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RANBAXY PHARMACEUTICALS

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ACKNOWLEDGEMENT

As one self can accomplish nothing, this report is not an


exception. We would like to have some space to
acknowledge some of them that frequently fade in to
background.

I am thankful to Mr. Vinod K. Mishra (H.R. Manager)


and Mr.Pankaj Badlani for giving me this opportunity
to complete my Organization Study.

I express my heart full thanks to Dr.P.K.Jain, QC


Manager and Mr.T.C. Jaiswal, QA Manager for his kind
support and guidance.

I extend my deep gratitude to Mr.R.S.Thakur for


providing necessary resources and worthwhile
suggestion.

I thank the staff of Swift Formulation, Indore for their


concern, kind co-operation and help towards the
successful completion for project.
Date:
Place:

KINSHOO SHAH

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CONTENTS

1. ACKNOWLEDGEMENT
2. INTRODUCTION
3. ORGANIZATION STRUCTURE
4. SWOT ANALYSIS
5. MARKETING FUNCTION
6. HUMAN RESOURCE FUNCTION
7. FINANCE FUNCTION
8. FUTURE PLANS
9. CONCLUSION & RECOMMENDATIONS

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INTRODUCTION

Science is facts: Just as houses are made of stones, so is sciences


made of facts: But a pile of stones is not a house and collections of fact are
not necessarily science.
An industry is an organization based on the principle of associated
effort and refers to complete body including all its correlated functions.
The sudden acceleration of the technical and economic
development resulted from the expansion of industrial society.
The main objective of any industry is to bring about the
conversion of raw material, the manufacturing of goods and the provision of
services. Industry can be either low technology, unspecialized or labor
intensive, as in countries with a large unskilled labor force as highly
mechanized and specialized, using advanced technology as in the
industrialized countries art of this pharmaceutical industry is the rapidly
expanding industry.

PHARMACEUTICAL INDUSTRY:
Pharmaceutical Industry mainly relies on the production
for drug and the use of sophisticated equipments this industry developed
by gradual steps from very early times from the age of dispensing
pharmacy to the large scale industry.
A pharma industry is engaged in the production, marketing
and distribution of pharmaceuticals. It may also involve in the research &

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development works. In this industry FDA policies and good manufacturing


practices are followed.

RANBAXY PHARMACEUTICALS

Ranbaxy Laboratories Limited is India's largest pharmaceutical


company. Incorporated in 1961, Ranbaxy exports its products to 125
countries with ground operations in 46 and manufacturing facilities in seven
countries. It is ranked among the top 10 generic companies worldwide. The
CEO of the company is Malvinder Mohan Singh.

History of Organization:

Ranbaxy was started by Ranjit Singh and Gurbax Singh in


1937 as a distributor for a Japanese company Shionogi. Interestingly the
name Ranbaxy is a portmanteau word from the names of its first owners
Ranjit and Gurbax. Bhai Mohan Singh bought the company in 1952 from his
cousins Ranjit Singh and Gurbax Singh. After Bhai Mohan Singh's son
Parvinder Singh joined the company in 1967, the company saw a significant
transformation in its business and scale. His sons Malvinder Mohan Singh
and Shivinder Mohan Singh sold the company to the Japanese company
In 1998, Ranbaxy entered the United States, the world's largest
pharmaceuticals market and now the biggest market for Ranbaxy,
accounting for 28 %; of Ranbaxy's sales in 2005.

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DEWAS PLANT OF RANBAXY LABORATORIES

Dewas plant of RANBAXY LABORATORIES LIMITED started


in 1832.Over a period of times it has expanded into four production
blocks.This plant occupies a proud place in Indian Pceutical Industry.
Over the years this plant has grown into a place for quality
medicines used in India & abroad . Reputation of this plant can be judged
from the fact that this
Plant has various approvals from international regulatory authorities like:

US - FDA
MHRA - UK
TGA - AUSTRALIA
MCC - SOUTH
ANVISA BRAZIL
WHO GENEVA
FDA CANADA
Dewas plant of RANBAXY can be broadly divided into two
parts; one is the Pceutical formulation & other small bulk drug plant.

