PROJECT REPORT

Of

MEDICINAL TABLETS

PURPOSE OF THE DOCUMENT

This particular pre-feasibility is regarding Medicinal tablets Manufacturing unit.

The objective of the pre-feasibility report is primarily to facilitate potential entrepreneurs in project
identification for investment and in order to serve his objective; the document covers various aspects
of the project concept development, start-up, marketing, finance and management.

[We can modify the project capacity and project cost as per your requirement. We can also prepare
project report on any subject as per your requirement.]

Lucknow Office: Sidhivinayak Building ,

27/1/B, Gokhlley Marg, Lucknow-226001

Delhi Office : Multi Disciplinary Training

Centre, Gandhi Darshan Rajghat,
New Delhi 110002

Email : [email protected]
Contact : +91 7526000333, 444, 555
 PROJECT AT GLANCE

1 Name of Proprietor/Director XXXXXXXX

2 Firm Name XXXXXXXX
3 Registered Address XXXXXXXX
4 Nature of Activity XXXXXXXX
5 Category of Applicant XXXXXXXX
6 Location of Unit XXXXXXXX
7 Cost of Project 22.47 Rs. In Lakhs
8 Means of Finance
i) Own Contribution 2.25 Rs. In Lakhs
ii) Term Loan 15.12 Rs. In Lakhs
iii) Working Capital 5.10 Rs. In Lakhs
9 Debt Service Coverage Ratio 3.00
10 Break Even Point 41%
11 Power Requiremnet 30 KW
12 Employment 14 Persons
Pharmaceuticals excipients,
13 Major Raw Materials pvc,aluminium foils and
cartons.
14 Details of Cost of Project & Means of Finance
Cost of Project Amount in Lacs
Particulars Amount
Land and building Owned/Leased
Plant & Machinery 15.05
Furniture & Fixture 0.75
Other Misc Assets 1.00
Working Capital Requirement 5.67
Total 22.47
Means of Finance
Particulars Amount
Own Contribution 2.25
Term Loan 15.12
Working capital Loan 5.10
Total 22.47
 MEDICINAL TABLETS
MANUFACTURING UNIT

1. INTRODUCTION

Oral drug delivery is the most convenient, high patient compliance, cost-effective, and safe
route of administration to treat various diseases. They come as solid tablets,
capsules, chewable tablets, lozenges to be swallowed whole or sucked on, or as drinkable
liquids such as drops, syrups, or solutions. In most cases, the ingredients in oral medication
don't enter the bloodstream until they reach the stomach or bowel. A tablet is
a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid unit dosage form.
Tablets may be defined as the solid unit dosage form of medicament or medicaments with
suitable excipients. It comprises a mixture of active substances and excipients, usually
in powder form, pressed or compacted from a powder into a solid dose. Tablets are prepared
either by moulding or by compression. The excipients can include diluents, binders or
granulating agents, glidants (flow aids) and lubricants to ensure efficient
tableting; disintegrants to promote tablet break-up in the digestive tract; sweeteners or flavours
to enhance taste, and pigments to make the tablets visually attractive or aid in visual identification of an unknown
tablet. A polymer coating is often applied to make the tablet smoother and easier to swallow, to control the release
rate of the active ingredient, to make it more resistant to the environment (extending its shelf life), or to enhance the
tablet's appearance. Medicinal tablets were originally made in the shape of a disk of whatever colour their
components determined, but are now made in many shapes and colours to help distinguish different medicines.
Tablets are often stamped with symbols, letters, and numbers, which enable them to be identified. Sizes of tablets to
be swallowed range from a few millimeters to about a centimeter. The compressed tablet is the most popular dosage
form in use today. About two-thirds of all prescriptions are dispensed as solid dosage forms, and half of these are
compressed tablets. A tablet can be formulated to deliver an accurate dosage to a specific site; it is usually taken
orally, but can be administered sublingually, buccally, rectally,or intravaginally. The tablet is just one of the
many forms that an oral drug can take suchas syrups, elixirs, suspensions, and emulsions.

