Caplin Point Laboratories Limited, Unit – IV (CP-IV) is under planning, proposing to set-up general sterile liquid injection dosage form manufacturing facility in the form of Ampoules, Vials, Pre-filled Syringes and Eye drops catering to current and future the regulated markets such as North America, Mexico, Argentina & Brazil. Facility will comply to PIC/s and WHO GMP standards, ready for commercial production by April 2012.
Site will have dedicated facility for formulation development, analytical development and stability department for product development in sterile and non-sterile dosage forms.The planned 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 |
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CP-IV is designed with high level of sophistication and automated process control systems to meet regulatory and quality systems with a vision for at least a decade ahead.
Expecting to trigger the regulatory inspection by Q2 of 2012, with own development products and through site transfers. Sufficient land has also been available for future expansion in the same site for other dosage forms and specialty products.