Chloramphenicol Palmitate - Dc Msme

7Chloramphenicol PalmitatePRODUCT CODE : 33404QUALITY AND STANDARDS : As per standard of Indian PharmacopoeiaPRODUCTION CAPACITY : Quantity Rate (Rs.) Value (Rs.)8 MT 1150 92,00,000(per annum) (per kg.)MONTH AND YEAR : January, 2003OF PREPARATIONPREPARED BY : Small Industries Service InstituteIndustrial Development Colony Near ITI,Kunjpura Road, Karnal-132001, Haryana.Phone No. 2283882Fax No. 2283862E-mail : sisiknl@sancharnet.inINTRODUCTIONChloramphenicol is the specific drugfor control and cure of typhoid andbroad-spectrum bacterial diseases.Chloramphenicol finds extensive usethrough tablets and capsules whilechloramphenicol palmitate is used toformulate syrups. The structural formulafor chloramphenicol-palmitate isrepresented as:H NH COCHCI 2| |O 2N – C – C– CH 2OCO (CH 2) 14CH 3| |OH HIt lacks the bitter taste ofchloramphenicol. It is hydrolysed in theupper intestinal tract into the parentdrug, however, it does not share thetopical efficiency of the parent drug. Itstoxicity is like that of chloramphenicol.Chloramphenicol palmitate contains55.5-59.5% of chloramphenicol i.e.approx. 174 mg Chloramphenicolpalmitateis equivalent to 100 mgchloramphenicol. It is an anti-bacterialdrug and for an adult, the equivalent of1.5 to 3.0 g of chloramphenicol daily individed doses is required, for a child theequivalent of 25 to 50mg ofchloramphenicol per kg. of body weightdaily in divided doses is required.MARKET POTENTIALChloramphenicol is being producedboth in small scale and organized sector.At present in India there are a number ofunits registered with Secretariat ofIndustrial Assistance, Deptt. of IndustrialPromotion and Policy, Ministry ofCommerce and Industry, Government ofIndia, New Delhi. Export of Chloramphenicolhas shown increasing trend in recentyears. Looking into the demand ofChloramphenicol-palmitate and its export

40CHLORAMPHENICOL PALMITATEpotential, there is a good scope for settingup units in small scale sector.BASIS ANDPRESUMPTIONS1. The estimates are drawn for aproduction capacity generallyconsidered techno economicallyviable for a model type of manufacturingunit.2. The cost in respect of land andbuilding, machinery andequipment, raw materials and theselling prices of the Chloramphenicolpalmitate are thosegenerally obtained at the time ofpreparation of the project reportand may vary depending uponother various factors.3. The wages of the workers aretaken as per the prevailing labourwages laws.4. The plant, equipment andmachinery required for themanufacture of chloramphenicolpalmitateis either available or canbe fabricated indigenously basedon the designs, drawing andspecifications worked out for theproject.5. Interest rate for fixed and workingcapital has been taken at 14%.6. Scheme is worked out on twoshifts basis of eight hours a dayand 300 working days in a year.IMPLEMENTATION SCHEDULEPreparation of Project reportSelection of siteSSI registrationFinance/loan from bank orFinancial Institution1 month2 months1 month2 monthsPower connection/building 3 monthsconstructionMachinery procurement 3 monthsTrial run2 weeksActual Commercial Production 1 monthTECHNICAL ASPECTSProcess of ManufactureChloramphenicol is esterified bycondensing with palmitoyl chloride (CH 3(CH 2) 14COCI) in the presence ofpyridine. The crude ester is obtained bypouring the reaction product into a largeexcess of diluted Hydrochloric acid andthe whole mass is filtered. It is thenwashed with toluene dimethylformamide. The pure ester is dried,recrystallised and pulverized beforepacking. Chemical equation of thereaction is as under.H NH COCHCI 2| |O 2N – C – C– CH 2OH + CH 3(CH 2) 14COCl| |OH H ↓H NH COCHCI 2| |O 2N – C – C– CH 2OCO (CH 2) 14CH 3| |OH HQuality Control and StandardsChloramphenicol-palmitate is practicallyinsoluble in water, slightly soluble inalcohol, soluble in acetone, chloroformand solvent ether. It is fine white orgreyish white powder, it melts between87 0 to 95 0 C. It should conform to theStandard of Indian Pharmacopoeia.Production Capacity (per annum)Installed capacity : 8 MTValue : Rs. 92,00,000

