Caplin Point Laboratories Limited, Unit – IV (CP-IV) is under construction for manufacturing of Pharmaceutical formulations in Specialized Injectable dosage forms, Ophthalmic drops, Ointments and Suppositories. The facility is designed with a high level of sophistication and automated process control and will be in compliance with norms stated by US FDA, UK MHRA and other regulatory bodies belonging to PIC/s.
The Site will have a dedicated facility for formulation development, analytical development and stability department for product development in sterile and non-sterile dosage forms.
CP-IV consist of 3 workshops being developed in phases, capable of handling general category injectable dosage forms and specialized category injectable dosage forms such as hormones and anabolic steroids with dedicated facilities to avoid any cross contamination and a third phase capable of manufacturing semi-solid dosages such as Ointments and Suppositories. The details of the 3 phases, all with individual containment capability, are:
Phase 1: Sterile liquid injection dosage form facility in the form of Ampoules, Vials, Pre-filled Syringes and Eye drops. The plant capacity is:
|1.||Ampoules ||20|| Million units per annum |
|2.||Vial||20||Million units per annum |
|3.||Pre-filled Syringes|| 3|| Million units per annum |
|4.||Eye Drops || 5||Million units per annum||
* Lyophilizer capacity is 10,000 vials per cycle of 10mL
Civil work for Phase 1 is close to completion. Facility will be ready for validation by Dec 2012 with commercial production set to start by May 2013.
Phase 2: Sterile specialized liquid injection dosage forms facility in the form of Ampoules and Vials with a provision to add Pre-filled Syringes and Eye drops. The plant capacity is:
|1.||Ampoule / Vial combi (1mL to 10mL)||20|| Million units per annum |
|2.||Vial (5mL to 100 mL)*||20||Million units per annum |
* Lyophilizer capacity is 25,000 vials per cycle of 10mL
The phase 2 civil work is expected to be completed and ready for validation by Sep 2013 with commercial production aimed at Dec 2013.
Phase 3: Semisolid dosage form facility for manufacturing of Ointments and suppositories. The plant capacity is:
|1.||Ointments (5gm to 25gm)||8|| Million units per annum |
|2.||Suppositories (1gm to 3gm)||8||Million units per annum |
The phase 3 civil work is expected to be completed and ready for validation by May 2014 with commercial production aimed at Sep 2014.
Dedicated engineering and utility departments have been setup to support services like Steam, Compressed Air, Nitrogen, Oxygen, Pharmaceutical Grade Water. Electricity with 100 % backup has also been planned to restore the power automatically with minimal interruption.
Upon completion of CP-IV project, Caplin Point will have the unique distinction of being one of the very few players in the Indian Pharmaceutical industry with US FDA (and other PIC/s) approved Specialized Injectable workshops.