Shilpa Medicare Limited
FDA Compliant • GMP Certified

Formulation Development

From Concept to Commercial

Learn more about our advanced formulation development facility services and capabilities.

Immediate Release Tablets
Modified Release Systems
Oral Liquid Formulations
Sterile Injectables
Topical Preparations
Specialty Dosage Forms
Formulation Development
500+
Formulations Developed
15+
Dosage Forms

Our Formulation Development Process

Pre-formulation

API characterization, excipient compatibility and risk assessment.

Development

Prototype formulation, optimization and robustness studies.

Scale-up

Pilot and validation batches with process optimization.

Manufacturing

cGMP commercial manufacturing with in-house quality control and QA.

State-of-the-Art Development Facility

Our Formulation R&D facility is fully equipped for comprehensive drug development from lab scale (1/100) through scale-up (1/10) to full production at our Jadcherla facility. With systems designed to meet global statutory and regulatory requirements, we deliver excellence in pharmaceutical formulation development.

Core Development Capabilities

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Scale-Up Excellence

Seamless progression from lab to commercial scale

Regulatory Compliance

Systems designed for global regulatory standards

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Integrated Support

Cross-functional expertise for complete development

Stability Testing Capabilities

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

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ICH-Compliant Studies

Comprehensive stability testing per ICH guidelines including long-term, short-term, and accelerated conditions with full statistical analysis and trending

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Advanced Chambers

Walk-in chambers with 5,700L (3 units) and 8,400L (2 units) capacity, all 21 CFR Part 11 compliant with validated monitoring systems

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Photostability Testing

Specialized testing for light-sensitive formulations and packaging validation with ICH Q1B compliance

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Diverse Dosage Forms

Stability programs for vials, prefilled syringes, transdermal patches, and other specialized forms with customized protocols

Equipment Inventory

Equipment / Instrument Name
Equipment / Instrument Name
LyophilizerBlister packing machine
High pressure HomogeniserFluid Bed Processor
Ultra SonicatorPharma 11 tween screw extruder
Tangential flow filtrationHalogen moisture balance
CoatmasterBi-layer tablet press expert-2
Tube sealing machineTablet Disintegration tester
Ointment/Gel manufacturing plantTablet Friability tester
ROPP Sealing machineHigh shear Mixer granulator
Bag-on-Valve Aerosol Filler MachineUniversal Blender
Microcer Laboratory Agitator MillRapid mix granulator R2T-10
Roller compactorFreeze Drying Microscopy
Autocoater-ChamundaManual capsule filling machine
Compressor machine-Iotapress-ChamundaTablet disintegration test apparatus
Manual capsule filling machineVibrosifter
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