Amoxicillin (Pharma Grade) (Capacity: 3.2 MT/Day)

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)