API Unit-IV, Nacharam (CDMO Wing)
Telangana, India
API Unit-IV, Nacharam (CDMO Wing)
Telangana, IndiaOur API Unit-IV, Nacharam (CDMO Wing) is a hi-potent API and intermediate manufacturing facility that combines advanced infrastructure, diverse reactor capabilities, and global regulatory accreditations to deliver reliable, scalable, and compliant solutions. With 63 reactors totaling 36.84 KL, specialized equipment, and robust utilities, the site is designed for flexibility, precision, and safety in handling complex, high-potency molecules. Accredited by the USFDA, EDQM, ISO, and WHO, the facility enables pharmaceutical partners worldwide to accelerate development, scale seamlessly, and bring high-quality therapies to market with confidence.
API Unit-IV, Nacharam (CDMO Wing)
Telangana, India
Capabilities
Multi-scale cGMP hi-potent intermediate & API manufacturing
Production Capacity
- Total Reactor Volume: 36.84 KL
- Block-wise Capacity:
| Block | Total volume in KL/Capacity |
|---|---|
| PB-01 | 9.8 KL |
| PB-02 | 2.92 KL |
| PB-03 | 1.53 KL |
| PB-04 | 3.2 KL |
| PB-04A | 0.66 KL |
| PB-04B | 0.45 KL |
| PB-05 | 0.713 KL |
| PB-06A | 3.95 |
| PB-06B | 8.1 KL |
| PB-06C | 0.06 KL |
| PB-07 | 2.13 KL |
| PB-08 | 3.33 KL |
| Total | 36.84 KL |
Equipment & Utilities
- Reactor Types: Glass-lined, Stainless Steel, and All-glass assemblies
- Reactor Range: From 0.02 KL to 2 KL
- Key Equipment:
- Centrifuges
- Dryers (ANFDs, Tray Dryers, RCVDs)
- Distillation Units
- Micronizers
- Utilities Infrastructure:
- HVAC Systems
- Boilers
- Chillers and Cooling Towers
- Purified Water System
- Nitrogen Generation Plant
- Diesel Generators
- UPS
Accreditation
- USFDA (Last audited in 2025)
- EDQM (Initial Audit in 2024)
- ISO 9001:2015
- Other Regulatory Bodies (WHO and WHO GMP)
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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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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Our great team of more than 1400 software experts.
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We’ll help you test bold new ideas while sharing your.
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