2 PRODUCT DISCRIPTION

2.1 PRODUCT USES

Tablets are chemicals or compounds used to cure, halt, or prevent disease; easesymptoms; or help in the
diagnosis of illnesses.
2.2 MANUFACTURING PROCESS

The manufacturing process is as follows-

Raw material procurement

Making Process
Testing

Raw Material Procurement

The raw materials are checked strictly as per established quality standards and requirements. Individual
supplier assessment and supplier rating are done depending upon the rejection levels at the incoming quality
control stage. Sorting of raw material will be done as per material type or specifications. The material will be
stored in; a dust-free, moisture-free, neat, and clean environment. Quality control of tablet raw materials(APIs
and excipients) is one of the main tasks of the quality control unit in any drug manufacturing industry. Raw
materials must undergo the necessary tests.

It is often sufficient if identification testing is conducted on the individual packages/containers and content and
purity determination in mixed samples. Every manufacturer has the opportunity to carry out further testing if
they deem it necessary for guaranteeing a smooth-running production process or a very high-quality product.
Starting materials are released only after their quality is established or judged as satisfactory. Raw materials
that fail the quality control test are rejected and returned to the supplier. Any risks that may emanate from
starting materials of inappropriate quality must be avoided to prevent product failure and to ensure a consistent
level of quality, as well as safety in consumer and industrial products.

Tablets Making Process

1. Dispensing: After receiving raw material it will be procured in the RM store. At dispensing, booth raw
material sampling is done. Each ingredient in the tablet formula is weighed and accurately dispensed as
per dose. This is one of the critical steps in any type of formulation process and should be done under
technical supervision. After sampling it will be sent to under testing. After testing raw material is stored in
an approved area. After dispensing the material is then kept in a pass bag for further processing. After
dispensing material is collected through a pass box. Here material will be cross-checked. According to
MFR, it is then processed step by step. Shifting, Mixing, Granulation, Drying, Lubrication, etc is then performed
step by step. Formulation ingredients must be in finely divided form, otherwise, size reduction should be carried out
for better flow property and easy mixing.
2. Powder blending: Powders are mixed using a suitable blender to obtain a uniform and homogeneous
powder mix. The drug substance and excipients are mixed in geometric dilution.
3. Granulation: Here small powder particles are gathered together into layers, and permanent aggregates to
render them into free-flowing states.
4. Drying and dry screening: Screened wet granules need to be dried for a particular period in a tray dry or
fluid bed dryer at a controlled temperature not exceeding 550C. Dried granules are screened through the
appropriate mesh screen. Here lubrication is done. Lubricated tablet powder is stored separately and sent
for sampling.
5. Tablet compression: Quality passed lubricated granules are used for compression. Before tablet
compression line check will be done. The machine is properly cleaned or not is checked. For compression
lubricated granules are fed into the hopper, according to MFR parameters tablets are compressed. This
step involves the compression of granules into flat or convex, round, oblong, or unique shaped, scored,

or unscored tablets; engraved with an identifying symbol and/ or code number using atablet press. Along
with this process, yield is recorded on BMR.
6. Coating: Tablets and granules are coated if there is a need to mask the unpleasant taste/odor of some drug
substance or to increase the aesthetic appeal of uncoated tablets as well as to modify the release or control
the release of drug substances from tablets. This is achieved by enclosing or covering the core tablet or
granules with coating solutions. Color solution is made first before coating tablets. After coating, the
sample is sent to QC for testing.
7. Packing: First primary packing is done. Blister or Alu alu machine is used for tablet striping and packing.
Hydrogen flushing is done while tablet striping. PVC and aluminum foil is used for tablet packing. After
 QC, the tablet is then sent for secondary packing; carton packing. After mass packing, again final QC is
done and the tablet is ready to dispatch.

Testing
 Quality Control

3 PROJECT COMPONENTS

3.1 Land /Civil Work

The land required for this manufacturing unit will be approx. around 2,500-3,000 square feet. Land Purchase
and Building Civil Work Cost have not been considered as part of the cost of project. It is expected that the
premises will be on rental and approximate rentals assumed of the same will be Rs. 40,000 per month.

Workshop Area- This area includes the setup and foundation space for all equipment’s, work floor area, etc.
Total workshop area is approx. 1,500 Sqft.
Inventory Area- This area includes the storage space for all the raw materials and finished goods. Total
inventory area is approx. 700 Sqft.
Office Area – This space includes staff working region, their accommodation space. Total workshop area is
 approx. 200 Sqft. This may be considered above the ground floor.
Parking Space, Electric Mounting Space, and Others. This could be approx. 100 Sqft.