The formulation block mainly comprises of:


BLOCK A Semi Synthetic Penicillin (SSP) BLOCK
BLOCK B - The block for general tablets.

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BLOCK C The Cefalaxin Block.

COMPANY: AN OVERVIEW

HIGHLIGHTS:

Indian Multinational Company.

Products being regularly exported to more than 70 countries.

Own marketing offices in 23 countries.

Marketing tie-ups in 17 countries.

Intensive distribution network.

Global employment of approx. 9000 people.

Manufacturing operation in 7 countries.

Contemporary in regulatory compliances.

Eco-friendly.

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R & D spend approx. 5% of sale (largest in India).

PROFILE OF PRODUCTS

Using the finest R&D and Manufacturing facilities, Ranbaxy


Laboratories Limited manufacture and markets generic pharmaceuticals,
value added generic pharmaceuticals, branded generics, active
Pharmaceuticals (API) and intermediates.
Healthcare trends project that the chronic treatment segments will
outpace the acute treatment segments, primarily driven by a growing aging
population and dominance of lifestyle diseases. Our robust performance in
Cardiovascular, Central Nervous System, Respiratory, Dermatology,
Orthopedics, Nutritionals and Urology segments, clearly indicates that
the Company has strengthened its presence in the fast-growing chronic and
lifestyle disease segments.

Top Ten Molecules


Simvastatin
Amoxy+Clav Potas Com
Amoxycillin
Ciprofloxacin
Isotretinon
Cephalexin
Ketorolac Tromethamine
Cefaclor

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Clarithromycin
Cefuroxime Axetil
Finished Drugs:

Acyclovir
Cefprozil
Cefuroxime Axetil
Cephalexin
Ciprofloxacin HCl
Clarithromycin
Fenofibrate
Fluconazole
Fosinopril Sodium
Fosinopril Sodium and Hydrochlorothiazide
Gabapentin
Ganciclovir Sodium *
Glimepiride
Isotretinoin
Lamivudine
Loratadine (OTC)
Metformin HCl
Nefazodone HCl
Nitrofurantoin; Nitrofurantoin and Macrocrystalline
Ofloxacin
Pravastatin Sodium
Ranitidine
Simvastatin

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Terazosin HCl
Valacyclovir HCl
Zidovudine (PEPFAR)

Active Ingredients:

Clarithromycin
Valacyclovir HCl
Pravastatin Sodium
Acyclovir
Ciprofloxacin HCl
Ganciclovir Sodium *
Gabapentin

* Products not affected by Import Alert.

VISION & ASPIRATIONS

The Company is driven by its vision to achieve significant business


in proprietary prescription products by 2012 with a strong presence in
developed markets. It aspires to be amongst the Top 5 global generic players
and aims at achieving global sales of US $5 Bn by 2012.

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IMPORTANT STRATEGIES

Ranbaxy is focussed on increasing the momentum in the generics


business in its key markets through organic and inorganic growth
routes.
It continues to evaluate acquisition opportunities in India, emerging
and developed markets to strengthen its business and
competitiveness.
The Companys growth is well spread across geographies with near
equal focus on developed and emerging markets.
Ranbaxy has entered into new speciality therapeutic segments like

Bio-similar, Oncology, Peptides and Limuses. These new growth


areas will add significant depth to its existing product pipeline.

RESEARCH & DEVELOPMENT

Ranbaxy continued its strong research orientation in the area of


generics and new drug discovery.

