Kandla Factory

Formulation Manufacturing Plant:

The WHO-GMP facility is designed as per US-FDA guidelines and has approval from UK-MHRA, South Africa-MCC, Zimbabwe-MCAZ, and Sudan-MoH.

The total constructed area is divided into the following separate blocks

1. Tablet & General Capsules Manufacturing
2. Injection Manufacturing,
3. β - Lactum Capsules & Dry Syrup
4. QA / QC
5. Utility / Sec. Off. / Scrap Yard
6. WTP / ETP
7. Ware Houses
   

Located at a distannce of 792 kms to the North of Mumbai, the plant with an area of 28,930 sq. metres is located in the Kandla Special Economic Zone (previously Kandla Free Trade Zone). This unit will cater to the diverse need of Formulations like Tablets, Injections, Capsules & Dry syrup.

Plant-Salient Features

1. Layout to facilitate smooth movement of men & materials.
2. Manufacturing is on the ground floor and services are on the First Floor (Technical services floor) along with a dedicated service corridor for each areas to decrease contamination and improve functioning.
3. Separate air-handling system for individual section to prevent cross-contamination with 24 hour cooling system for all WIP and Quarantine areas.
   
4. The tablet manufacturing areas are supplied air, filtered through 0.3 micron
   HEPA filters to meet class 100000.
5. Full dust extraction system is incorporated.
6. Pressure gradients have been designed to ensure minimum contamination.
   a. All the service corridors are under negative pressure.
   b. All the manufacturing areas are under positive pressure.
   
7. All the critical areas are provided with electrical interlocks.
8. All the operations are planned for dust free transfers and there is no direct
   human contact anywhere to cause contamination.
   

The plant has well developed infrastructure, uninterrupted power supply, water supply, warehousing, skilled labour, and friendly administration. The plant is equipped to manufacture various general and specialized formulations, which comply with WHO-GMP, UK-MHRA, South Africa MCC, Zimbabwe-MCAZ norms and ISO 9000 norms. The center also specializes in projects for contract research, method development, DMF, DRF development and stability studies. It is currently working on the development of bulk active based on thebaine and formulation of eflornithine, a drug used for sleeping sickness.