Land and building requirement may vary depending on the size of project

3.2 Plant & Machinery

Size reduction equipment: Size reduction equipment such as hammer mill, vibrationmill, roller mill, pin
mill, fluidized energy mill, end-runner mill, edge runner mill, cutter mill, and the ball mill is used for
size reduction of raw material if required.

Mixing equipment
Mixing equipment such as pneumatic mixers (air-mix mixer or air-driven mixer), diffusion/ tumbling
mixers (e.g., V-blender, double cone blender, cubic mixer, drum blender), convective mixers (e.g., ribbon
blenders, orbiting screw mixers, horizontal high-intensity blenders, planetary blenders, diffusion mixer
with intensifier bar/agitator, Forberg blenders, horizontal double arm mixers, vertical high-intensity mixer)
is used for mixing raw materials.
Granulators
Various granulators such as rotating shape granulators, mechanical agitator granulators (e.g., ribbon or
paddle blender, sigma blade mixer, planetary mixer, orbiting screw mixers), high-shear granulator,
fluidized bed granulator, dry granulator, etc. are used for the granulation process.

Dying equipment
Dryers such as spray dryers, rotary dryers, fluidized bed dryers, etc. are used for drying granules or raw
material.
Tableting machine
Single punch tablet press and multi-station/ rotary tablet press (e.g., High-speed rotary tablet machines and
multi-layer rotary tablet machines) are used for tablet compression.

Coating and polishing machines for coated tablets

Standard coating pan, perforated pan, fluidized bed/ Air suspension coating system, etc. This machine is
used for the tablet coating process.
Packaging machines
Blister packaging machines, strip packing machines, Alu-Alu/aluminum foil packaging machines, etc. are
used for tablet packing.

Other:
Coating equipment, weighing balance, quality control equipment, etc. Weighing balance/ balances: bulk
weighing balance (weighs in kilogram), electronic weighing balance (weighs in grams and milligrams).
Quality control equipment: disintegration equipment, USP Dissolution Tester, Tablet Hardness Tester,
Tablet Thickness Tester,Tablet Friability Testers, etc.
 S No. Name of the machineries Unit Price Qty Cost (INR)
1. Vibro Shifter 75,000 1 75,000
2. Rapid Mixture Granualtor 3,38,000 1 3,38,000
3. Tablet Compression Machine 3,50,000 1 3,50,000
4. CGMP Model Fluid Bed Dryer 2,50,000 1 2,50,000
5. Cone Blender 1,35,000 1 1,35,000
6. Coating Pan 1,27,000 1 1,27,000
7. Packaging Machine 2,29,500 1 2,29,500
TOTAL 15,04,500

Note: The aforesaid cost of Plant and Machinery is inclusive of GST and other
transportation cost.

4 LICENSE AND APPROVALS

MSME Udyam online registration.

GST Registration
BIS Certification
Drug licenses (FDA)
BIS certification
NOC from the Fire and Pollution control board
PROJECTED BALANCE SHEET (in Lacs)

PARTICULARS 1st year 2nd year 3rd year 4th year 5th year
Liabilities
Capital
Opening Balance 4.73 6.31 8.32 10.73
Add:- Own Capital 2.25
Add:- Retained Profit 5.48 7.58 9.01 10.41 11.85
Less:- Drawings 3.00 6.00 7.00 8.00 9.00

Closing Balance 4.73 6.31 8.32 10.73 13.58

Term Loan 13.44 10.08 6.72 3.36 -
Working Capital Limit 5.10 5.10 5.10 5.10 5.10
Sundry Creditors 4.77 3.76 4.51 4.35 5.55
Provisions & Other Liabilities 1.00 1.50 1.80 2.16 2.59
TOTAL : 29.03 26.75 26.45 25.69 26.81
Assets
Fixed Assets ( Gross) 16.80 16.80 16.80 16.80 16.80
Gross Depriciation 2.48 4.59 6.39 7.93 9.23
Net Fixed Assets 14.31 12.20 10.40 8.87 7.56

Current Assets
Sundry Debtors 4.08 4.91 5.60 6.35 7.16
Stock in Hand 6.36 7.64 8.71 9.86 11.11
Cash and Bank 0.28 0.25 0.24 0.21 0.48
Loans and advances/other current assets 4.00 1.75 1.50 0.40 0.50
TOTAL : 29.03 26.75 26.45 25.69 26.81
PROJECTED CASH FLOW STATEMENT (in Lacs)

