Detailed Project Report (DPR) on bulk drugs

BULK DRUGS
[CODE NO. 2088]  

A bulk drug — also called active pharmaceutical ingredient (API) — is the chemical molecule in a pharmaceutical product (medicines we buy from the chemist) that lends the product the claimed therapeutic effect.
In other words, it is the substance responsible for the product being a medicine, penicillin to give one example. As is evident from this, there are ingredients other than the API in products sold as medicines. These inactive ingredients-excipients — may or may not change from product to product, while the bulk drug would inevitably remain the same as it is the identity of the medicine.
When the bulk drug is absent, the product is no longer a medicine and when it is changed, it is a new medicine. One may ask if the existence of the inactive ingredients signify anything to the patient. In the case of most of the existing bulk drugs, change of inactive ingredients don't impact the curative quality of the product, although there are exceptions.
This means the drug manufacturers more or less have the liberty to "formulate" the bulk drug using excipents of his choice depending on chemical feasibility and commercial interests. The medicines in the markets in the "form" of tablets, capsules, syrups, drops, intravenous fluids etc., are therefore "formulations." In plain language, the products we refer to as medicines are formulations (of bulk drugs) and not bulk drugs per se.

Active Pharmaceutical Ingredients (API) or bulk drugs are the principal ingredients for finished pharmaceutical products. Intermediates are the compounds from which active pharmaceutical ingredients are prepared. APIs cannot be administered directly to the patient, and other inactive substances called excipients are added to stabilise the mixture. This end product, which includes the API and the excipient, is referred to as a formulation. Formulations are the pharmaceutical products administered to patients and can take the form of tablets, capsules, syrups, ointments, creams, injectables etc.

The global API market can broadly be divided into regulated and semi regulated markets. The semi regulated markets offer low entry barriers in terms of regulatory requirements and intellectual property rights. The highly regulated markets, like the United States and Europe, have high entry barriers in terms of intellectual property rights and regulatory requirements, including facility approvals. As a result, there is a premium for quality and regulatory compliance along with relatively greater stability for both volumes and prices.

The regulatory process by which API manufacturers generally register their products for commercial sale in the U.S. and other similarly regulated countries is via the filing of a Drug Master File (DMF). DMFs are confidential documents containing information on the manufacturing facility and processes used in the manufacture, characterization, quality control, packaging and storage of an API. The DMF is reviewed for completeness by the FDA, or other similar regulatory agencies in other countries, in conjunction with applications filed by finished dosage formulation manufacturers, requesting approval to use the given API in the production of their drug products. For European markets, companies need to submit a European Drug Master File (EDMF) and, where applicable, obtain a certificate of suitability (CoS) from the European Directorate for the Quality of Medicines.


 COST ESTIMATION

Plant Capacity                                              1500.00 Kgs./day
Land & Building (3000 Sq.Mr)                    Rs. 3.90    Cr
Plant & Machinery                                         Rs. 6.05   Cr
W.C. for 2 Months                                          Rs. 9.78    Cr
Total Capital Investment                              Rs.  20.00 Cr
Rate of Return                                                53%
Break Even Point                                            33%


INTRODUCTION    
OVERVIEW OF INDIAN PHARMACEUTICAL INDUSTRY    
TREND & OUTLOOK OF BULK DRUGS INDUSTRY    
MARKET SURVEY    
IMPORT DATA OF BULK DRUG    
GLOBAL MARKET POSITION OF BULK DRUGS    
PRESENT MANUFACTURER/SUPPLIERS OF BULK DRUGS    
MANUFACTURING PROCESS OF DRUGS    
MANUFACTURING PROCESS    
FLOW DIAGRAM OF BULK DRUG MANUFACTURING PROCESS    
PROCESS FLOW DIAGRAM FOR 2-ACETYL THIOPHENE    
PROCESS FLOW DIAGRAM FOR 2-ACETYL BENZO (B) THIOPHENE    
PROCESS FLOW DIAGRAM FOR CAMPHOR SULFONYL CHLORIDE    
MANUFACTURING PROCESS OF ETHYL 2-OXO-4-PHENYL BUTYRATE    
PROCESS FLOW DIAGRAM    
SWOT ANALYSIS OF INDIAN PHARMACEUTICAL INDUSTRY    
PRINCIPLES OF PLANT LAYOUT    
PLANT LOCATION FACTORS    
EXPLANATION OF TERMS USED IN THE PROJECT REPORT    
PROJECT IMPLEMENTATION SCHEDULES    
PLANT LAYOUT    
SUPPLIERS OF RAW MATERIALS    
COMPLETE PLANT SUPPLIERS    
SUPPLIERS OF PLANT AND MACHINERY    

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