Business Model › FDF
Finished Dosage Forms
Building on our legacy in high-quality API manufacturing, Harman has forward integrated into Finished Dosage Form development and manufacturing.
FINISHED DOSAGE FORMS
From API to FDF, Under One Roof
This forward integration uniquely positions us to deliver cost-effective, high-quality and timely solid oral dosage forms, combining in-house API production with formulation development and commercial manufacturing under complete quality control.
Formulation & Process Development
Regulatory Documentation & Global Dossier Support
Pilot & Commercial Batch Manufacturing
Technology Transfer & Scale-Up
Formulation & Process Development
Technology Transfer & Scale-Up
Pilot & Commercial Batch Manufacturing
Regulatory Documentation & Global Dossier Support
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APPROVED ANDAs
MULTIPLE PRODUCTS UNDER DEVELOPMENT
ORAL SOLID EXPERTISE
Every Oral Solid Dosage Form, Mastered
A QbD-driven development approach with First-to-File expertise across generic formulations.
Immediate Release
IR TABLETS
Conventional tablets developed for rapid, consistent drug release through wet granulation and direct compression.
Modified Release
MATRIX & RESERVOIR
Controlled and extended release systems engineered for precise, sustained therapeutic profiles.
Pellet Systems & DC Granules
FLUID-BED TECHNOLOGY
Multi-particulate pelletization scaling from 0.5 kg at lab level to 800 kg commercial batches.
Chewables & ODTs
ORALLY DISINTEGRATING
Patient-friendly formats designed to disintegrate rapidly, with no water required.
THERAPEUTIC FOCUS
- Diabetes
- Cardiovascular
- CNS
FDF MANUFACTURING FACILITY
World-Class Facility, at a Glance
Located in Shendra MIDC, Chhatrapati Sambhajinagar, ensuring seamless connectivity and logistics for commercial and clinical production.
3.25Bn
TABLETS ANNUALLY, EXPANDABLE TO 7 BILLION
4,000kg
MAX BATCH SIZE ACROSS PHASES I & II
30,149m²
TOTAL FACILITY AREA IN SHENDRA MIDC
100%
COSA-BASED TABLET INSPECTION
3.25Bn
TABLETS ANNUALLY, EXPANDABLE TO 7 BILLION
4,000kg
MAX BATCH SIZE ACROSS PHASES I & II
30,149m²
TOTAL FACILITY AREA IN SHENDRA MIDC
100%
COSA-BASED TABLET INSPECTION
Built for Global Standards
Designed to meet global regulatory requirements for commercial and clinical production.
Two Manufacturing Blocks
Small Batch Manufacturing (SBM) unit for small batches (11 kg to 33.5 kg) plus a large-scale facility, Phases I & II, supporting up to 4,000 kg batch sizes.
Automated High-Speed Lines
Fette compression, Glatt, Innojet & Bosch Hüttlin coating, Uhlmann blister packing, CVC and IMA bottle filling.
Vertical Gravity-Based Layout
Optimized material flow through the building, floor to floor.
Contactless Material Handling
Matcon systems with WIP handling for closed, contamination-free movement.
Track & Trace
Full serialization systems across packing lines.
100% tablet inspection
COSA-based inspection on every tablet.
FDF R&D
In-House R&D, Driving Innovation in Oral Solids
Our well-established R&D centre is equipped with advanced technologies to support all types of oral solid dosage forms, following a QbD-driven development approach with expertise in First-to-File projects and generic formulations.
1.5 L to 1450 L
High shear granulation systems, lab scale through commercial scale · Lab: 1.5L, 5L, 7L & 13L · Plant: 75L, 600L, 1400L & 1450L
2.5 L to 800 L
Pelletization systems (Hüttlin/Innojet), lab scale through commercial scale · Lab: 2.5L & 10L · Plant: 25L & 800L
3 L to 800 L
Bottom spray/Wurster systems (Glatt), lab scale through commercial scale · Lab: 3L · Plant: 250L & 800L
≤ 25 kg
Dedicated GMP pilot area for bio batches: tablets, capsules and pellets
Innojet · Glatt · Hüttlin
Advanced fluid-bed systems for pellet-based formulations
NEXT STEP
From Molecule to Finished Dose
From formulation development to commercial supply, one integrated partner from API to finished dose.
