BANKABLE BUSINESS PLAN 2013

BANKABLE BUSINESS PLAN ON TABLET SPLITTING

TECHNOLOGY

PREPARED BY: ABHISHEK A. CHAUHAN – 12F49

RAJAL R. BRAHMBHATT – 12M74

VRUSTI B. RAO – 12F84

SUBMITTED TO: DR. RAJU M. RATHOD – GHPIBM

DATE OF SUBMISSION: 20th AUGUST 2013

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I. INTRODUCTION

A. About the Project:

We have developed a suite of proprietary pharmaceutical tablet technologies that can be applied
to almost all formulations to create a dose – adjustable tablets. This technology can sharply
differentiate a product with clinically relevant enhancements by giving physicians and patients
unprecedented dose flexibility within a single tablet.

B. Product to be manufactured and its end user applications and consumers:

The product that will be manufactured will be the technology that can split the tablet in equal
pieces without any change in their efficacy levels. The key to the suite of our product is the
unique of drug free layer within each tablet that serves as a breaking region. When dividing these
tablets, the break occurs in drug free layer. This guarantees a precise smaller dose every time,
eliminating issues with crumbling and unpredictable doses.

This unique technology will be used by the pharmaceutical companies globally. Our
technologies are suitable for single and combination agent formulations, and for standard and
controlled release formulations. The technology is also useful for combining incompatible
formulations into a single dosage form.

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II. PERSONAL INFORMATION ABOUT PROMOTERS

1. Personal Details:

NAME ADDRESS TELE.NOS DATE OF AGE EDUCATION

BIRTH QUALIFICATION
Mr. Abhishek 110 – B Ratnapuri 9825918357 12th 25 MBA – Finance
A. Chauhan Appartment, December
Opposite Baranpura 1988
Petrol Pump,
Vadodara

Special Training (if any):

 Tax Planning with reference to new business undertaking.
 Investment Management
 Foreign Currency Risk Management
Your strengths in this field:
 19 months work experience in a pharmaceutical company with regards to
Business Management.
 Brief understanding about the global pharmaceutical industry.

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2. Personal Details:

NAME ADDRESS TELE.NOS DATE OF AGE EDUCATION

BIRTH QUALIFICATION
Mrs. Rajal R. 9537922004 12th 21 MBA – Marketing
Brahmbhatt September
1991

Special Training (if any):

 SAP

Your strengths in this field:

 Understanding of the Market and Competitive Intelligence.

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3. Personal Details:

NAME ADDRESS TELE.NOS DATE OF AGE EDUCATION

BIRTH QUALIFICATION
Mr. Rishi Kale 43, Daulat 9825025727 18th May 34 M. Pharm – The M S
Society, Near 1979 University of Baroda.
Utkatsh High
School,
Vadodara

Special Training (if any):

 Projects Management

Your strengths in this field:

 Wide Experience on New Business Development and Business Strategy.
 Intellectual Property Management.

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4. Personal Details:

NAME ADDRESS TELE.NOS DATE OF AGE EDUCATION

BIRTH QUALIFICATION
Mr. Vinoth G – 180, G – 9677423815 12th January 30 B.E. Mechanical –
Kumar Block, Gate 1984 Indian Institute of
Number 2, Technology, Chennai
Sector 1,
Near Ansal
Plaza, Palam
Vihar,
Gurgaon -
122017

Special Training (if any):

 Energy Management.

Your strengths in this field:

 High expertise in Plant commissioning and Factory Management. He played a

pivot role in Management Team at Vedanta Group for starting and commissioning
facilities in Rajasthan

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5. Personal Details:

NAME ADDRESS TELE.NOS DATE OF AGE EDUCATION

BIRTH QUALIFICATION
Vrusti B. Rao A-40, Ashok 9624094787 11th 22 MBA – Finance
Vatika, VIP September
Road, 1990
Karelibaug,
Vadodara

Special Training (if any):

 Working Capital Management.

Your strengths in this field:

 Understanding of the Import and Export Procedures.

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III. PRESENT STATUS AND MARKET POTENTIAL

1. Basic Market Information about your project

Dose flexibility is a growing need for all segments of the population, especially the
geriatric and pediatric populations. The growth of >65 year old segment has been
outpacing the growth of the overall U.S. population. Over half of all elderly patients are
currently on 3 or more medications and, by 2020, will consume 40% of all prescriptions.
The prescription drug spending for the >65 and for children (0-19 years) is growing at a
faster than average rate compared to other age groups. Individualized dosing to achieve
treatment goals, adherence, cost containment and safety are among the chief concerns of
these age groups.

