Detailed Project Report on pharmaceutical manufacturing plant (oncology drugs manufacturing & packaging, injectable drugs manufacturing & packaging, i.v. fluids, tablet, capsules, syrups, ointments etc.)

PHARMACEUTICAL MANUFACTURING PLANT (ONCOLOGY DRUGS MANUFACTURING & PACKAGING, INJECTABLE DRUGS MANUFACTURING & PACKAGING, I.V. FLUIDS, TABLET, CAPSULES, SYRUPS, OINTMENTS ETC.)
[CODE NO.3478]  


The foundation of the modern Indian pharmaceutical Industry was laid at the start of the current century when in 1901, a small factory known as the Bengal Chemical & Pharmaceutical works was established in Kolkata. Though the two world Wars gave a Phillip to the development of industry, the progress made under British rule was not significant except the British introduced into this country the allopathic system of medicine. The country depended largely for its requirements on U.K., France and Germany.

The development of Indian Drugs and pharmaceuticals Industry was not commonsurate with the size of this country and the growing needs of people, when Indian embarked on its planned economic expansion industry has been substantial and many sides with the result that it has becomes one of the leading industries. India is now producing a larger quantity of varied pharmaceuticals products.

Prior to the launching of the second plan the manufacture of pharmaceuticals was limited largely to the processing of bulk imported drugs into tablets, capsules and other formulations. Indian firms under agreement with foreign firms are making injectables, powders ointments and liquids, and were also filling antibiotics. Certain units were producing biological extracts, vacines, and syrup. Alkalods, like quinins stry-chinea, caffeine, and morphine were also being extracted. It was however obvious that the country could not forever be dependent on foreign manufacturers for both finished drugs and basis raw materials. With the changing political climate, pharmaceutical manufacturers in India were encouraged to take up the manufacture of basis drugs wherever it was economically possible and technically feasible.

A system of collaboration was instituted, under which Indian manufacturers in association with established firms in U.S.A., Italy, U.K. began to produce a fairly comprehensive range of basic items. While the allocation of foreign exchange for the import of raw materials and basic intermediates for the production  of drugs, has been more or less static the  value  of products  manufactured has increased progressively  several  fold clearly  indicating  the  growing stature, of  industry and its capacity to switching over to basic raw materials and  components of  indigenous origin, and now the country is stated  to  achieve self,  sufficiency in synthetic drugs of the sulpha group, anti T.B. drugs, Vitamins, and intermediates.

It has, however, been found that the present installed capacity is insufficient to meet the over growing demand of the massive population and the scope for new units to come up is substantial.

Intra venous fluids, in general are used as I.V drips for patients in nursing homes and hospitals suffering from acute dehydration or considerable debilitating conditions.  These I.V fluids replanish the body fluids. Though a number of I.V fluids are there, generally three types of I.V fluids are used in hospitals as I.V drips. They are as follows:-

  1. Dextrose injection fluid

  2. Dextrose and sodium chloride injection fluid


COST ESTIMATION

Plant  Capacity                                          :       PHARMACEUTICAL MANUFACTURING PLANT                      
land & Building  (20000 Sq.Mtr)             :    Rs. 20.19 Cr
Plant & Machinery                                      :    Rs. 19.20 Cr
Working Capital for 2 Months                   :    Rs. 10.19 Cr
Total Capital Investment                            :    Rs. 50.28 Cr
Rate of Return                                             :    66%
Break Even Point                                         :    30%


