FDF Unit-IV, Shamshabad
Telangana, India
FDF Unit-IV, Shamshabad
Telangana, IndiaLocated in GMR Aviation SEZ near Hyderabad International Airport, our FDF Unit-IV, Shamshabad facility combines strategic accessibility with advanced pharmaceutical capabilities. With an installed capacity of 1.22 billion solid oral dosage units annually and state-of-the-art 21 CFR–compliant equipment, it is designed for efficiency, quality, and scalability. Supported by robust utilities, modern QC and microbiology laboratories, and a proven record of successful USFDA inspections, the site provides global partners with reliable manufacturing solutions, regulatory confidence, and ample scope for future expansion.
CDMO Unit-III, Pashamylaram
Telangana, India
Capabilities
- Pharmaceutical manufacturing, packaging, testing, and release of solid oral finished dosage forms (FDFs): tablets and capsules.
- Strategic location: situated in GMR Aviation SEZ, adjacent to Hyderabad International Airport, India.
- Future Expansion: Ample scope for capacity expansion and handling different Dosage Forms and new projects as per customer requirements.
Production Capacity
- Installed capacity: 1.22 billion units/year (tablets and capsules).
- Based on three-shift operations.
Manufacturing Equipment
- High Shear Mixers: 150 L & 800 L
- Fluid Bed Equipment (Drying, Top Spray, Bottom Spray): 250 L & 800 L
- Blenders: 100 L – 4000 L
- Compression Machines:
- Single Rotary: 12,000–96,000 tablets/hour (20 D Tooling) / 14,400–115,200 tablets / hour (24 B Tooling)
- Double Rotary: 58,800–470,000 tablets/hour (49 D), 73,200–585,000 tablets/hour (61 B)
- Auto Coaters: 125 L & 700 L
- Automatic Capsule Filling Machine (Can handle both Caplets, Powder and pellets): 40,000 capsules / hour, 90,000 Caps / Hour (Expected to be operational from Nov 2025)
- Bottle Packing Line (Optel make Serialization- Track and Trace): 60 BPM (Capacity approx. 1.0 Mio Units per day)

Utilities & Infrastructure
- HVAC System with multi-stage filtration: Pre (10µ), Fine (3µ / 5µ), Terminal HEPA (0.3µ, H14), Plenum HEPA (0.3µ, H13) – 38 AHU systems were installed for dedicated process areas. Can handle Controlled Temperature and Humidity requirements as per the product specifications.
- Air Compressors: 543 CFM & 40 CFM capacity
- Purified Water System: 2-pass RO + EDI, continuous recirculation, capacity 2000 LPH
- Boiler: Oil-fired, 3000 kg/hr
- Chillers: 400 TR
- DG Set: 1500 KVA
- Solar Power: 750 KW

Quality Control Laboratory
Equipped for Chemical Testing and Method validation (As per requirement) of raw materials, packaging materials, in-process and finished products.
Key Instruments:
- HPLC
- Headspace Gas Chromatography
- UV-Vis Spectrophotometer
- FTIR
- Polarimeter
- Auto Titrator
- TOC Analyzer
- Dissolution Apparatus
- Atomic Absorption Spectroscopy
Microbiology Laboratory
Capable of conducting microbial limit tests of raw materials, packaging materials, and in-process/finished products; environmental monitoring (active/passive air sampling); and purified water testing.Major Instruments:
- Autoclave
- Incubators
- Laminar airflow units
- Biosafety cabinet

Accreditations & Certifications
- US
- FDA
- WHO
- GMP,
- CDSCO
- DCA
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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