Dose flexibility can be defined as the ability to easily and accurately deliver dosing
according to a patient’s individual needs. This has important clinical ramifications as health
care providers can customize drug therapy for their patients, titrating doses up and/or
down, and help patients reach their therapeutic goals in many chronic conditions such as
hypertension, hyperlipidemia and diabetes. It also allows physicians and patients to achieve
doses that might not otherwise be available and to make fine dose adjustments. This is
important for medicines with narrow therapeutic indexes, such as anti-coagulants,
medications for cardiovascular and thyroid disorders, and those to treat conditions such as
pain, anxiety and depression. Additionally, as combination therapy becomes more
commonplace, dose flexibility for combination tablets is needed to manage side effects or
to maximize therapeutic response.

Lastly, dose flexibility translates into an efficient use of health care resources -- multiple dosage
strengths can be derived from one tablet, which translates into fewer prescriptions written (if a
medication is being titrated), fewer trips to the pharmacy and to the physician’s office, and
fewer medication refills.

Our technologies represent a solution to the long-standing problem of dose inflexibility. Our
technologies are designed to provide easily divisible tablets that, when subdivided, result in
precise smaller doses for the ease of customized and precise dose adjustments and titration. This

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is achieved through a drug-free break layer that delivers accuracy upon subdivision well within
the existing EP standards for subdivision of scored dosage forms. The technologies can be
applied to any product requiring titration or dose adjustment (e.g. cardiovascular, opioids, anti-
depressants, anti-epileptics). They are especially suited to medications with a narrow therapeutic
index, where precise dosing is of the utmost clinical importance.

2. Existing manufacturers of the products in your local area and their

annual Production / sales turnover: Not Available

3. Expected customers and selected areas: The expected customers and the
selected geographical areas are been shown and will be targeted as per the following
phases.

PHASE - I (NORTH AMERICA)

Particulars Region
Subsidiaries of Indian Pharma Companies United States
Pharmaceutical Companies based in United States United States
Subsidiaries of Indian Pharma Companies Canada
Pharmaceutical Companies based in Canada Canada

PHASE - II (BRAZIL AND EUROPE)

Particulars Region
Subsidiaries of Indian Pharma Companies Europe
Pharmaceutical Companies based in Europe Europe
Subsidiaries of Indian Pharma Companies Brazil
Pharmaceutical Companies based in Brazil Brazil

PHASE - III (MIDDLE EAST AND AFRICA)

Particulars Region
Subsidiaries of Indian Pharma Companies Middle East
Pharmaceutical Companies based in Middle East Middle East
Subsidiaries of Indian Pharma Companies Africa
Pharmaceutical Companies based in Africa Africa

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PHASE - IV (ASIA PACIFIC (EXCLUDING INDIA) AND AUSTRALIA)

Particulars Region
Subsidiaries of Indian Pharma Companies Asia Pacific
Pharmaceutical Companies based in Asia Pacific Asia Pacific
Subsidiaries of Indian Pharma Companies Australia
Pharmaceutical Companies based in Australia Australia

4. Annual Production and market need:

It is estimated that millions of people subdivide tablets every day, either for dose-
adjusting, cost savings or both.

Dose adjustments are a common and everyday occurrence for many patients on acute or
chronic medications. The frequency of dose adjustments varies according to therapy. It is
estimated that as many as 86% of patients taking warfarin, a popular anticoagulant, are on
alternating dosage regimens. Another prime example is statins, the largest prescribed class
of cardiovascular medicines. Currently, there are over 30 million Americans on statins.
Dose adjustments during the first year are frequent as patients are titrated (or dose-
adjusted) according to their cholesterol goals and response to therapy. Even after one full
year of statin therapy, where “dose stabilization” has occurred, 17% of patients still require
up/down dose titration. Oxycodone, a frequently prescribed opioid analgesic, is adjusted
both in the short and long-term. In one study, approximately, 44 percent of patients taking
Oxycodone for the treatment of non-cancer pain, required titration in the first three months,
and 8-13% required dose titration in the longer term (> 1 year).

Tablets, on the other hand, are the most popular dosage form because of the advantages
afforded to both the manufacturer and the patient. They also offer the greatest opportunity
for dose flexibility via the presence of a score mark. It is estimated that over 50% of all oral
dosage forms are produced as compressed tablets. Nonetheless, approximately 15% of
tablets bear a score mark(s), rendering the majority of tablets dose inflexible. Of the tablets
bearing score marks, many of these are more cosmetic rather than functional. According to
the Association of Pharmaceutical Scientists, there are 7 types of score marks, ranging
from the most functional to the purely cosmetic. Most tablets today are the E-Type, or
standard bisect, which are more cosmetic in nature and are not formulated or designed to

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break into equal doses, despite the implication of the score mark. Experts in this field
recommend avoiding the E-type and opting instead for the functional types (D, C or A),
depending on the active ingredient.