PARTICULARS 1st year 2nd year 3rd year 4th year 5th year
SOURCES OF FUND
Own Margin 2.25
Net Profit 5.76 8.16 10.19 12.19 14.25
Depriciation & Exp. W/off 2.48 2.11 1.80 1.53 1.31
Increase in Cash Credit 5.10 - - - -
Increase In Term Loan 15.12 - - - -
Increase in Creditors 4.77 - 1.01 0.75 - 0.16 1.20
Increase in Provisions & Other liabilities 1.00 0.50 0.30 0.36 0.43

TOTAL : 36.47 9.76 13.04 13.91 17.19

APPLICATION OF FUND
Increase in Fixed Assets 16.80
Increase in Stock 6.36 1.28 1.07 1.16 1.25
Increase in Debtors 4.08 0.83 0.69 0.75 0.81
Increase in loans and advances 4.00 - 2.25 - 0.25 - 1.10 0.10
Repayment of Term Loan 1.68 3.36 3.36 3.36 3.36
Drawings 3.00 6.00 7.00 8.00 9.00
Taxation 0.28 0.57 1.18 1.78 2.40
TOTAL : 36.19 9.79 13.05 13.95 16.92

Opening Cash & Bank Balance - 0.28 0.25 0.24 0.21

Add : Surplus 0.28 -0.03 -0.01 -0.03 0.27
Closing Cash & Bank Balance 0.28 0.25 0.24 0.21 0.48
PROJECTED PROFITABILITY STATEMENT (in Lacs)

PARTICULARS 1st year 2nd year 3rd year 4th year 5th year
Capacity Utilisation % 53% 58% 63% 68% 73%
SALES
MEDICINAL TABLETS 122.35 147.35 168.11 190.58 214.88

Total 122.35 147.35 168.11 190.58 214.88

COST OF SALES
Raw material cost 71.55 80.65 90.23 100.31 110.92
Electricity Expenses 3.82 4.18 4.54 4.90 5.26
Depreciation 2.48 2.11 1.80 1.53 1.31
Wages & labour 15.84 18.69 22.06 26.03 30.71
Repair & maintenance 1.22 1.84 2.52 3.34 3.76
Consumables 3.67 4.42 5.04 5.72 6.45
Packaging cost 2.45 3.32 4.20 5.24 6.45
Cost of Production 101.03 115.21 130.39 147.06 164.84
Add: Opening Stock - 6.12 7.37 8.41 9.53
Less: Closing Stock 6.12 7.37 8.41 9.53 10.74
Cost of Sales 94.91 113.96 129.35 145.94 163.63
GROSS PROFIT 27.44 33.39 38.76 44.65 51.25
Salary to Staff 11.16 13.17 15.54 18.34 21.64
Interest on Term Loan 1.49 1.31 0.94 0.57 0.20
Interest on working Capital 0.56 0.56 0.56 0.56 0.56
Rent 4.50 5.04 5.64 6.32 7.08
Selling & Administration Expenses 3.98 5.16 5.88 6.67 7.52
TOTAL 21.68 25.24 28.57 32.46 37.00
NET PROFIT 5.76 8.16 10.19 12.19 14.25
Taxation 0.28 0.57 1.18 1.78 2.40
PROFIT (After Tax) 5.48 7.58 9.01 10.41 11.85
CALCULATION OF D.S.C.R

PARTICULARS 1st year 2nd year 3rd year 4th year 5th year

CASH ACCRUALS 7.96 9.70 10.81 11.94 13.16

Interest on Term Loan 1.49 1.31 0.94 0.57 0.20
Total 9.45 11.01 11.75 12.51 13.36

REPAYMENT
Instalment of Term Loan 1.68 3.36 3.36 3.36 3.36
Interest on Term Loan 1.49 1.31 0.94 0.57 0.20

