The word “Pellet” has been used to describe a variety of systematically produced, geometrically defined agglomerates obtained from diverse starting materials utilizing different processing conditions. Pellets range in size, typically, between 0.5 – 1.5 mm, though other sizes could be prepared. Pellets are for pharmaceutical purposes and are produced primarily for the purpose of oral controlled-release dosage forms having gastro resistant or sustained-release properties or the capability of site-specific drug delivery. For such purposes, coated pellets are administered in the form of hard gelatin capsules or disintegrating tablets that quickly liberate their contents of pellets in the stomach. As drug-delivery systems become more sophisticated, the role of pellets in the design and development of dosage forms is increasing. Formulation of drugs in multiple-unit dosage forms, such as coated pellets filled in capsules or compressed into tablets, offers flexibility as to target-release properties. The safety and efficacy of the formulation is higher than that of other dosage forms. Solid dosage formulation and design usually involves a serious of compromises, since producing the desired properties frequently involves competing objectives. The correct selection and balance of excipients materials and processes in a solid dosage formulation, to achieve the desired response is not in practice easy to achieve. Pellets are of a great interest to the pharmaceutical industry for a variety of reasons. Palletized products not only offer flexibility in dosage form design and development, but are also utilized to improve the safety and efficiency of bioactive agents. Pellets range in size, between 0.5 to 1.5.

 

USES & APPLICATION

Pellets/ granules may have varied applications in varied industries. It just requires an innovative bend to use it to derive maximum profitability. The smooth surface & the uniform size of the pellets allow uniform coating not only for each pellet but also from batch to batch. Highlighted below are some of the few instances where smooth surfaced uniform pellets are being successfully used: Improved appearance of the products. Coating of pellets can be done with different drugs to enable a controlled release rate. In case of immediate Release Products larger surface area of pellets enables better distribution. Chemically incompatible products can be formed into pellets & delivered in a single dose by encapsulating them. In the chemical industries it is used to avoid powder dusting. Varied applications are possible in the pellet form. Eg: sustained release. Pellets ensure improved flow properties, and flexibility in formulation development and manufacture. The coating material may be colored with a dye material so that the beads of different coating thickness will be darker in color and distinguishable from those having fewer coats. The beads or granules of different thickness of coatings are blended in the desired proportions to give the desired effect. The thickness of the coat on the pellets dictates the rate at which the drug/ contents are released from the coated particles. A smooth surface of the pellets & uniform coating thickness for each pellet. By selecting the proper formulation, processing conditions and processing equipment it is possible to attain smooth surfaced & uniform pellets. The most common advantages of pelletization are: Improved appearance of the product and the core is pharmaceutically elegant. Pelletization offers flexibility in dosage form design and development, Pellets are less susceptible to dose dumping, It reduces localized concentration of irritative drugs, It improves safety and efficacy of a drug, Pellets offer reduced variation in gastric emptying rate and transit time, Pellets disperse freely in G.I.T. and invariably maximize drug absorption and also reduce peak plasma fluctuation, Pellets ensure improved flow properties in formulation development.

 

MARKET SURVEY

The Indian pharmaceutical industry is the fourth largest in the world in terms of volume of output and thirteenth in domestic demand. However, the Indian industry, valued at USD 17 bn in represented just over 1% of the global pharmaceutical industry (USD 1700 bn) in value terms. The domestic market is estimated at Rs 680 bn. According to the Federation of Indian Chambers of Commerce and Industry (FICCI), another apex industry association, there are some 6,000 firms engaged in the sector. In terms of revenue gene-ration, there are 100 big companies (including subsidiaries of MNCs) each with sales of at least USD 650,000, 200 medium size companies with sales ranging between USD 210,400 and USD 650,000; and 5700 small companies with sales of less than USD 210,400. Because many of these companies focus on producing similar generic or same drugs, the industry is characterized by fierce competition and high volumes, razor-thin profit margins, overcapacity, and declining prices. The growth has been driven by many factors, such as legislative reforms, growth in contract manufacturing and outsourcing, value added foreign acquisitions and joint ventures and India's acumen and expertise in reverse engineering of patented drug molecules. India has, in the meantime, been trying to comply with the World Trade Organization's Trade Related Intellectual Property Agreement (TRIPs) obligations. India is now among the top five pharmaceutical emerging markets. The Indian pharma industry has been growing at a compounded annual growth rate (CAGR) of more than 15 per cent over the last five years and has significant growth opportunities. The Indian pharmaceutical sector is expected to grow five-fold to reach Rs 5 lakh crore (US$ 91.45 billion) by 2020, as per Dr A J V Prasad, Joint Secretary, Department of Pharmaceuticals (DoP). The industry, particularly, has been the front runner in a wide range of specialties involving complex drugs' manufacture, development, and technology. With the advantage of being a highly organized sector, the number of pharmaceutical companies are increasing their operations in India.