The only ways to achieve dose flexibility is via tablet subdivision, multiple dosage strengths or
multiple daily dosages. It is estimated that millions of people subdivide tablets every day, either
for dose-adjusting, cost savings or both. Unfortunately, this practice is not always safe,
regardless of whether the tablets are subdivided using a tablet-splitting device, a knife or by
hand, as tablets break into imprecise doses. Such method is hazardous for the patient as well.

5. Scope for diversification:

As far as diversification is concerned, it will be more based on the markets. As depicted
from the above table, the diversification is slowly happening from targeting the regulated
markets of the world to the non-regulated markets. Gradually five years down the line the
company is also planning to explore the Veterinary segment.

6. Risk factors: The risk factors that have been identified are as follows:
 The growth our business is with the correlation with the growth of the
pharmaceutical industry. Being our technology will be used by the pharmaceutical
companies, it also depends on your plans how they want to capitalize the
opportunities which are available as far as dose flexibility is concerned. Hence
our business is prone to the industry risk.
 Being our undertaking is 100% Export Undertaking Unit, our business is largely
under the domain of the foreign currency risk.

7. Conclusion
On a concluding note, the technology that will be manufactured will not only help the
patients worldwide, but this project is a win – win situation for our company and
pharmaceutical industry where the pharmaceutical industry will get an opportunity to
explore such a lucrative area.

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IV. TYPE OF UNIT AND SITE SELECTION

1. Name of Unit:

2. Address: A – 40, Plot Number B7, Hinjewadi Business Park, Pune, Maharashtra.

3. Type of unit: 100% Export Oriented Undertaking (EOU)

4. Techno Economic reasons for site selection: The following reasons have been
identified for the site selection:
 Availability of Cheap Land.
 Availability of 24 hours Power Supply at subsidized rate from Maharashtra State
Electricity Board having a provision of 220 / 22 KV.
 24 hours Water Supply scheme from Pawana Dam having a provision of 12MLD.
 Close proximity with the vendors for the supply of raw materials.
 Mumbai Port is just 150 KMS away from the facilities.
 Favourable state government policies.
 Easy Availability of unskilled and skilled workers given the state of social
infrastructure.
 Availability of ancillary facilities like Drainage, Fire Stations and the roads.

5. Location of factory and Address: A – 40, Plot Number B7, Hinjewadi Business
Park, Pune, Maharashtra.

6. Requirement of land and Building: The plant and building will be spread in three
hectares (Approximate 322917 Square feet).

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V. PRODUCTION PROCESS
Our technologies represent a solution to the long-standing problem of dose inflexibility. The
patented and patent-pending technologies are designed to provide easily divisible tablets
that, when subdivided, result in precise smaller doses for the ease of customized and precise
dose adjustments and titration. This is achieved through a drug-free break layer that delivers
accuracy upon subdivision well within the existing EP standards for subdivision of scored
dosage forms. The technologies can be applied to any product requiring titration or dose
adjustment (e.g. cardiovascular, opioids, anti-depressants, anti-epileptics). They are
especially suited to medications with a narrow therapeutic index, where precise dosing is of
the utmost clinical importance.

Our (tri-layer) tablets are manufactured in a deep fill multi-layer press. In the AIA version
(figure 1), “A” can be a single or combination agent drug which is separated by a drug-free break
layer, allowing the dose to be divided into exact halves. In the AIB version (figure 2), “B” can be
a different drug or drug combination which is likewise separated by a drug-free layer, allowing

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the two medications to be easily separated from each other if medically indicated. The novel AIB
design is especially suited for combination products with compatible and/or incompatible APIs.
The technology can also be applied to controlled-release formulations, offering unprecedented
flexibility for CR products – either for pure CR tablets or in combination CR and immediate-
release (IR) tablets, as shown in figure 3.

This is especially important as many CR medications are available as capsules or unscored tablets,
unsuitable for subdivision. Even for CR medications in scored tablet form, multiple studies have
documented that the pharmacokinetic properties are altered when CR tablets are subdivided. The
tablets for single agent drugs are manufactured on a standard bi-layer press and can be produced as
bisected, trisected, or quadrisected tablets, rendering exact half, third or quarter doses (figure 4).

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Additionally, other configurations can be achieved such as pentasect or octasect tablets, should the
need arise (figure 5).

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The Manufacturing services will be as follows:

 Manufacturing.
 Engineering Services.
 Warehousing.
 Supply Chain.
 Process Engineering.
 Effluent Treatment Plant.
 Quality Control.
 Quality Assurance.

