Services
CRO / CRAMS / CDMO
Contract research and manufacturing across the drug discovery pipeline - from target identification through to clinical trial supply.
What we supply
- API-Intermediates
- Reference Compounds
- Metabolites Compounds
- Impurities
- Degradation Studies
- Stable Label
- NCE Scale-ups
Discovery pipeline
Support at every stage
We provide synthetic and analytical support across the full discovery and development sequence.
- 1Target ID and Validation
- 2Hit ID and Optimization
- 3Lead Optimization
- 4Candidate Selection
- 5Candidate Profiling
- 6Clinical Trials
Introduction of functional groups of dropped NCEs; synthesis of competitors' EDC, NCE, ECN and candidates.
Library, poly peptides, un-natural amino acids and paid linkers.
Identification of pharmacophores from various literature sources, such as patents, publications and ACS journals.
Synthesis of compounds through non-conventional sources - organo-metallic catalysts, from VIBGYOR to the visible region (photochemistry).
Quality policy
We are committed to Quality and hence we have a robust Quality Management System in accordance with ISO, cGMP, ICH and other regulatory and statutory guidelines.
Quality Assurance
- Product data review & release.
- Documentation control & implementation.
- Approval of quality related documents including change control.
- Approval of all the documents related to validation & qualification.
- Rework, reprocess, returned goods control.
- OOS & market complaint investigation.
- Annual Product Quality Review.
- SOP training & implementation.
- In-process and retrospective audits.
- Trainings on safety & other aspects at the plant.
Quality Control
- Sampling, testing and release of raw material, in-process, intermediates and final products.
- Lab management & GLP.
- QC instrument calibration.
- OOS investigation - laboratory testing.
- Control sample management.
- Hold time stability.
Manufacturing
Plant equipment & utilities
Reactor capacity, analytical instrumentation and site utilities across our manufacturing units.
Plant equipment
| Equipment | No. of units |
|---|---|
| GLRs | 37 |
| SSR | 52 |
| Centrifuge | 22 |
| Hydrogenators | 7 |
| High vacuum distillations | 9 |
| Driers (Tray / Vacuum / FBD / ANFD) | 37 |
| Others… | - |
Plant analytical instruments
| Instrument | Make | Units |
|---|---|---|
| HPLC | Shimadzu (2), Thermo (2), Waters (1), Youngling (1), Agilent (2) | 8 |
| GC | Shimadzu (2), Thermo (1), Youngling (1), Agilent (1) | 5 |
| Other essential instruments… | - | - |
Plant utilities
| Equipment & no. of units | Specification |
|---|---|
| Boiler (3) | 4.0 Tons/Hr (2) & 2.0 Tons/Hr |
| Brine Compressor (6) | Varying capacities, up to −20 °C |
| Uninterrupted HT Power Line | For both units |
| Diesel Generator (5) | 320 KVA, 500 KVA, 750 KVA & 1010 KVA |
| Multiple effective evaporation System (2) | 40 KLD at each plant |
| RO Water system (2) | 5 KL/Hr. |
| Others… | - |
Work with us
Discuss a contract research programme
Tell us the compound, the stage and the timeline. We will come back on feasibility and route options.