API R&D Unit-III, Nacharam
Telangana, India
API R&D Unit-III, Nacharam
Telangana, IndiaAPI 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 |
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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Experience
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Sustainability
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About usEngitech 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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We’ll help you test bold new ideas while sharing your.
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