 

Pharmaceutical Pellets and Granules, Detailed Project Report, Profile, Business plan, Industry Trends, Market research, survey, Manufacturing Process, Machinery, Raw Materials, Feasibility study, Investment opportunities, Cost and Revenue, market, Project, consultancy, services, entrepreneur, India, Technologies,  feasibility study, Identification, Project Feasibility, Profitable, Industrial, Pre-Investment, Pre-Feasibility Studies, Techno-Economic

 

PRESENT MANUFACTURERS

Abbott India Ltd.

Anglo-French Drugs &Inds. Ltd.

Biological E. Ltd.

Boehringer Mannheim India Ltd.

Cadila Laboratories Pvt. Ltd.

Cadila Pharmaceuticals Ltd.

Chemcel Biotech Ltd.

CosmeFarma Laboratories Ltd.

Fermenta Biotech Ltd.

H P M Industries Ltd.

Indian Drugs & Pharmaceuticals Ltd.

Inventia Healthcare Pvt. Ltd.

M S T C Ltd.

Mayo (India) Ltd.

Neo Corp Intl. Ltd.

Northern Minerals Ltd.

Pharmacia Healthcare Ltd.

Rhyme Organics & Chemicals Ltd.

Sandoz (India) Ltd.

Sanofi India Ltd.

Sarvodaya Labs Ltd.

Shiv Herbal Research Laboratory Ltd.

Sidmak Laboratories (India) Pvt. Ltd.

Smith Stanistreet Pharmaceuticals Ltd.

Stanpacks (India) Ltd.

T T K Healthcare Ltd

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Table of Contents

1.       District Profile & Geotechnical Site Characterization

1.1.    General

1.2.    Physical Characteristics

1.3.    Map

1.4.    Transportation and Communications

1.5.    Economy

2.       Introduction

3.       Application of Pellets

4.       Applications of Enteric Coating

5.       Product Details

5.1.    Itraconazole Pallets

5.2.    Medical Uses

5.3.    Producer Detail

5.4.    Pantoprazole Pellets

5.5.    Drug Usage

5.6.    Physiochemical Properties-

5.7.    Enteric Coating Formulations

5.8.    Sugar Pellets

5.9.    Sugar Pellets Application:

6.       Market Survey

6.1.    Drugs and Pharmaceuticals

6.1.1.Bulk Drugs and Drugs Formulations

6.1.2.Analgesics, Antipyretics and Tranquilizers

6.1.3.Paracetamol

6.1.4.Cardiovascular and Anti-T.B. Drugs

6.1.5.Anti-asthmatic and Anti-malarial Drugs

6.1.6.Antidiabetic-Insulin and Anaesthetics

6.1.7.Antibiotics and Anti-Dysentery Drugs

6.1.8.Vitamin-A and Other Vitamins

6.2.    Indian Pharmaceutical Industry

6.3.    Major Pharmaceutical Companies

6.4.    Pharmaceutical Sector in India

7.       Financial Analysis & Comparision of Major Indian Companies

7.1.    About Financial Statements of CMIE Database

7.2.    Profits & Appropriations

7.3.    Total Liabilities

7.4.    Total Assets

7.5.    Net Cash Flow from Operating Activities

7.6.    Section – I

7.6.1.Name of Company with Contact Details

7.6.2.Name of director(s)

7.6.3.Plant Capacity

7.6.4.Location of Plant

7.6.5.Name of Raw Material(S) Consumed with Quantity & Cost

7.7.    Section – II

7.7.1.Income & Expenses

7.7.2.Profits

7.7.3.Forex Transaction

7.7.4.Liabilities

7.7.5.Assets

7.7.6.Growth in Assets & Liabilities

7.7.7.Growth in Income & Expenditure

7.7.8.Liquidity Ratios

7.7.9.Profitability Ratio

7.7.10.    Return Ratios

7.7.11.    Cost as % ge of sales

7.7.12.    Working Capital & Turnover Ratios

7.7.13.    Structure of Assets & Liabilities (%)

7.7.14.    Cash Flow

8.       Export &Import Statistics Data of India

8.1.    Export Statistics Data for Pantoprazole Pellet

8.2.    Export Statistics Data for Itraconazole

8.3.    Import Statistics Data for Itraconazole

8.4.    Export Statistics Data for Sugar Pellet

8.5.    Import Statistics Data for Sugar

9.       Present Manufacturers

10.   Process of Pellets

10.1.Formulation

11.   Process Flow Diagram of Pellets

12.   Process of Granulation

13.   Process Flow Diagram of Granulation

14.   Suppliers of Plant & Machinery

15.   Suppliers of Raw Material

16.   Machinery Photographs

17.   Plant Layout

18.   Quotation of Plant, Machinery and Equipments from Supplier

 

PROJECT FINANCIALS

·         Project at a Glance

Annexure

·         Assumptions for Profitability workings ….…………………………………………....................... 1

·         Plant Economics…………………………………………………………………………….................... 2

·         Production Schedule……………………………………………………………………….................... 3

·         Land & Building…………………………………………………………………………….................... 4

§  Factory Land & Building

§  Site Development Expenses

·         Plant & Machinery………………………………………………………………………….................... 5

§  Indigenous Machineries

§  Other Machineries (Miscellaneous, Laboratory etc.)

