AMOXICILLIN (PHARMA GRADE)
[EIRI/EDPR/4598] J.C.: 2815INR, 2815US$
INTRODUCTION
Amoxicillin is one of the several semi synthetic derivatives of 6-aminopenicillanic acid (6-APA) developed at Beecham, England in the 1960s.
Amoxicillin is used to treat certain infections caused by gram-positive bacteria, such as pneumonia, bronchitis, and gonorrhea and infections of the ears, nose, throat, urinarytract, and skin, as well as some gram-negative bacteria. Amoxicillin belongs to a class of medications called penicillin-like (beta-lactam) antibiotics.
Amoxicillin is included in the penicillin group of compounds which are well documented as sensitizing agents, causing anaphylaxis type allergic responses in susceptible patients. Dedicated manufacturing equipment and manufacturing sites are therefore recommended for amoxicillin production. Qualitative formulae for amoxicillin dispersible tablet formulations, DisperMox® and Flemoxin Solutab®, are described with proposed functions of the excipients along with US Food and Drug Administration (FDA) inactive ingredient database (IID) limits for the individual excipient. Amoxicillin trihydrate dispersible tablets can be manufactured by using dry granulation process. Requirements for manufacturing equipment along with the proposed manufacturing process have been outlined. Possible scale-up recommendations are included in accordance with US FDA’s Scale Up and Post Approval Changes Guidance for Immediate Release formulations.
COST ESTIMATION
Plant Capacity 3.2052 MT/Day
Land & Building (10,000 sq.mt.) Rs. 18.07 Cr
Plant & Machinery Rs. 3.50 Cr
Working Capital for 1 Month Rs. 9.92 Cr
Total Capital Investment Rs. 32.24 Cr
Rate of Return 46%
Break Even Point 42%
CONTENTS
INTRODUCTION
CHEMICAL STRUCTURE AND FORMULA
CHEMICAL STRUCTURE/FORMULA
PROPERTIES AND CHARACTERISTICS
PHYSICAL PROPERTIES
CRYSTAL FORMS
MELTING POINT (°C)
OPTICAL ROTATION
SYNTHETIC ROUTES
FIGURE: SYNTHESIS OF AMOXICILLIN THROUGH ENZYMATIC AND CHEMICAL ROUTES
EXAMPLES OF PROCESSES FOR OBTAINING AMOXICILLIN:
BULK DRUG INDUSTRY
SIGNIFICANCE OF API’S IN PHARMACEUTICAL INDUSTRY
CURRENT STATUS OF API INDUSTRY
GLOBAL TRADE
TABLE: MAJOR DESTINATIONS FOR BULK DRUGS IN TERMS OF VALUE AND QUANTITY IN 2018
TABLE: MAJOR SOURCES OF APIS
INVESTMENT
TABLE: INVESTMENTS IN PHARMACEUTICALS
OVERVIEW OF PHARMACEUTICAL INDUSTRY
(TRADE IN PHARMACEUTICALS)
(REGION WISE INDIA’S PHARMA EXPORTS FY 2019-20)
EXPORTS
INVESTMENTS AND RECENT DEVELOPMENTS
GOVERNMENT INITIATIVES
AS PER THE UNION BUDGET 2023-24:
AYUSHMAN BHARAT DIGITAL MISSION (ABDM):
SCHEME FOR DEVELOPMENT OF PHARMA INDUSTRY – UMBRELLA
SCHEME:
AS PER THE UNION BUDGET 2022-23:
ROAD AHEAD
GLOBAL MARKET OVERVIEW OF PHARMACEUTICAL INDUSTRY
MOLECULE TYPE INSIGHTS
FORMULATION INSIGHTS
ROUTES OF ADMINISTRATION INSIGHTS
THERAPY AREA INSIGHTS
PRESCRIPTION INSIGHTS
AGE GROUP INSIGHTS
SALES CHANNEL INSIGHTS
REGIONAL INSIGHTS
MANUFACTURING PROCESS OF AMOXYCILLIN
PROCESS FLOW DIAGRAM
MASS BALANCE
PRINCIPLES OF PLANT LAYOUT
STORAGE LAYOUT:
EQUIPMENT LAYOUT:
SAFETY:
PLANT EXPANSION:
FLOOR SPACE:
UTILITIES SERVICING:
BUILDING:
MATERIAL-HANDLING EQUIPMENT:
RAILROADS AND ROADS:
MAJOR PROVISIONS IN ROAD PLANNING FOR MULTIPURPOSE SERVICE ARE:
PLANT LOCATION FACTORS
PRIMARY FACTORS
1. RAW-MATERIAL SUPPLY:
2. MARKETS:
3. POWER AND FUEL SUPPLY:
4. WATER SUPPLY:
5. CLIMATE:
SPECIFIC FACTORS
6. TRANSPORTATION:
A. AVAILABILITY OF VARIOUS SERVICES AND PROJECTED RATES
7. WASTE DISPOSAL:
8. LABOR:
9. REGULATORY LAWS:
10. TAXES:
11. SITE CHARACTERISTICS:
12. COMMUNITY FACTORS:
13. VULNERABILITY TO WARTIME ATTACK:
14. FLOOD AND FIRE CONTROL:
EXPLANATION OF TERMS USED IN THE PROJECT REPORT
1. DEPRECIATION:
2. FIXED ASSETS:
3. WORKING CAPITAL:
4. BREAK-EVEN POINT:
5. OTHER FIXED EXPENSES:
6. MARGIN MONEY:
7. TOTAL LOAD:
8. LAND AREA/MAN POWER RATIO:
PROJECT IMPLEMENTATION SCHEDULES
INTRODUCTION
PROJECT HANDLING
PROJECT SCHEDULING
PROJECT CONSTRUCTION SCHEDULE
TIME SCHEDULE
ADDRESSES OF RAW MATERIAL SUPPLIERS
ADDRESSES OF PLANT AND MACHINERY SUPPLIERS
APPENDIX – A:
01. PLANT ECONOMICS
02. LAND & BUILDING
03. PLANT AND MACHINERY
04. OTHER FIXED ASSESTS
05. FIXED CAPITAL
06. RAW MATERIAL
07. SALARY AND WAGES
08. UTILITIES AND OVERHEADS
09. TOTAL WORKING CAPITAL
10. TOTAL CAPITAL INVESTMENT
11. COST OF PRODUCTION
12. TURN OVER/ANNUM
13. BREAK EVEN POINT
14. RESOURCES FOR FINANCE
15. INSTALMENT PAYABLE IN 5 YEARS
16. DEPRECIATION CHART FOR 5 YEARS
17. PROFIT ANALYSIS FOR 5 YEARS
18. PROJECTED BALANCE SHEET FOR (5 YEARS)
