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API R&D Unit-I, Genome Valley
Telangana, India
API R&D Unit-I, Genome Valley
Telangana, IndiaOur API R&D Unit-I, Genome Valley, focuses on innovative, non-infringing process research and development of pharmaceutical intermediates. The team specializes in managing complex chemistries and molecules to develop cost-competitive processes, drive continuous improvements, and support regulatory filings for new products in regulated markets. The facility also develops and validates analytical techniques for KSMs, intermediates, and APIs, and conducts carryover investigations for GTIs, nitrosamines, and NDSRIs in pharmaceutical ingredients. Equipped with state-of-the-art laboratories and advanced instrumentation, the site supports multi-step synthesis with precision and reliability.
Key Offerings: Process R&D, Analytical R&D
API R&D Unit-I, Genome Valley
Telangana, India
Processes
- Chemistry & Process:
- ANFD (SS) for filtration (5 L)
- Centrifuge for filtration
- Cylindrical all-glass reactors (2, 3 & 5 L) with variable-speed agitators
- Autoclaves (1 L and 2 L) for hydrogenation
- All-glass distillation column (5 L capacity)
- Analytical:
- HPLC with UV/PDA detectors
- GC, GC-HS
- GC-MS
- FT-IR
- Polarimeter
- Potentiometry
- Preparative HPLC
Capabilities
- Core Chemistry & Reaction Handling
- Reactions across temperatures ranging from –78°C to +220°C
- Equipment for process development from gram to 1 kg scale
- Handling of n-Butyl Lithium, LDA, Suzuki coupling
- Grignard reaction, reductive amination, N- & O-alkylation, bromination, Kumada coupling, Gomberg reaction, higher-scale cyanations
- Expertise in complex stereoselective synthesis using chiral auxiliaries and conventional reagents
- High-vacuum distillation (1 torr, <1 kg scale)
- Research & Development (Feasibility)
- API synthesis: mg to 500 g
- Intermediate synthesis: mg to 500 g
- Process Development
- Reaction handling and scale-up: 50–500 g (process/high-pressure lab; autoclave)
New Technologies-PFR
- 120 mL pinched tubular reactor with flow rate 1–100 mL
- 60 mL pinched spherical reactor with flow rate 1–100 mL
- Operating temperature: –60°C to 250°C
- Operating pressure: 0–40 bar
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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Quality & Compliance
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We deal With The Aspects Of Professional IT Services
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,
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 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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