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New Drug Discovery Research (NDDR)

Ranbaxy made significant progress on its Anti-malarial molecule


by successfully completing Phase II studies of its combination product
Arterolane in India and Thailand. The Company received approvals from the
Drug Controller General of India (DCGI) to commence Phase III studies in
adult and Phase II studies in pediatric patients. The Phase III trials will soon
begin in India.
The Company also plans to seek regulatory approvals in South
East Asian countries and Africa for Phase III clinical trials. Ranbaxy's
collaborative research programs with GlaxoSmithKline (GSK) are
progressing well. The Company started a Phase I Rising Single Dose study
in India on one of the candidates in the respiratory segment. With the
beginning of the Phase I clinical trial, Ranbaxy received a milestone
payment from GSK. Ranbaxy also filed a Clinical Trial Application
(CTA) for the same with the National Medical Agency, Romania, for
conducting Phase I clinical trials in Romania.
Three additional programs, covering the Oncology and
Inflammation areas have also been included in the GSK alliance. Ranbaxy
signed an alliance with Merck for the discovery of novel Antibiotics and
Antifungal drugs. Under the alliance, the focus is to screen, identify and
optimise new lead compounds for activity against an identified novel target
for hospital acquired gram-positive infections.
In collaboration with Anna University, India, the Company has
identified a plant extract that shows significant activity in the in vivo models
of pain and inflammation. In addition, the Company is pursuing

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collaboration with the International Centre for Genetic Engineering &


Biotechnology (ICGEB), India, profiling the Anti-dengue activity of a
plant extract, through a funding from Department of Biotechnology (DBT).
Ranbaxy is also working on two Anti-tuberculosis targets with
similar support from the DBT. During the year, the Drug Discovery team
filed nine patents and Herbal Research team filed two patent applications in
India.

ORGANIZATION STRUCTURE

Executive Team
The Executive Committee is an apex body at Ranbaxy that
oversees Company's global functioning. The group deliberates on important
Company issues steering it in the right direction. The Committee ensures
that all decisions are taken in the best interest of the organization. This
forum brings in different perspectives on a subject. Issues are discussed,
analyzed and concluded through exchange of ideas, reflecting the
Company's philosophy of participative management. It also facilitates the
Company's compliance with the best standards of Corporate Governance.

Mr. Vinod K. Mishra, H.R. Manager

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Mr. Pankaj Badlani


Dr.P.K. Jain, QC Manager
Mr. T.C. Jaiswal, QA Manager
Mr. R.S. Thakur

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PROJECT MANAGER for individual projects

A project manager is a professional in the field of project


management. Project managers can have the responsibility of the
planning, execution, and closing of any project, typically relating to
construction industry, architecture, computer networking,
telecommunications or software development.
Many other fields in the production, design and service industries also
have project managers.

Overview

A project manager is the person accountable for accomplishing the


stated project objectives. Key project management responsibilities include
creating clear and attainable project objectives, building the project
requirements, and managing the triple constraint for projects, which is cost,
time, and scope.

A project manager is often a client representative and has to


determine and implement the exact needs of the client, based on knowledge
of the firm they are representing. The ability to adapt to the various internal
procedures of the contracting party, and to form close links with the
nominated representatives, is essential in ensuring that the key issues of cost,
time, quality and above all, client satisfaction, can be realized.

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QUALITY ASSURANCE

This department is setup for the testing of the materials and final
products. Three types of tests are performed.
1. Chemical test

2. Physical test

3. Biological test

Chemical test is done on raw materials and materials in process.


Biological are performed on selected materials. Physical tests are done to
test flexibility, elasticity, plasticity etc.

Quality Control Programme


The quality control department has a quality control program for
the three products. There are three stages in the quality control programme.
Receiving Inspection covers the quality testing of all the items purchased.
There is an In Process Testing for all the product intermediates. Finally the
finished products are tested for destabilization.
Results of all the quality control tests are recorded. The records
are stored for a period of 8 years from the month of manufacture.
The Quality Objectives are listed below.
To reduce stock out situation by 75% on engineering items.

To dispatch the items within 24 hours/ latest by next day/ or as per


delivery scheduled by the marketing department.