·         Other Fixed Assets………………………………………………………………………….................... 6

§  Furniture & Fixtures

§  Pre-operative and Preliminary Expenses

§  Technical Knowhow

§  Provision of Contingencies

·         Working Capital Requirement Per Month………………………………………………................. 7

§  Raw Material

§  Packing Material

§  Lab & ETP Chemical Cost

§  Consumable Store

·         Overheads Required Per Month and Per Annum ……………………………………................. .8

§  Utilities & Overheads (Power, Water and Fuel Expenses etc.)

§  Royalty and Other Charges

§  Selling and Distribution Expenses

·         Salary and Wages ……………………………………………………………………………................. 9

·         Turnover Per Annum ………………………………………………………………………................ 10

·         Share Capital…………………………………………………………………………………................ 11

§  Equity Capital

§  Preference Share Capital

 

•        Annexure 1            ::        Cost of Project and Means of Finance

•        Annexure 2            ::        Profitability and Net Cash Accruals

§  Revenue/Income/Realisation

§  Expenses/Cost of Products/Services/Items

§  Gross Profit

§  Financial Charges    

§  Total Cost of Sales

§  Net Profit After Taxes

§  Net Cash Accruals

 

•        Annexure 3            ::        Assessment of Working Capital requirements

§  Current Assets

§  Gross Working Capital

§  Current Liabilities

§  Net Working Capital

§  Working Note for Calculation of Work-in-process

 

•        Annexure 4            ::        Sources and Disposition of Funds

•        Annexure 5            ::        Projected Balance Sheets

§  ROI (Average of Fixed Assets)

§  RONW (Average of Share Capital)

§  ROI (Average of Total Assets)

 

•        Annexure 6            ::        Profitability ratios

§  D.S.C.R

§  Earnings Per Share (EPS)

§  Debt Equity Ratio

 

•        Annexure 7            ::        Break-Even Analysis

§  Variable Cost & Expenses

§  Semi-Variable/Semi-Fixed Expenses

§  Profit Volume Ratio (PVR)

§  Fixed Expenses / Cost 

§  B.E.P

 

•        Annexure 8 to 11   ::        Sensitivity Analysis-Price/Volume

§  Resultant N.P.B.T

§  Resultant D.S.C.R

§  Resultant PV Ratio

§  Resultant DER

§  Resultant ROI

§  Resultant BEP

 

•        Annexure 12          ::        Shareholding Pattern and Stake Status

§  Equity Capital

§  Preference Share Capital

 

•        Annexure 13          ::        Quantitative Details-Output/Sales/Stocks

§  Determined Capacity P.A of Products/Services

§  Achievable Efficiency/Yield % of Products/Services/Items 

§  Net Usable Load/Capacity of Products/Services/Items   

§  Expected Sales/ Revenue/ Income of Products/ Services/ Items   

 

•        Annexure 14          ::        Product wise domestic Sales Realisation

•        Annexure 15          ::        Total Raw Material Cost

•        Annexure 16          ::        Raw Material Cost per unit

•        Annexure 17          ::        Total Lab & ETP Chemical Cost

•        Annexure 18          ::        Consumables, Store etc.

•        Annexure 19          ::        Packing Material Cost

•        Annexure 20          ::        Packing Material Cost Per Unit

•        Annexure 21          ::        Employees Expenses

•        Annexure 22          ::        Fuel Expenses

•        Annexure 23          ::        Power/Electricity Expenses

•        Annexure 24          ::        Royalty & Other Charges

•        Annexure 25          ::        Repairs & Maintenance Expenses

•        Annexure 26          ::        Other Manufacturing Expenses

•        Annexure 27          ::        Administration Expenses

•        Annexure 28          ::        Selling Expenses

•        Annexure 29          ::        Depreciation Charges – as per Books (Total)

•        Annexure 30          ::        Depreciation Charges – as per Books (P & M)

•        Annexure 31          ::        Depreciation Charges - as per IT Act WDV (Total)

•        Annexure 32          ::        Depreciation Charges - as per IT Act WDV (P & M)

•        Annexure 33          ::        Interest and Repayment - Term Loans

•        Annexure 34          ::        Tax on Profits

•        Annexure 35          ::        Projected Pay-Back Period And IRR