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

The facility offers end-to-end CDMO services covering the development and scale-up of small molecule APIs and intermediates which are high potent in nature, with capabilities extending from route scouting to commercial manufacturing.
It has access to a comprehensive reaction toolbox comprising more than 25 reaction classes across diverse chemistries, enabling the development of robust and efficient synthetic processes.
The team possesses specialized expertise in handling high-potent compounds, including OEB-5 category molecules, with appropriate engineering controls and containment strategies.
With extensive experience, the unit is well positioned to accelerate 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

Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet

Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet

Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet

Lorem ipsum

Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet

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

Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet 

EHS

Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet 

Quality & Compliance

Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet 

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.

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna.
440
employees from around the world
+ 640
happy clients from largest corporations
+ 0
offices in 6 counties worldwide

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,

UI/UX Design
95%
App Development
82%
Business Growth
90%
Technology Solution
80%

Science & Technology

Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet Lorem ipsum dolor sit amet
John Smith A leading Company