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SWOT ANALYSIS
KEY STRENGTHS

Leadership in Novel Drug Delivery System (NDDS) products, which

offer value-added differentiation over conventional products. Key


brands include Cifran OD (Ciprofloxacin), Zanocin OD (Ofloxacin)
& Sporidex AF (Cephalexin).
Strong brand building capabilities, reflected in the fact that 20

brands feature in the Top-300 brands of the Industry list. The


leading 5 brands are Sporidex (Cephalexin), Cifran (Ciprofloxacin),
Mox (Amoxycillin), Zanocin (Ofloxacin) & Volini (Diclofenac).
A well-built customer interface, with one of the highest customer

coverage across India, and an excellent franchise with both


Generalists & Specialists. This is proven by Ranbaxy Indias
Corporate Image being perceived as Best-in-Class by customers.
Great emphasis is placed on Knowledge Management and Medico-

marketing initiatives such as Advisory Board Meetings, Post


Marketing Surveillance Studies and Continuous Medical Education
programs. These have resulted in an excellent customer relationship
with the medical fraternity. More than 2000 interface programs
(Symposia, CMEs) are conducted and about 20 Clinical Papers
published annually.
With a futuristic approach, the India operations attempts to capitalize
on the fast- emerging, high-growth segments with innovative products
and services:

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Biological formulations such as Verorab (Rabies Vaccine) and


Vaxigrip (Flu Vaccine), which require competencies to
propagate the newer concepts in the market place. These
products are being in-licensed or taken on Co-promotion from
Sanofi Pastuer.
High end anti-infectives such as Cilanem
(Imipenem+Cilastatin) & Faronem (Faropenem) have been
launched for the first time in India. Ranbaxy is championing
the concept of Penems/ Carbapenmens.
Dry Power & Metered Dose Inhalers have been launched in
the Respiratory segment. All Metered Dose Inhalers are HFA
based formulations, environment friendly inhalers. It is for the
first time in India, that a company has launched its entire HFA
propellant based MDI range. The worlds first novel product,
Osovair (Formoterol + Ciclesonide) inhalation capsules has
been introduced in the Indian market.
Anti-diabetic franchise has been further consolidated with
launch of Insucare (Insulin) with an innovative delivery
mechanism - Controlled Insulin Logistics This ensures that
the cold chain, vital for product efficacy, is maintained.
A slew of products have been launched in the Dermatology
segment:
Suncross (Sunscreen lotion), Sotret (Isotretnoin), Eflora
(Eflornithine).

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WEAKNESS

The United States Food and Drug Administration on Tuesday banned


the import of more than 30 generic drugs manufactured by Ranbaxy
Laboratories Limited alleging that poor quality control at the firm's
factories could be harmful to users of these medications used to treat
everything from high cholesterol to Type 2 diabetes to everyday
allergies.
Among the drugs banned from Ranbaxy are the popular generic for
the antibiotic Cipro to the generic for the cholesterol reducing Zocor
and Metformin, the generic used for the treatment of Type 2 diabetes
to the popular allergy fighting generics for Claritin and Alavert.
FDA issued two warning letters to Ranbaxy and an import alert for
generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants
in India.
The letters identify the agency's concerns about deviations from US'
current Good Manufacturing Practice requirements.
The problems at these two Ranbaxy plants relate to deficiencies in the
company's drug manufacturing process. These actions are proactive
measures that the FDA is taking in order to assure that all drugs that
reach the American public are manufactured according to cGMP
requirements.

FDA's inspection, in early 2008, of Ranbaxy's Dewas facility found:

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The facility's beta-lactam containment program (measures taken to


control cross-contamination), which appeared inadequate to prevent
the potential for cross-contamination of pharmaceuticals;
Inadequate batch production and control records;
Inadequate failure investigations; (A failure investigation is done to
address any manufacturing control or product rejection to determine
the root cause and prevent recurrence); and,
Inadequate aseptic (sterile) processing operations.

OPPORTUNITIES

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The global spread of Ranbaxy and the blazing growth in business


provides ample opportunities for employees to build careers in
various fields.
Opportunities have never been a constraint for the deserving. They
believe in employee growth that goes beyond vertical movements and
change in designations. Potential and performance are the pillars of
career progression at Ranbaxy. A robust development process
supports this.
The managers will generally have the opportunity to live and work in
different countries; such international experience will help them
better understand the complex business and grow both personally and
professionally.