INTRODUCTION    
PARENTAL PRODUCTS (INJECTABLES)    
INJECTION    
ARSENIC    
MODE OF ADMINISTRATION OF INJECTABLES    
EYE DROPS    
OXYTOCIN INJECTION (PITUITARY)    
PROPERTIES & CHARACTERISTICS OF INJECTION (DISTILLED WATER)    
CHARACTERISTICS OF INJECTABLES     
PROPERTIES OF OPHTHALMIC PREPARATION    
(EYE DROPS)    
1. STERILITY     
2. TONOMICITY     
SURFACE ACTIVITY     
CLARITY    
VISCOSITY     
OXYTOCIN INJECTION (PITUITARY)    
USES AND APPLICATIONS    
ADVANTAGES OF PARENTERAL PRODUCTS (INJECTABLES)     
OXYTOCIN INJECTION (PITUITARY)
B.I.S. SPECIFICATION    
RAW MATERIALS FOR INJECTION DISTILLED WATER    
GLASS AMPOULES    
TYPES OF I.V. FLUID    
COMMONLY USED I.V. FLUIDS    
HOW INTRAVENOUS FLUIDS ARE CREATED    
DEXTROSE SALINE INJECTION    
MARKET SURVEY    
MARKET SIZE    
MARKET STRUCTURE    
INVESTMENTS    
GOVERNMENT INITIATIVES    
ROAD AHEAD    
INCREASING INVESTMENTS IN THE SECTOR    
DETAILED EXPORT DATA OF PHARMA PRODUCT PHARMACEUTICAL    
OVERVIEW OF THE INTRAVENOUS SOLUTIONS MARKET    
GEOGRAPHICAL SEGMENTATION OF THE INTRAVENOUS SOLUTIONS
   MARKET    
COMPETITIVE LANDSCAPE AND KEY VENDORS    
KEY VENDORS IN THIS MARKET ARE -    
GROWTH DRIVERS, CHALLENGES, AND UPCOMING TRENDS HOME TREATMENT    
ONCOLOGY DRUG MARKET IN INDIA    
FINDINGS FROM A STUDY CONCLUDED THE CANCER SCENARIO
   IN INDIA THAT    
MARKET SIZE    
STRENGTHS    
WEAKNESS    
OPPORTUNITIES    
MARKET DRIVERS    
INDUSTRY CHALLENGES    
GLOBAL CANCER DRUGS MARKET    
ONCOLOGY- A BOOMING BUSINESS    
LATEST DEVELOPMENTS IN INDIAN ONCOLOGY SPACE    
NEW ENTRANTS IN THE INDIAN ONCOLOGY MARKET    
MANUFACTURER OF PHARMACEUTICAL PRODUCTS    
GLOBAL ONCOLOGY MARKET AND PROCESS SOLUTION    
ONCOLOGY AND ITS TREATMENT    
CHEMOTHERAPY    
GENERIC DRUGS IN ONCLOGY    
USES AND APPLICATION OF I.V. FLUIDS    
MANUFACTURING PROCESS OF INJECTION WATER    
FILLING OF AMPOULES    
PROCESS FLOW CHART    
PROCESSING OF PARENTRAL PRODUCTS INJECTIONS    
TECHNIQUES INVOLVED IN THE PREPARATION OF INJECTABLES    
PACKING OF PARENTERAL PRODUCTS (PACKING OF INJECTABLES)    
PROCESSING OF CONTAINES & CLOSURES    
EVALUATION OF PARENTERAL PRODUCTS    
A. STERILITY TEST    
PYROGEN TEST    
CLARITY TESTS    
LEAKAGE TESTS    
FLOW DIAGRAM FOR PREPARATION OF INJECTABLES    
PREPRATION OF EYE DROPS    
FLOW DIAGRAM FOR PREPARATION OF EYE DROPS    
MANUFACTURING PROCESS FOR OXYTOCIN INJECTION (PITUITARY)    
THEORY    93
RAW MATERIAL REQUIRED    
MANUFACTURING PROCESS    
PROCESS FLOW SHEET FOR OXYTOCIN INJECTION (PITUITARY)    
FORMULATIONS OF TABLETS    95
1.   TABLETS FOR FATIGUE & GENERAL TONIC    
2.   ANTI ASTHMATIC    
3.   COLCHICINE TABLETS    
4.   TABLETS FOR INFLUENZA AND COMMON COLD    
5.   ANTI ALLERGIC TABLETS     
6.   MULTI VITAMIN TABLETS, 500 MG EACH TABLET CONTAINS    
7.   ENTERO VIOFORM TABLETS    
8.   TABLETS FOR COMMON COLD    
9.   TABLETS FOR MENOAPUSE SYNDROMS    
10.  STIMULATING TABLETS    
11.  ANACIN TABLETS    
12.  IRON TABLETS    
13.  CAPSULES    
14.  ANTI INFLAMMATORY ANTIPYRETIC AND ANALYGERIC    
15.  BROAD SPECTRUM ANIT-BIOTIC CASPULES    
16.  IRON WITH VITAMIN CAPSULES    
17.  ANTI ANNEMIA CAPSULES    
18.  CHLORAMPHENICOL CAPSULES    
19.  HEAMATINIC CAPSULES    
20.  UROBIOTIC CAPSULES
INJECTIONS FORMULATIONS    
TERRAMYCIN 1 M    
AMPICILLIN INJECTION    
SULPHACETAMIDE EYE-DROP     
SULPHACETAMIDE EYE-DROP EACH ML CONTAINS    
BETENSOL-N-EYE/EAR DROPS CONTAINS    
SALIENT FEATURES OF FORMULATIONS OF DPHTHALMIC PREPARATIONS    
OXYTOCIN INJECTION    
OXYTOCIN -B VETC    
