API Unit-III, Ankaleshwar
Gujarat, India
API Unit-III, Ankaleshwar
Gujarat, IndiaOur API Unit-III, Ankleshwar, is an API and saleable intermediates manufacturing facility that combines advanced infrastructure, diverse reactor capabilities, and global regulatory accreditations to deliver reliable, scalable, and compliant solutions. With 101 reactors totaling about 426 m3 , specialized equipment, and robust utilities, the site is designed for flexibility, precision, and safety in handling complex molecules. Accredited by the USFDA, KFDA, EDQM, Cofepris Mexico, PMDA, ANVISA, ISO, and WHO, the facility enables pharmaceutical partners worldwide to accelerate development, scale seamlessly, and bring high-quality therapies to market with confidence.
Key Offerings: Generic APIs & intermediates manufacturing
Key Offerings: Generic APIs & intermediates manufacturing
API Unit-III, Ankaleshwar
Gujarat, India
Capabilities
- cGMP intermediate & API manufacturing
- Multi-scale cGMP saleable intermediates & API manufacturing
- Hydrogenation facility
- Cryogenic reactor facility
- O-alkylation, oxidation, hydrolysis, cryogenic, catalytic hydrogenation, epimerization & Cope elimination reaction handling capabilities
- High temperature reactions up to 150°C
- High-vacuum distillation up to 1 Torr
Production Capacity
Total Reactor Volume: 425.60 m3
Block-wise Capacity:
| Block | Total Volume in m3 / Capacity | |||||
|---|---|---|---|---|---|---|
| Block-I | Block-II | Block-III | Block-III | Block-IV | Block V | |
| 7.00 m3 | 138.00 m3 | 3.80 m3 | 3.80 m3 | 109.8 m3 | 167.00 m3 | 425.60 m3 |
Total Number of Reactors: 101
Equipment & Utilities
Reactor Types:
- Glass-lined
- Stainless Steel
- All-glass assemblies
- From 0.05 m3 to 8.0 m3
- Centrifuges / Nutsche Filters / Sparkler Filters
- Dryers (ANFDs, RCVDs, Vacuum Tray Dryers, Tray Dryers)
- Micronizers
- HVAC systems
- Boilers
- Chillers and Cooling Towers
- Purified Water Systems
- Nitrogen Generation Plants
- Diesel Generators
- UPS
- HPLC
- UPLC
- GC
- FT-IR
- Polarimeter
- Potentiometry
- Kirl Fisher Titrators
- Master Sizer 3000 for PSD
- pH Meters
- Moisture Analyser
- Stability Chambers
Accreditations & Certifications
- USFDA (Last audited in 2023)
- ANVISA (Last audited in 2024)
- PMDA (Last audited in 2023)
- Cofepris Mexico (Last audited in 2018)
- EDQM (Initial Audit in 2017)
- ISO 9001:2015
- WHO (FDCA & CDSCO)
- Other Regulatory Bodies (KFDA)
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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