THREATS & CHALLENGES

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Ranbaxy's focus is to develop new drugs to fill the gaps and take
advantage of Ranbaxys strong areas.
To overcome its current challenges in cost structure and supply
chain, Ranbaxy's primary aim is to establish a management
framework that will expedite synergies. Having done that, the
company seeks to reduce its exposure to branded drugs in a way that it
can cover the impact of margin pressures on the business, especially
in Japan.
In a global pharmaceutical industry making a shift towards generics
and emerging market opportunities, acquisition of Ranbaxy signals a
move on the lines of its global counterparts Novartis and local
competitors Astellas Pharma, Eesei and Takeda Pharmaceutical.
Post acquisition challenges include managing the different working
and business cultures of the two organizations, undertaking minimal
and essential integration and retaining the management independence
of Ranbaxy without hampering synergies.
Looking ahead at 2009, apart from the on-going challenges in the US,
with the FDA as well as the abnormal rupee and global Forex
movements, Ranbaxy also has to cope with a global depression
scenario.

MARKETING FUNCTION

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DOMESTIC MARKET:
Market share 5%.
Products portfolio contains 17 of top 300 brands Of India.
Therapeutic Width 68% of the market.
Doctors' coverage over 180 thousands.
Products distributed through 4000 stockist & 200 thousand retail
outlets.
Retail outlets coverage 90%.

SOME OF THE COUNTRIES TO WHICH THE PRODUCTS ARE


EXPORTED:

Australia
Austria
Belgium
Bangladesh
Brazil
China
Cambodia
Congo
Canada
Denmark
Dominican Republic
Egypt
Ethiopia

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France
Finland
U. S. A.
U .K.

PRODUCT PROMOTIONAL MEASURES

The following measures are undertaken by the company for


promotion of their products:

A.) ADVERTISING:
Medical Representatives are appointed to approach doctors,
druggists & chemists & publicize products.
Distribute pamphlets, calendars, diaries, notepads etc to doctors,

chemists & laboratory scientists other customers.


Display hoardings & posters.
Issue advertisements in newspapers & magazines in the favor of
public health welfare.
Produce commercial ads to be telecasted on T.V. & Radio.

B.) EVENTS:
Organize Seminars for introduction of new products.

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Conducts meets & conferences of doctors, pharmacists,


druggists, and research & lab scientists as promotional campaign.
Sponsor Seminars & Conferences.
Organize health care & clinical check up camps & programs to
earn name & fame.

C.) OFFERS & SCHEMES:


Offer various facilities, gifts hampers, discounts, commissions
etc. to doctors & pharmacists for prescribing their drugs to patients.
Run schemes on products to develop public interest & attract
customers.

D.) PUBLIC SURVEYS:


Conduct surveys to understand public compliance & know the
areas of improvement.
Public relations help in earning goodwill.
Surveys help to know the most beneficial means of advertising.

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HUMAN RESOURCE FUNCTION

HR VISION

Fostering employee excellence in support of building the Nations


best Health Care Company.

HR MISSION

To provide companywide leadership in formulating human resource


policies and programmes that enhance the quality of employee
services and encouraging employee contributions towards sustaining
HLLs continued excellence.

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To collaborate with all other departments in supporting effective

recruitment, development and maintenance of a highly competent


workforce.
To be a strategic partner in creating a work environment, which

fosters individual achievements, teamwork, integrity, professionalism


and accountability.
To foster a meaningful, environmental friendly and productive work
environment and ensure positive contribution to the community
around us.

HR OBJECTIVES

Exercise leadership in modeling and implementing successful human


resource policies and practices that help unleash employee potential.
Create an organizational ambience where talents can bloom and
support the managements efforts to foster a high performance
workforce.
Support local efforts to recruit, develop and retain a highly qualified

work force by building market practices and effective employer


practices into human resource methodologies.
Encourage, support, reward and recognize creativity, innovation,

individual and team performance.


Provide competitive terms and conditions of employment to the work
force through building up a reward and recognition mechanism that
provides value for people.

