FDF Unit-II, Jadcherla
Telangana, India
FDF Unit-II, Jadcherla
Telangana, IndiaOur FDF Unit-II, Jadcherla, is a pharmaceutical formulation intermediate (PFI) manufacturing site specializing in modified-release PFIs, including immediate-release, delayed-release, and sustained-release products. With robust capacity, advanced equipment, and reliable infrastructure, the site ensures consistent quality, scalability, and compliance for global markets.
Key Offerings: Pre Formulation Intermediates
Capabilities
- Multi-scale, multi-product PFI manufacturing with expertise in modified drug-release formulations.
Production Capacity
- Single product: 480 MT per annum (40 MT per month)
- Multi-product: 420 MT per annum (35 MT per month)
| Module | Key Equipment | Key Process | |
| Module - I | Conventional Coating Pan 48” | Pelletization | |
| Module - II | Conventional Coating Pan 60” | Pelletization | |
| Module - III | Fluid Bed Coater 150Kg × 4 Nos | Seal/Enteric/Sustained-release coating | |
| Module - IV | Fluid Bed Coater 500Kg | Seal/Enteric/Sustained-release coating | |
| Module - V | Fluid Bed Coaters 150Kg, 90Kg | Seal/Enteric/Sustained-release coating | |
| Module - VI | Fluid Bed Coater 750Kg | Seal/Enteric/Sustained-release coating | |
Equipment & Utilities
-
Key Production Equipment
- Conventional coating pans
- Pulverizers
- Tray dryers
- Blenders
- Fluid bed coaters
- Vibrosifters
- HPLC, GC, Dissolution apparatus
- Karl Fischer titrator, TOC analyzer
- Stability chambers
- Dedicated microbiology laboratory
- 21 HVAC systems meeting ISO Class D (90% recirculation, 10% fresh air)
- Boilers: 3 TPH with bio-briquettes as fuel
- Chillers: 250 TR and Cooling towers: 500 TR
- Purified water system: 1 KL generation capacity with 3 KL distribution tank (closed loop)
- Diesel generators: 500 KVA
- UPS
Accreditations & Certifications
- CDSCO
- DCA
- WHO GMP
- ISO 14001
- ISO 45001
Capabilities
Multi-scale cGMP intermediate & API manufacturing
Production Capacity
Total Reactor Volume: 406 KL
Annual Output Capacity: XXX MT
Block-wise Capacity:
| Block | Capacity | Key Features |
|---|---|---|
| Block A | 60 KL | Intermediate Manufacturing |
| Block B | 166 KL | API Manufacturing |
| Block C | 110 KL | High-Potency Handling |
| Block D | 10.5 KL | Pilot Scale Production |
Equipment & Utilities
Reactor Types
- Glass-lined
- Stainless Steel
Reactor Range
From [XX L] to [YY KL]
Key Equipment
- Centrifuges
- Dryers (ANFDs, Tray Dryers, RCVDs)
- Distillation Units
- Micronizers
Utilities Infrastructure
- HVAC Systems
- Boilers with backup power
- Chillers and Cooling Towers
- Purified Water and WFI Systems
- Nitrogen Generation Plant
- Reactor Types: Glass-lined, Stainless Steel
- Reactor Range: From [XX L] to [YY KL]
- Key Equipment:
- Centrifuges
- Dryers (ANFDs, Tray Dryers, RCVDs)
- Distillation Units
- Micronizers
- Utilities Infrastructure:
- HVAC Systems
- Boilers with backup power
- Chillers and Cooling Towers
- Purified Water and WFI Systems
- Nitrogen Generation Plant
Accreditation
History
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