Shilpa Medicare Limited
FDA Compliant • GMP Certified

cGMP Pilot Plant

From Concept to Commercial

Learn more about our cgmp pilot plant capabilities services and capabilities.

Immediate Release Tablets
Modified Release Systems
Oral Liquid Formulations
Sterile Injectables
Topical Preparations
Specialty Dosage Forms
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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 cGMP Facility

Our state-of-the-art cGMP pilot plant facility provides comprehensive manufacturing capabilities for pilot and clinical batches across multiple dosage forms. With dedicated areas for injectables, ophthalmics, and oral solid dosage forms (both potent and general), we offer flexible batch sizes and cost-effective solutions for your development needs.

Injectable Manufacturing Equipment

Equipment Name
Capacity
Manufacturing Vessel
• Gross volume 12 liter, working capacity 10 liter
• Gross volume 35 liter, working capacity 30 liter
Filtration Vessel
Gross volume 35 liter, working capacity 30 liter
Lyophilizer
Product chamber size: 1348mm(D) x 800mm(ID) = 677 L
HPHV Steam Sterilizer
Chamber size 900(w) x 900(h) x 1200(d) = 972 L
Terminal Sterilizer
• 5 ml vial per cycle: 1500 vials (rotating cart), 1610 vials (normal tray)
• 10 ml vial per cycle: 1000 vials (rotating cart), 1200 vials (normal tray)
• 100 ml vial: 250 vials (rotating cart)
Robotic Filling Machine
31 vials/min (Vial/PFS/Cartridge)
Vial Capping/Sealing Machine
31 vials/min (Vial/PFS/Cartridge)

Ophthalmic Manufacturing Equipment

Equipment Name
Capacity
Pressure Vessel Jacketed
• Gross volume 12 liter, working capacity 10 liter
• Gross volume 12 liter, working capacity 10 liter
• Gross volume 20 liter, working capacity 18 liter
• Gross volume 20 liter, working capacity 18 liter
• Gross volume 30 liter, working capacity 25 liter
• Gross volume 30 liter, working capacity 25 liter
Filtration Vessel 30L
Gross volume 35 liter, working capacity 30 liter
Movable LAF
Available as per requirement

Potent OSD Equipment

Equipment Name
Capacity
Integrated Granulation Line
HSG 10 L & 25 L
Roll Compactor
50 to 70 Kg/Hr
Tablet Coating Machine
18" and 24" coating pan
Capsule Filling Machine
6,360 Caps/hr
Tablet/Capsule Inspection
50,000 to 100,000 tabs/hr
Blister Packing Machine
• PVC pack: 25 cycles/min
• Alu-Alu pack: 20 cycles/min
Tablet Compression Machine
• Min: 4,800 tabs/hr
• Max: 14,400 tabs/hr

General OSD Equipment

Equipment Name
Capacity
Universal Blender
2 / 5 / 10 / 15 L
Cone Mill
10 kg/hr
High Shear Mixer Granulator
2 / 5 / 10 L
Vibrosifter
25 - 75 kg/hr
Fluid Bed Laboratory Unit
• For Drying & Top spray: 4.7 L
• For Wurster process: 2.4 L
Automatic Coating Machine
• Coating pan I: 0.5 - 1.0 kg
• Coating pan II: 3.0 - 5.0 kg
Hot Melt Extrusion
0.05 - 4.0 kg/hr
Blister Packing Machine
Capacity specifications available upon request
Tablet Compression
• Mono layer: 1,750 tabs/hr
• Bi-Layer: 750 tabs/hr
• Tri-Layer: 250 tabs/hr
Bottle Packing (Induction Sealing)
Available as per requirement
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