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VI. PROJECT IMPLEMENTATION SCHEDULE

Start
Sr.No Name of Activity Weeks Date End Date
Product Selection and Completion of Market
1 Survey 6 18-08-13 29-09-13
2 Project Report Preparation 2 29-09-13 13-10-13
3 Site Selection 6 29-09-13 10-11-13
Loan Application for Fixed Assets and Working
4 Capital 4 06-10-13 03-11-13
5 Machinery orders to be placed 2 03-11-13 17-11-13
6 Building for factory to be ready 80 10-11-13 24-05-15
Installation of the Machinery/ Electrical
7 connections 24 10-11-13 27-04-14
8 Power Connection 6 13-04-14 25-05-14
9 Recruitment & Training of Manpower 52 03-11-13 02-11-14
10 No load trails/ Flushing of lines/ Connection 6 25-05-14 06-07-14
11 Commissioning 8 06-07-14 31-08-14
12 Sales Arrangements 4 17-08-14 14-09-14
13 Commercial Production ongoing 01-09-14 goes on

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VII. ORGANIZATION STRUCTURE

PROMOTERS

PRESIDENT

VP – HUMAN VP - FINANCE VP – BUSINESS VP - VP – SUPPLY VP –

RESOURCES DEVELOPMENT MANUFACTURING CHAIN R&D

GENERAL GENERAL GENERAL GENERAL GENERAL GENERAL

MANAGER MANAGER MANAGER MANAGER MANAGER MANAGER

SENIOR SENIOR SENIOR SENIOR SENIOR SENIOR

MANAGER MANAGER MANAGER MANAGER MANAGER MANAGER

MANAGER
MANAGER MANAGER MANAGER MANAGER MANAGER

ASSISTANT ASSISTANT ASSISTANT ASSISTANT ASSISTANT ASSISTANT

MANAGER MANAGER MANAGER MANAGER MANAGER MANAGER

EXECUTIVE EXECUTIVE EXECUTIVE EXECUTIVE EXECUTIVE EXECUTIVE

TRAINEE TRAINEE TRAINEE TRAINEE / TRAINEE TRAINEE

WORKERS

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VIII. POLICIES ON IT, HRM AND INNOVATION

A. POLICY ON HRM:

This policy encompasses those guidelines which constitute a sound basis for efficient and
effective HR Management in our organization. They are in essence flexible and dynamic and
may require adjustment to a variety of circumstances. Therefore its implementation will be
inspired by sound judgment, compliance with local market laws and common sense, taking into
accounts the specific context. Its spirit should be respected under all circumstances. Also to be
considered is the degree of development of each market and its capacity to advance in the
management of their human resources.

These policies are addressed to all those who have a responsibility in managing people as well as
to HR professionals. The Company’s Management and Leadership Principles include the
guidelines inspiring all the employees in their action and in their dealings with others. The
Corporate Business Principles refer to all the basic principles which we endorse and subscribes
to on a worldwide basis. Both these documents are the pillars on which the present policy has
been built. The pillars of our HRM policy are based upon:

 A shared responsibility.
 Dealing with people.
 Work Life Balance.
 Best Remuneration.
 Professional Development.
 Industrial Relations.

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B. POLICY ON INNOVATION:

Innovation is critical to the transformation of any economy. Study after study shows that
innovative companies grow faster, are more profitable, and add more employees than those who
are not innovative. States, regions and localities interested in economic development are
increasingly turning to innovation and entrepreneurship strategies to revitalize their economies.
Our Innovation policy has the following pillars:

 Starving for the next S curve.

 Lean on customers.
 Think like a designer.
 Lead the way.

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C. POLICY ON IT:

We recognize that E-mail usage and access to the Internet are valuable in business
communication and research which, when used wisely, can provide significant benefits to the
organization. However, it is important to note that there are legal, ethical, security and
productivity issues involved when using E-mail or accessing the Internet. For these reasons, all
communication (including by telephone, facsimile and computer facilities) should reflect the
standard of professional conduct and ethics that the person would otherwise maintain as a
member of our organization.

Policy Statement – E-mail and Internet Usage:

E-mail and Internet activities are to be confined to organization’s business related activities.

The Internet and E-mail system hardware is Company property and therefore all messages sent
or received on the E-mail system are and remain Company property. They are not the private
property of any employee/representative.

The Organization will not tolerate E-mail usage or Internet access for inappropriate or illegal
purposes. Inappropriate E-mail messages waste time and may place individuals in an
embarrassing or even legally compromising position. All employees/representatives should
understand that internal and external E-mail messages are records of our organization that may
be required for business or legal reasons. Moreover, transactions using E-mail or the Internet
reflect the person's identification with our organization. E-mail and Internet communication
originating from our organization employees or representatives must never contain
inflammatory, harassing or defamatory language, and must not be disruptive to the operations, or
convey any material which would reflect poorly on the organization’s reputation or its general
public image.

Individuals must not use another person’s personal computer (PC) or access code / password to
access the Internet or on-line services, without the prior permission of that person. Individuals
must not retrieve or read any E-mail messages that are not sent to them without prior
authorization. Individuals must not connect to personal Internet or on-line services using
Company property.

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