Learn more about our advanced formulation development facility services and capabilities.
API characterization, excipient compatibility and risk assessment.
Prototype formulation, optimization and robustness studies.
Pilot and validation batches with process optimization.
cGMP commercial manufacturing with in-house quality control and QA.
Service | Detail |
|---|---|
| Pre-formulation | Physicochemical characterisation, solubility and pKa profiling, drug-excipient compatibility, solid-state characterisation |
| Quality by Design development | Quality target product profile definition, critical quality attribute identification, risk assessment, design of experiments, design space definition, control strategy |
| Reverse engineering | Deformulation and characterisation of reference products; Q1/Q2/Q3 sameness assessment for generic topicals and complex products |
| Analytical development | Method development and validation to ICH Q2, stability-indicating methods, dissolution method development including biorelevant media and IVIVC |
| Extractables & leachables | Dedicated in-house E&L facility — study design, extraction, identification, quantification and toxicological risk assessment |
| Stability | ICH Q1A studies across climatic zones, photostability, in-use and transport simulation |
| Bioequivalence support | Study design, pilot and pivotal clinical batch manufacture, biowaiver justification, clinical site coordination |
| Bioanalysis | LC-MS/MS bioanalytical method development and validation; 20,000 samples per month; GLP-compliant pharmacokinetic support |
| Regulatory & IP | Regulatory strategy, patent landscape and freedom-to-operate evaluation, 505(b)(2) pathway assessment, CMC dossier authoring, agency query response |
| Technology transfer | Site-to-site transfer protocols, comparability, process validation, continued process verification |
Co-located with the oral dissolving film and transdermal manufacturing unit. Covers injectables, oral solids (oncology and non-oncology), transdermal and topical, ophthalmic and film dosage forms. Includes segregated potent and general suites, a GMP process development laboratory, a dedicated extractables and leachables facility, the nanotechnology research centre established in 2015, and pilot capability for bioequivalence and clinical batch manufacture.
Acquired by Shilpa Medicare in 2020. A contract research organisation focused on drug development, novel dosage forms, regulatory strategy, intellectual property evaluation and bioequivalence studies.
Approximately 40,000 sq ft across three floors. Analytical services and quality control laboratory, plus a bioanalytical laboratory with LC-MS/MS capacity of 20,000 samples per month and storage for more than 40,000 samples at −20°C and −70°C. Approvals include US FDA, EU-GMP, UK MHRA, ANVISA, CDSCO, NABL accreditation, GLP certification and DSIR recognition.
Seamless progression from lab to commercial scale
Systems designed for global regulatory standards
Cross-functional expertise for complete development
Comprehensive stability programs designed to support global regulatory submissions and product lifecycle management. Our facility houses state-of-the-art equipment supporting diverse formulation technologies and dosage forms
Comprehensive stability testing per ICH guidelines including long-term, short-term, and accelerated conditions with full statistical analysis and trending
Walk-in chambers with 5,700L (3 units) and 8,400L (2 units) capacity, all 21 CFR Part 11 compliant with validated monitoring systems
Specialized testing for light-sensitive formulations and packaging validation with ICH Q1B compliance
Stability programs for vials, prefilled syringes, transdermal patches, and other specialized forms with customized protocols
Equipment / Instrument Name | Equipment / Instrument Name |
|---|---|
| Lyophilizer | Blister packing machine |
| High pressure Homogeniser | Fluid Bed Processor |
| Ultra Sonicator | Pharma 11 tween screw extruder |
| Tangential flow filtration | Halogen moisture balance |
| Coatmaster | Bi-layer tablet press expert-2 |
| Tube sealing machine | Tablet Disintegration tester |
| Ointment/Gel manufacturing plant | Tablet Friability tester |
| ROPP Sealing machine | High shear Mixer granulator |
| Bag-on-Valve Aerosol Filler Machine | Universal Blender |
| Microcer Laboratory Agitator Mill | Rapid mix granulator R2T-10 |
| Roller compactor | Freeze Drying Microscopy |
| Autocoater-Chamunda | Manual capsule filling machine |
| Compressor machine-Iotapress-Chamunda | Tablet disintegration test apparatus |
| Manual capsule filling machine | Vibrosifter |
Shilpa Medicare has commercialised three complex or 505(b)(2) products with five more in development. Demonstrated programmes include Nor-ursodeoxycholic acid (world-first approval in NAFLD), an extended-release ondansetron injection with positive Phase 3 data, a rotigotine transdermal patch with EMA approval, rivaroxaban orodispersible films with EMA approval, a once-daily abiraterone presentation, and the world's first tranexamic acid haemostatic spray. If your molecule's value can be improved by a different route, a different release profile or a different presentation, this is the capability set that gets it to a filing.