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Main functions of the Human Resource Department:


-Manpower planning
-Recruitment and selection

-Training and development

-Industrial relations

-Promotion and transfer

-Trade union

-Workers Participation

-Employee- Welfare Benefit

-Mentoring

-Key Performance Indicator

LIFE AT RANBAXY

A career at Ranbaxy means an opportunity for ample learning &


growth. It offers avenues to work across the globe alongside the finest
minds. The Company offers
a challenging assignment,
a world class working environment,
professional management,
competitive salaries,

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Stock options along with exceptional rewards.

PERFORMANCE APPRAISAL: Salary and Benefits

Salaries and other benefits in Ranbaxy are comparable with the best in
the industry and one can expect to be rewarded highly if the performance is
consistently outstanding.
Group Life Insurance, Medical Insurance and Pension plans
are a few examples of the benefits provided to the employees and their
dependents with adequate financial protection on long term basis.

STOCKOWNERSHIP

The ownership in business is fundamental to personal progression,


they encourage one to take ownership of his investments.
Stock ownership is a part of the compensation for the managers
early in their career at Ranbaxy.

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FINANCE FUNCTION

Ranbaxy further consolidated its business in India despite an overall


slowdown. While the overall domestic market registered a growth of 10.3%
(MAT Nov 2008), Ranbaxy grew by 13.9%.
The Company recorded sales of US $ 299 Mn. Maintaining its
strong position in India, Ranbaxy was ranked No.2 with a market share of
5.08%. Ranbaxy continued its dominance in metro Class I and IA tier cities
(top 500 cities/towns of India) with the highest market share amongst all
companies (5.47% share in Sep 08 MAT).
The Company's Chronic business segment that contributes around
25% tothe business grew faster than the market registering 18.4% growth.
In the Cardiovascular therapy area, Ranbaxy registered an even higher
growth of 26.5% against 14.9% growth for the segment (MAT Nov 2008).
In the Acute therapy area, Ranbaxy grew by 12.6% against the market
growth of 9%. The Company continued its leadership position in Anti-
infectives, Ranbaxy's major therapeutic segment, with a buoyant 14.7%
growth (MAT Nov 2008).
Ranbaxy today holds leadership positions in many product
categories across therapies with 19 brands in the top 300 products list, out of
which 5 are in the top 30 and 10 are in the top 100 (MAT Nov 2008).

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Some of the leading brands include the Cifran range, Sporidex,


Zanocin, Mox, Faronem, Cilanem from Acute therapy and Storvas,
Pioglar G, Rosuvas, Synasma, Flotral and Niftran from the Chronic
therapy segment.
During the year, Ranbaxy realigned its operations to cater to the
demand in the high growth pharmaceutical segments. The structuring of
domestic operations is in line with customer groups and high growth
potential markets. This has resulted in the further strengthening of its
Chronic franchise and has reinforced the Company's leadership position in
the Acute therapy segment.
Ranbaxy also capitalised on innovative products in the niche fields
of Intensive Care, Urology, Aesthetic Dermatology, Oncology and Bone
Disorders. In 2008, Ranbaxy successfully launched a number of molecules
in the Acute and Chronic therapies, of which many were 'Firsts' in the
country. One such example in the Urology segment was a Novel Drug
Delivery Systems (NDDS) product, Contiflo ICON (Tamsulosin OD tablets
0.4 mg) for patients suffering with Benign Prostate Hyperplasia.

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FUTURE PLANS

After facing massive losses coupled with regulatory hurdles in the


American market, Ranbaxy Laboratories Ltd has chalked out plans to
revamp its US business.
Ranbaxy CEO and Managing Director Malvinder Mohan Singh stated

that company's focus will be to resolve regulatory compliance issues


and continue to strengthen cGMP (certificate for good manufacturing
practice) across all locations.
For the year, 2009, Ranbaxy has a clear strategy to harness its growth

potential in the emerging markets, rebuild the US business through a


series of actions on products and facilities.
Focus on monetizing the FTF opportunities and launching niche new

products will enable the company to drive the growth in the US


business.
There is of course also great scope in the usage of Ranbaxy resources
and skills in R&D, Manufacturing and Supply Chain and many
specialist functions (eg IT, IP).

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