, EB execution, and global regulatory submissions.
- State-of-the-art RD facility With extensive knowledge & experience in development of multiple contract forms comprising Tablots, Capsules, Injectable (Liquid, Lyophilized, PFS, Complex Injectable, Semisolid formulations).
- Collective expertise of existing R &D personnel handling drug design and development for highly regulated markets like USA, Europe, UK, Australia, Canada and other geographies, on over 300 formulations right from concept to regulatory filing and approval, hands on experience in developing F2F, Para WV and Non-infringing formulations.
MANUFACTURING CAPACITIES
Block B (Production Oncology)
The Large capacity manufacturing facility consists of both Injectable and OSD formulations, suitable for higher batch size.
Dosage form Installed capacity per annum
- Tablets ~ 50 Million
- Capsules ~ 50 Million
- Injections
Vials filling ~ 3 Million
Vials lyophilization ~ 2.5 Million
| Building | Area Description | Area |
|---|---|---|
| Block - A
(Total built-up area: 2023.48 m2) |
Ground floor - Warehouse, Dispensing, QC, Analytical development Lab | 552.36 m2 |
| First floor - Manufacturing (Injectable & OSD section) | 677.0 m2 | |
| Second Floor-Formulation Development | 677.0 m2 | |
| Third Floor – Water system, Utility& Stability Area. | 117.12 m2 | |
| Block - B
(Total built-up area: 10645.16 m2) |
Ground floor - Warehouse, Manufacturing (Injectable & OSD section) | 4699.0 m2 |
| Mezzanine floor – Quality Assurance, Administration, Conference hall, Regulatory Affairs, Visitors dining, Technical area. |
702.0 m2 | |
| First floor - QC Chemical & Microbiology Laboratory | 4699.0 m2 | |
| Second floor - Utilities | 545.16 m2 |
MANUFACTURING EQUIPMENTS
Block B (Oncology Manufacturing Facility)
| Name of the equipment | Make | Capcity |
|---|---|---|
| Injectable section
|
||
| Compounding & filtration vessel | Propac, India | 50L & 200L |
| Integrated Vial Filling line | Bosch, Germany | 120 vials per min |
| Lyophilizer | Martin Christ, Germany | 10 sq mts. (20000 vials - 10ml 24mm dia) |
| Autoclave | Fedegari, Germany | 1075 lts. |
| OSD section (Oncology) | ||
| Integrated Granulation line | GEA, Germany | 4.5 Kg to 36 Kg |
| Integrated Single pot processor | Bosch, Germany | 11.25 Kg to 26.25 Kg |
| Bin Blender | GEA, Germany | 15 Kg to 35 Kg |
| Compression machine | GEA, Germany | 21 station / 60 RPM / 75600 tablets / hr |
| Capsule filling machine | MG2, France | 70000 Capsules / hour |
| Coating machine | LB BOLHE, Germany | 3 Pans (10L, 25L and 50L) / 5Kg to 30Kg |
| Packing section | ||
| Bottle packing machine | CVC, Taiwan | 2400 bottles / hour |
| Blister packing machine | Elmach, India | 1500 blisters / hour |
| Labeling machine | CVC, Taiwan | 15000 units / hour |