MANUFACTURING PROCESS OF INJECTIONS    
FILLING OF AMPOULES    
FORMULATIONS OF SYRUPS    
SYRUPS    
ANTI ALLERGIC COUGH SYRUP    
EDIATRIC SYRUP OF PARACETAMOL    
VICKS FORMULA 44 COUGH MIXTURE    
PARACETAMOL - VITAMINIC SYRUP    
MULTIVITIMAN SYRUP    
COUGH SYRUP    
1.   GENERAL TONIC (MULTI VITAMIN)    
2.   SODIUM GLYCEROPHOSPHATE 40 MG    
3.   VITAMIN B COMPLEX WITH DIGESTIVE ENZYMES    
TONIC LIQUID    
PALATABLE POTASSIUM SUPPLEMENT    
LOTION    
1.   EYE LOTION    
2.   SKIN LOTION (FOR SPOT & PIMPLES)    
3.   ANTI ALLERGIC LOTION (CALAMINE LOTION)    
TERRAMYCIN DENTAL PASTE    
BEPARINE CREAM    
ANTISEPTIC CREAM    
ANTI FUNGAL SKIN OINTMENT    
BURNOL OINTMENT    
FORMULATION OF OINTMENT BASES    
WASHABLE OINTMENT BASE (USED AS SCALP OINTMENT BASE)    
GREASE LESS BASE  (USED IN MAKING SKIN OINTMENT)    
MANUFACTURING PROCESS OF TABLETS    
FLOW DIAGRAM OF TABLET MAKING PLANT    
MANUFACTURING PROCESS OF LIQUIDS (SYRUP)    
FILTERATION    
BOTTLING    
FLOW DIAGRAM OF MIXING PLANT    
CAPSULE FILLING AND SEALING    
FILLING    
SEALING AND LOCKING    
FLOW DIAGRAM OF CAPSULE MAKING PLANT    
MANUFACTURE OF LOTION    
FLOW DIAGRAM OF LOTION MAKING PLANT    
OINTMENT AND PASTE MAKING    
FORMULATION    
MELTING    
MIXING    
FILLING    
MACHINERY REQUIRED    
FLOW DIAGRAM FOR PASTE & OINTMENT MAKING    
DEXTRAN 110 INJECTIONS    
SODIUM CHLORIDE AND DEXTROSE INJECTION    
BASIC RAW MATERIALS    
COMPOSITION OF I.V. FLUID    
COMPOSITION OF COMMON I.V. FLUID (MEQ/L)    
COMPOSITION OF I.V. FLUIDS    
COMPOSITION OF COMMERCIAL I.V. FLUID AVAILABLE    
MANUFACTURING PROCESS OF I.V. FLUID (FFS TECHNOLOGY)    
PROCESS FLOW DIAGRAM    
FORM FILL SEAL TECHNOLOGY    
1. FORM-FILL-SEAL TECHNOLOGY    
1.5 FILTRATION (MEMBRANE)    
PROCESS IN DETAILS OF I.V. FLUID    
1.   DISTILLED WATER PREPARATION    
2.   SOLUTION PREPARATION    
3. INJECTION BLOW MOULDING    
4. MOULDING PROCESS    
5. FILLING PROCESS    
6. SEALING PROCESS    
7. MOULD OPENING PROCESS    
FILTRATION AND FILLING    
STERILIZATION    
FLOW DIAGRAM OF MANUFACTURING OF I.V. FLUIDS    
ONCLOGY DRUGS    
FORMULATION OF LETROZOLE TABLETS    
FORMULATION OF ENZOLUTAMIDE CAPSULE    
FORMULATION OF TEMOZOLOMIDE CAPSULE    
PLANT LAYOUT    
SUPPLIERS OF PLANT AND MACHINERY FOR I.V. FLUID    
SUPPLIERS OF PHARMACEUTICAL PLANTS MACHINERY    
SUPPLIERS OF RAW MATERIALS    
GELATINE    
FOOD COLOURS    
SODIUM SULPHATE    
PINE OIL    
GLYCERINE    
CAUSTIC SODA    
METHYLATED SPIRIT    
ASPIRIN    
PARACETAMOL TABLETS (PCM)    
PAPAIN POWDER    
VITAMIN    
THYMOL    

        
APPENDIX – A:

 1.      COST OF PLANT ECONOMICS      
 2.      LAND & BUILDING                                      
 3.      PLANT AND MACHINERY                                  
 4.      FIXED CAPITAL INVESTMENT                             
 5.      RAW MATERIAL                                         
 6.      SALARY AND WAGES                                     
 7.      UTILITIES AND OVERHEADS                              
 8.      TOTAL WORKING CAPITAL                                
 9.      COST OF PRODUCTION                                   
10.      PROFITABILITY ANALYSIS                               
11.      BREAK EVEN POINT                                     
12.      RESOURCES OF FINANCE                           
13.      INTEREST CHART                                       
14.      DEPRECIATION CHART                                   
15.      CASH FLOW STATEMENT                                   
16.      PROJECTED BALANCE SHEET