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MAJOR PRODUCT CATEGORY
KAPL offers a comprehensive range of life saving dosage forms:
(Pharma and Veterinary)
| v | NON–PARENTERAL ANTIBIOTICS & OTHERS. |
PARENTERAL PRODUCTION – KEY FACILITIES
DRY POWDER PARENTERAL PLANT [ DPP – I ]
A separate dedicated plant for ß-lactam [Penicillin] injectables like Benzyl Penicillin, Ampicillin Sodium, Benzathine Penicillin, Fortified Procaine Penicillin etc.
DRY POWDER PARENTERAL BLOCK [ DPP – II ]
For manufacturing Non ß-lactam & Cephalosporin injectables.
SMALL VOLUME PARENTERAL [ SVP ]
For manufacturing liquid injectables of 2 ml vials to 100 ml vials & ampoules of 1 ml to 10 ml.
ß-LACTAM INJECTABLE FACILITY – Salient Features:
| v | High tech, automated aseptic continuous production line capable of handling multi products, multi dosages to the highest accuracy and with least human intervention. |
| v | Vial washing, sterilization and cooling system: Gilowy, Germany – Capacity, 240 vials per minute. |
| v | Line capacity – 80,000 vials per shift of 8 hours. |
| v | Class 100 up to sealing. |
| v | Separate classified area 10,000 for sealing process under class 100 LAF. |
| v | Mezzanine at the top with all the services of utilities with separate AHUs. |
| v | Loop system for de-mineralized water and water for injection. |
| v | Automatic filling and stoppering operation without manual handling. |
| v | Automatic Sticker Labeling Machine – 120 vials / minute. |
NON ß-LACTAM INJECTABLES MANUFACTURING FACILITY: 
| v | Filling and stoppering automatic equipment from “Perry” USA. |
| v | Filling, stoppering under class 100. |
| v | Continuous line, starting from filling to packing. |
| v | Capacity 50,000 vials per shift of 8 hours. |
SMALL VOLUME PARENTERALS:
| v | 50,000 vials (2 ml) per two shifts / day. |
| v | 50,000 ampoules (2 ml to 3 ml) per two shifts / day. |
| v | Classified area 100 for filling and stoppering in sterile area. |
| v | Mezzanine at the top with services and AHU’s. |
| v | CGMP design / model for WFI plant with 500 litre / hour capacity. |
NON-PARENTERAL KEY FACILITY:
TABLETS:
| v | Facility for Film coating, Enteric coating, Blister packing & Aluminium strip packing. |
| v | Machines / equipments for manufacturing tablets from 6 mm to 13 mm, Capacity 10 lakhs per shift. |
| v | Machines / equipments for large tablets / bolus upto 6 gram weight. |
CAPSULES:
| v | Separate area for ß-lactam & Non-ß-lactam capsules dosage forms. |
| v | 10 lakh capsules per two shifts, size ‘2’ to size ‘0’. |
LIQUID ORALS & DRY SYRUP, SACHETS & POWDERS:
| v | Facility for liquid syrup & suspension from 30 ml bottle to 5 litre container. |
| v | Facility for dry syrup bottles 30 to 100 ml. |
| v | Facility for powders in sachets, containers, 20 gm to 5 kg. |
 QUALITY ASSURANCE FACILITY:
| v | Separate area for Chemical, Pharmacological, Microbiological, instrumental analysis. |
| v | Separate classified 100 area with HVAC for sterility testing. |
| v | Separate instrument room with sophisticated latest analytical instruments like HPLC, IR, GC etc. |
| v | Qualified & trained analyst & Microbiologist. |
RM & PM STORE:
| v | Segregation of RM & PM as per CGMP requirements. |
| v | Receipt / Issues / Approval / Rejection through Integrated Information System. |
| v | Cool room for storing antibiotics, capsules etc. |
| v | Classified area for dispensing of RM for oral dosage form. |
 KEY QUALITY ASSURANCE SYSTEMS FOLLOWED
| v | In house testing as per international specifications. |
| v | Area / filters validations. |
| v | Aseptic filling process validation by broth fill trials. Protocol includes simulation trials for intrusions / interruptions. |
| v | Water system validation [ DM & WFI ]. |
| v | Medical Health Monitoring. |
| v | Stability studies as per ICH guidelines for selected products. |
| v | Analytical method validation as per ICH guidelines. |
| v | Hold time for sterilized components – validation. |
| v | Equipment cleaning validation – product change over etc. |
| v | Routine biological control [ Water, clean rooms and other manufacturing areas]. |
| v | Effective handling of Market complaints. |
Factory / Plant Workforce:
Manufacturing:
| v | Skilled & Trained Operators - 147 |
Quality Assurance:
Formulation & Development:
Engineering & Projects:
KAPL HAS BEEN MANUFACTURING PRODUCTS FOR REPUTED INDIAN AND MULTINATIONAL COMPANIES.
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