Total 3.17 4.67 4.30 3.93 3.56

DEBT SERVICE COVERAGE RATIO 2.98 2.36 2.73 3.18 3.75

AVERAGE D.S.C.R. 3.00
 REPAYMENT SCHEDULE OF TERM LOAN
Interest 11.00%
Closing
Year Particulars Amount Addition Total Interest Repayment Balance
1st Opening Balance -
1st month 15.12 15.12 - 15.12
2nd month 15.12 - 15.12 0.14 - 15.12
3rd month 15.12 - 15.12 0.14 - 15.12
4th month 15.12 - 15.12 0.14 - 15.12
5th month 15.12 - 15.12 0.14 - 15.12
6th month 15.12 - 15.12 0.14 - 15.12
7th month 15.12 - 15.12 0.14 0.28 14.84
8th month 14.84 - 14.84 0.14 0.28 14.56
9th month 14.56 - 14.56 0.13 0.28 14.28
10th month 14.28 - 14.28 0.13 0.28 14.00
11th month 14.00 - 14.00 0.13 0.28 13.72
12th month 13.72 - 13.72 0.13 0.28 13.44
1.49 1.68
2nd Opening Balance
1st month 13.44 - 13.44 0.12 0.28 13.16
2nd month 13.16 - 13.16 0.12 0.28 12.88
3rd month 12.88 - 12.88 0.12 0.28 12.60
4th month 12.60 - 12.60 0.12 0.28 12.32
5th month 12.32 - 12.32 0.11 0.28 12.04
6th month 12.04 - 12.04 0.11 0.28 11.76
7th month 11.76 - 11.76 0.11 0.28 11.48
8th month 11.48 - 11.48 0.11 0.28 11.20
9th month 11.20 - 11.20 0.10 0.28 10.92
10th month 10.92 - 10.92 0.10 0.28 10.64
11th month 10.64 - 10.64 0.10 0.28 10.36
12th month 10.36 - 10.36 0.09 0.28 10.08
1.31 3.36
3rd Opening Balance
1st month 10.08 - 10.08 0.09 0.28 9.80
2nd month 9.80 - 9.80 0.09 0.28 9.52
3rd month 9.52 - 9.52 0.09 0.28 9.24
4th month 9.24 - 9.24 0.08 0.28 8.96
5th month 8.96 - 8.96 0.08 0.28 8.68
6th month 8.68 - 8.68 0.08 0.28 8.40
7th month 8.40 - 8.40 0.08 0.28 8.12
8th month 8.12 - 8.12 0.07 0.28 7.84
9th month 7.84 - 7.84 0.07 0.28 7.56
10th month 7.56 - 7.56 0.07 0.28 7.28
11th month 7.28 - 7.28 0.07 0.28 7.00
 12th month 7.00 - 7.00 0.06 0.28 6.72
0.94 3.36
4th Opening Balance
1st month 6.72 - 6.72 0.06 0.28 6.44
2nd month 6.44 - 6.44 0.06 0.28 6.16
3rd month 6.16 - 6.16 0.06 0.28 5.88
4th month 5.88 - 5.88 0.05 0.28 5.60
5th month 5.60 - 5.60 0.05 0.28 5.32
6th month 5.32 - 5.32 0.05 0.28 5.04
7th month 5.04 - 5.04 0.05 0.28 4.76
8th month 4.76 - 4.76 0.04 0.28 4.48
9th month 4.48 - 4.48 0.04 0.28 4.20
10th month 4.20 - 4.20 0.04 0.28 3.92
11th month 3.92 - 3.92 0.04 0.28 3.64
12th month 3.64 - 3.64 0.03 0.28 3.36
0.57 3.36
5th Opening Balance
1st month 3.36 - 3.36 0.03 0.28 3.08
2nd month 3.08 - 3.08 0.03 0.28 2.80
3rd month 2.80 - 2.80 0.03 0.28 2.52
4th month 2.52 - 2.52 0.02 0.28 2.24
5th month 2.24 - 2.24 0.02 0.28 1.96
6th month 1.96 - 1.96 0.02 0.28 1.68
7th month 1.68 - 1.68 0.02 0.28 1.40
8th month 1.40 - 1.40 0.01 0.28 1.12
9th month 1.12 - 1.12 0.01 0.28 0.84
10th month 0.84 - 0.84 0.01 0.28 0.56
11th month 0.56 - 0.56 0.01 0.28 0.28
12th month 0.28 - 0.28 0.00 0.28 -
0.20 3.36
DOOR TO DOOR 60 MONTHS
MORATORIUM PERIOD 6 MONTHS
REPAYMENT PERIOD 54 MONTHS
 DISCLAIMER

The views expressed in this Project Report are advisory in nature. SAMADHAN
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considering specific requirement of the project, capacity and type of plant and
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