CHLORAMPHENICOL PALMITATE41FINANCIAL ASPECTSA. Fixed Capital(i) Land and BuildingValue (Rs.)Land 1000 sq mtrs. @ Rs. 300 sq.mtr 3,00,000Building (Office, Store, working sheds, 3,50,000Boiler Room, Laboratory etc.Total 6,50,000(ii) Machinery and EquipmentsSl. Equipments Qty. ValueNo.(Rs.)1. Stainless steel reactors 2 3,00,000(500 litres capacity)equipped with a refluxcondenser and jacket forsteam heating.2. Air circulated steam heated 1 1,50,000coiled tray drier, with vacuumdrying system.3. Demineralised water plant 1 50,0004. Storage tanks for toluence/ 2 2,00,000dimethyl-formamide andHydrochlomic acid5. Boiler 1 1,00,0006. Filteration unit 1 1,00,0007. Pulveriser 1 50,0008. Laboratory equipments 2,50,000(Spectrophotometer, Thinlayer chromatographyCentrifuge, oven and otherlaboratory glassware andequipmentsTotal 12,00,0009. Erection charge @ 10% of 1.20,000the cost of machinery andequipments10. Office furniture and 20,000equipmentsPre-operative expenses 25,000(iii) Total Fixed CapitalTotal 13,65,000(Rs.)(13,65,000 + 6,50,000) = 20,15,000Working Capital (per month)(i) PersonnelSl. Designation No. Salary AmountNo.(Rs.)1. Chemist/Pharmacist 1 4,500 4,5002. Manager/commercial 1 3,400 3,400Assistant3. Analytical Chemist 1 2,500 2,5004. Sales Representative 2 3,000 6,0005 Accountant/ Clerk 2 2,000 4,0006 Skilled Workers 4 2,000 8,0007. Semi-skilled Workers 3 1,500 4,5008. Boiler Attendant 1 2,500 2,5009. Watchman and Peon 2 1,000 2,000Total 37400Perquisites @ 15% 5610Total 43,010or Say 43,000(ii) Raw Materials Including PackagingRequirement (per month)Particulars Ind./I/ Qty. Rate ValueImp. Kg. (Rs.) (Rs.)Chloramphenicol Ind. 405 1100 4,45,500Palmitoyl Chloride do 324 65 21,060Chemicals like do LS 30,000pyridine Toluene,dimethyl formamidePacking material LS 9,500Total 5,06,060or Say 5,06,100(iii) Utilities (per month)(Rs.)Electricity and fuel 30,000Water 1,000Total 31,000(iv) Other Expenses (per month) (Rs. )Postage and stationery 1,000Telephone 2,000Consumable stores 2,000Repairs and maintenance 1,500Transportation 2,500

42CHLORAMPHENICOL PALMITATEOther Expenses (per month) (Rs. )Advertisement and publicity 5,000Insurance 700Miscellaneous 2,000Total 16,700B. Working Capital (per month)1. Raw Material Rs. 5,06,1002. Salary and wages Rs. 43,0003. Utilities and other expenses Rs. 47,700Total Rs. 5,96,8004. Working Capital (for 3 Months)Rs. 17,90,400596,800 × 3 =C. Total Capital Investment(i) Working capital for 3 month Rs. 17,90,400(ii) Land and Building Rs. 6,50,000(iii) Machinery and Equipments Rs. 13,65,000FINANCIAL ANALYSISTotal Rs. 38,05,4001. Cost of Production (Rs)(i) Working capital for 1 year 71,61,600(ii) Depreciation on building @ 5% 17,500(iii) Depreciation on machineries and 1,20,000equipments @ 10%(iv) Depreciation on office furniture and 4,000equipments @ 20%(v) Interest on total Capital 5,32,756investment @ 14%Total 78,35,856Or say 78,36,0002. Sales Turnover (per annum)Item Qty. Rate Value(Rs) (Rs)Chloramphenicol- 8M.T. 1150 92,00,000palmitate3. Net Profit (per annum)Profit = Sale turnover – Cost of production= Rs. 92,00,000 – 78,36,000= Rs. 13,64,0004. Net Profit Ratio= Net profit per year × 100Sales turnover= 13,64,00 × 10092,00,000= 14.82%5. Rate of Return= Net profit per year × 100Capital investment= 13,64,00 × 10038,05,400= 35.84%6. Break-even Point(i) Fixed Cost (Rs.)(a) Depreciation on machinery and 1,20,000equipment(b) Insurance 8,400(c) Depreciation on building 17,500(d) Interest on total capital investment 5,32,756(e) 40% of other contingent expenses 76,800(f) 40% of salary and wages 2,06,400(ii) B.E.P.= Fixed cost × 100Fixed cost + Profit= 9611856 × 100961856+1364000= 41.3%Total 9,61,856Addresses of Machineryand Equipment Suppliers1. M/s. Chemical Plant andEquipmentsNaroda, GIDC,Ahmedabad, (Gujarat)2. M/s. Cadmach MachineryGIDC, Phase IV, Vatva,Ahmedabad.3. M/s.Sethi Engineering Works27/772, Zorawar Singh Marg,New Delhi.

CHLORAMPHENICOL PALMITATE434. M/s. Rank and Co.Wazirpur Industrial Area,New Delhi-110052.Addresses Raw Material Suppliers1. M/s. National Solvent CorporationDevi Dayal Road,Muland,Mumbai.2. M/s. Excel India Ltd.184-187 S.V Road,Jogeshwari,Mumbai.3. M/s. Cemet Ltd.214, Hans Bhawan,Wing No. 1,Bahadur Shah Zafar Marg,New Delhi.4. M/s. Manish Organic Ltd.National Chambers,Ashram Road,Ahmedabad.