API R&D Unit-II, Ankaleshwar
Gujarat, India
API R&D Unit-II, Ankaleshwar
Gujarat, IndiaOur API R&D Unit-II in Ankleshwar is a dedicated research and development facility that integrates advanced infrastructure, state-of-the-art laboratories, and pilot-scale capabilities to deliver cost-competitive, compliant, and scalable solutions. With 40 scientists, 10 engineers, five laboratories, and 21 fume hoods supporting up to 50 kg scale, the site is designed for handling complex molecules, advanced chemistries, and multi-step synthesis. Equipped with specialized instrumentation and strong analytical expertise, the facility enables pharmaceutical partners worldwide to accelerate development, strengthen regulatory submissions, and bring high-quality therapies to market with confidence.
API R&D Unit-II, Ankaleshwar
Gujarat, India
Capabilities
- Reactions across –78°C to +220°C
- Expertise in organometallic and advanced chemistries: n-Butyl Lithium, LDA, Suzuki coupling, Grignard, reductive amination, N/O-alkylation, Cope elimination, bromination
- Nano to semi-bulk scale equipment for process development
- Stereoselective synthesis using chiral auxiliaries and conventional reagents
- High-vacuum distillation (0.005 mm-Hg, <5 kg scale)
- Complex fractionation & falling film evaporation for semi-bulk distillation
- Variable-speed agitators with temperature control; design modifications for particle size and crystal habit optimization
- Dedicated pilot facility for scale-up
- Column chromatography
Production Capacity
- Research & Development (Block-III; Pilot plant)
- Located in Ankleshwar, GIDC (Asia’s largest chemical hub)
- Five laboratories and 21 fume hoods supporting API, CRAMs, CDMO, and intermediate R&D
- Conventional and advanced chemistries executed under DSIR-approved recognition (since 2011)
- Team strength: 22 synthetic chemists, 16 analysts (M.Sc., M.Pharm., Ph.D.), 11 engineers/chemists in TAD
- Routine support: CIP, troubleshooting, OOS/OOT investigations, market complaint resolution, vendor development for KSMs
- Process Development
- Scale-up to 50–500 g in R&D labs (process/high-pressure/autoclave)
- Pilot plant scale-up of 10–50 kg with dedicated equipment
- Manufacturing
- Reactor capacity: 100–750 L
- Intermediate and cleanroom facilities for scale-up and process validation to support USDMF, CEP, and other filings
| Sr. No. | Reactor | MOC | Capacity | Remarks |
|---|---|---|---|---|
| 1 | SSR-101 | SS 316 | 750 | Intermediate area |
| 2 | GLR-102 | SS 316 | 500 | |
| 3 | SSR-103 | SS 316 | 500 | |
| 4 | GLR-104 | CSGL | 250 | |
| 5 | GLR-107 | CSGL | 100 | |
| 6 | SSR-108 | SS 316 | 100 | |
| 7 | SSR-109 | SS 316 | 100 | |
| 8 | SSR-110 | SS 316 | 500 | |
| 9 | SSR-111 | SS 316 | 250 | |
| 10 | GLR-112 | CSGL | 250 | |
| 11 | SSR-105 | SS 316 | 250 | Clean Room |
| 12 | GLR-106 | CSGL | 250 |
Equipment & Utilities
- Mass spectrometry
- TQ system
- HPLC w/ TQ MS detectors
- HPLC
- HPLC with UV, PDA & RI detector
- HPLC with autosampler
- UPLC system
- GC
- GC with FID detector
- GCMS; GCHSMS
- GCHS
- Purification
- Column chromatography
- Crystallization
- NMR
- Support available from other Cohance sites
- Chemistry & Process
- Conventional laboratory reactions under inert atmosphere
- 1 L, 2 L & 5 L high-pressure autoclaves for hydrogenation and other applications
- Multiple fume hoods
- Analytical / QC
- HPLC/UPLC
- GC/GCHS
- GCHS MS
- Utilities
- HVAC
- Purified water systems
- Compressed gases
- Vacuum systems
- Electrical power & backups
- Waste handling systems
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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