A State of the art manufacturing Facility
CTX Lifesciences has world-class manufacturing plants. Its Active Pharmaceutical Ingredient and intermediates manufacturing facilities established close to the city of Surat, is capable of handling complex and hazardous reactions. The manufacturing facilities comply with all Regulatory guidelines and requirements of current Good Manufacturing Practices (cGMP) and are successfully inspected/approved by international health and regulatory agencies.
Key features of the facilities include:
- Total area of site is 147,227.50 M2 of which the construction area is 56,919.91 M2
- More than Five production blocks covering API & Intermediates, and a mini-plant for scaling up of new products.
- Collective capacity of around 900 KL
- Kilo & Pilot Scale for Scaling & Launching New Products
- Capable of handling a broad ranges of reactions and broad range of process parameters.
- Facilities have been inspected by US FDA, EDQM, BfArM (Germany), TGA (Australia) and PMDA (Japan), Health Canada (USA) ANVISA ( Brazil) and Cofepris ( Mexico).
- The facility has been inspected by the USFDA 6 times (2009, 2012, 2016, 2018, 2019, 2022) and by EDQM in 2011, 2014, 2017 and 2022.
CTX Lifesciences has multiple storage areas and two defined Warehouses:
- Warehouse 1 : This is a ground plus three floor facility for storage of Raw Materials, Packaging Materials, Intermediate & APIs.
- Defined area of Receipt, Quarantine, Storage and Distribution for Raw Materials, Intermediate and API.
- Dedicated area for sampling and dispensing activities for Raw Material & APIs.
- Separate storage capabilities for storage of Enzymes, Catalysts & Hazardous Chemicals as per Safety norms.
- Storage capabilities of temperature under 2°C to 8°C and below Zero°C.
- Warehouse 2 : This warehouse is defined for Chemical Storage and other raw material used during production.
- Separate storage and distribution facility for solvents.
- Separate storage for engineering materials.
- Multiple fresh water surface reservoirs with a water treatment plant ensures an uninterrupted supply of water throughout the year.
- Independent generation and distribution system in each block.
- De-mineralization and Reverse Osmosis Techniques
- Each system is in a closed distribution loop through a dedicated storage tank under continuous circulation.
- In-built distribution loop sanitization with hot water