FDF Unit-IV, Shamshabad

Telangana, India

FDF Unit-IV, Shamshabad

Telangana, India
Located 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
Total Number of Reactors: 89

Equipment & Utilities

Reactor Types
  • Glass-lined
  • Stainless Steel

From [XX L] to [YY KL]

  • Centrifuges
  • Dryers (ANFDs, Tray Dryers, RCVDs)
  • Distillation Units
  • Micronizers
  • 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

History

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Experience

Our great team of more than 1400 software experts.

Quick Support

We’ll help you test bold new ideas while sharing your.

Leadership Team

John Smith
CEO
Emma London
Co-Founder
Jessica Brown
Managing Director
Christine Eve
Designer

Sustainability

ESG

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Quality & Compliance

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We deal With The Aspects Of Professional IT Services

About us

Engitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,

Experience

Our great team of more than 1400 software experts.

Quick Support

We’ll help you test bold new ideas while sharing your.

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We deal With The Aspects Of Professional IT Services

About us

Engitech is the partner of choice for many of the world’s leading enterprises, SMEs and technology challengers. We help businesses elevate their value through custom software development, product design,

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