API R&D Unit-III, Nacharam

Telangana, India
API R&D Unit-III, Nacharam

API R&D Unit-III, Nacharam

Telangana, India

API R&D Unit-III, Nacharam spans ~10,000 sq. ft. and offers end-to-end CDMO services for high-potent Payloads, APIs, and intermediates, supporting delivering integrated solutions from discovery to commercial manufacturing.

The team has deep expertise in developing validated processes for OEB-5 category compounds involving complex chemistries. The site also supports regulatory submissions for new products in regulated markets and develops as well as validates analytical methods for KSMs, intermediates, and APIs. In addition, the facility conducts carry-over investigations for GTIs, nitrosamines, and NDSRIs in pharmaceutical ingredients.

With a strong team of over 65 scientists, and more than 20 years of CDMO experience, the unit brings two decades of proven expertise in translating chemistry from lab-scale innovation to early-phase development, scale-up, and commercial manufacturing.

API R&D Unit-III, Nacharam

Telangana, India

Capabilities

End-to-end CDMO services covering development and scale-up of small-molecule APIs and intermediates, especially high-potency molecules — from route scouting to commercial manufacturing.
Comprehensive reaction toolbox with 25+ reaction classes across diverse chemistries, enabling robust and efficient synthetic process development.
Specialized expertise in handling high-potent compounds, including OEB-5 category molecules, supported by advanced engineering controls and containment strategies.
Strong experience in accelerating chemical process development, ensuring smooth technology transfer from laboratory scale to pilot and commercial manufacturing facilities.

Production Capacity

  • Early-phase to commercial-scale synthesis of HPAPIs
  • Capability to support mg-to-kg scale-up

Research & Development

  • 65+ scientists with deep expertise in small molecule development
  • 20+ years of experience with cutting-edge process innovation
  • Collaborative development for NCE programs: from lab to commercial scale

Equipment & Utilities

  • Chemistry & Process
  • Cylindrical all-glass reactors (1, 3 & 5 L) with variable-speed agitators
  • Autoclaves (750mL & 2 L) for hydrogenation
  • Small filtration set up, ANFD (SS) and Centrifuges
  • Analytical
  • HPLC with UV/PDA detectors
  • GC, GC-HS
  • ICP-OES
  • NMR- 400 MHz
  • LC-MS
  • GC-MS
  • Potentiometry
  • Preparative HPLC

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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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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