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Ranbaxy Laboratories Ltd. (RLL) is the largest pharmaceutical company incorporated in India.

It is
also amongst the top league globally and is ranked 9th largest generic company worldwide. Ranbaxy
is also credited with the tag of true Indian multinational. The company traces its roots to a chemist
shop in Delhi. It is one of the first Indian pharmaceutical company to start a joint venture abroad.
Rapid growth of Ranbaxy is attributed mainly to its focused research and joint ventures in India and
abroad. It is also innovation and market driven, with a strong distribution network. The company was
able to grow successfully in highly competitive markets. In the current business scenario, Ranbaxy is
focusing on innovation, alliances, mergers and globalisation to achieve its long-term vision of
becoming a global pharmaceutical giant with a turnover of $1 billion by 2004. The fruits of such
efforts are evident in the latest financial result, as a large chunk of its income comes from new
products and exports of generics. The growth of Ranbaxy can be attributed to its ability to identify
good windows of opportunity and its ability to grow by leveraging innovation, regulatory knowledge
and alliances.
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.
The Company remains focused on ascending the value chain in the marketing of pharmaceutical
substances and is determined to bring in increased revenues from dosage forms sales.
Ranbaxy's diverse product basket of over 5,000 SKUs available in over 125 countries worldwide,
encompasses a wide therapeutic mix covering a majority of the chronic and acute segments.
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 Cardiovasculars, 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 20 Molecules
AmoxiClav Potassium
Amoxycillin and Combinations
Ciprofloxacin and Combinations
Ketorolac Tromethamine
Omeprazole and Combinations
Cefuroxime Axetil
Loratadine and Combinations
Diclofenac and Combinations
Cefpodoxime Proxetil
Atorvastatin and Combinations
Ofloxacin and Combinations
Research & Development

Ranbaxy views its R&D capabilities as a vital component of its

business strategy that will provide the company with a sustainable,
long-term competitive advantage. The company today has a pool of 1,200 scientists who are engaged
in path-breaking research.
The robust R&D environment within the company for both drug discovery & development reflects the
Company's commitment to be a leader in the generics space and offer value added formulations based
on the Company's Novel Drug Delivery System (NDDS) and New Chemical Entity (NCE) research
The NDDS research at Ranbaxy focuses on maximizing the overall therapeutic and commercial value
of commonly prescribed pharmaceutical formulations by enhancing their performance and reducing
their adverse event profile. Such innovation also helps to improve the overall patient convenience and
The company's NDDS focus is mainly on the development of New Drug Applications (NDA) /
Abbreviated New Drug Applications (ANDAs) of oral controlled- release products for the regulated
markets. The Company's first significant international success using the NDDS technology platform
came in September 1999, when Ranbaxy licensed its once-a-day Ciprofloxacin formulation on a
worldwide basis to a multinational Company.
Ranbaxy's in-house NDDS programs are primarily focused on the oral segment. Inhalation (patented
devices) and trans-dermal (patented adhesive polymers) programs are also being pursued through
In the oral NDDS space, Ranbaxy has already developed four platform technologies namely Gastro
Retentive, Modified Matrix, Multiparticulate and AeroGel. Several products leveraging these
technologies have been successfully developed.
The Companys NDDR program focuses on select therapeutic segments of Infectious diseases,
Metabolic diseases, Inflammatory/ Respiratory disease and Oncology. Presently, the Company has 810 programs in the area of NDDR.
For Arterolane (potential Anti-malarial candidate), the Company has obtained approval from the Drug
Controller General of India to initiate Phase III human clinical trials in India. Ranbaxy plans to seek
regulatory approval in other countries outside India to the Phase-III clinical trial.
The Companys potential drug candidate for Dyslipidemia RBx 10558, has been successfully outlicensed to Pharmaceutical Product Development Inc. (PPD), a leading global Contract Research
Organization for clinical development for further development.
The Company is also profiling DPP-IV Inhibitors (Di-Peptidyl Peptidase IV Inhibitors) for Type-2diabetes, a selective Phosphodiesterase 4-b inhibitor for COPD and Asthma, and a novel antibiotic
antibacterial for Community Acquired Respiratory Tract Infection.
The Company continues to forge ahead with its various research alliances, in order to expedite its
Drug Discovery program.

Significant progress has been made on two research programs, one each in the Anti-infective and
Respiratory segments, which are being pursued with GlaxoSmithKline (GSK). Consequently,
Ranbaxy and GSK have expanded the original agreement and Ranbaxy now has the responsibility for
advancing the selected compounds to proof of concept in man, whereby total milestone payments,
excluding royalties, could exceed over US $ 100 Mn.
Under an alliance with a leading academic institution in India, a number of medicinal plants are being
evaluated as potential sources for novel pharmaceutical agents. The Company also has collaborative
research projects with other academic institutions in India in the area of Respiratory and Infectious
Ranbaxy is among the few Indian pharmaceutical companies in India to have recognized the
importance of Research & Development (R&D) and invested early in it. The first research activity at
Ranbaxy was initiated way back in the year 1973. Later when Ranbaxy drew its ambitious global
plans, it embarked on R&D in a significant way by establishing its first R&D centre in 1994.
Ranbaxy today has state-of-the-art multi-disciplinary centre at Gurgaon (near New Delhi) in India,
with dedicated facilities for generics research and innovative research.
The prowess of Indian scientists is widely acknowledged today and it is believed that the cost of
developing a new drug in India can be one third to one fifth of doing the same, in the developed
world. It is a long term objective of Ranbaxy to build a proprietary prescriptions business, based on its
prowess in NDDS and NCE research.
Worldwide Operations
Global Pharma Companies are experiencing an ever changing landscape ripe with challenges and
opportunities. In this challenging environment Ranbaxy is enhancing its reach leveraging its
competitive advantages to become a top global player.
Driven by innovation and speed to market we focus on delivering world-class generics at an
affordable price. Our unwavering determination to achieve excellence leads us to new global
benchmarks. Our people have consistently risen above all challenges maximized opportunities and
positioned Ranbaxy as a leader in the global generics space.
Ranbaxys global footprint extends to 49 countries embracing different locales and cultures to form a
family of 51 nationalities with an intellectual pool of some of the best minds in the world.

The Ranbaxy Laboratories Limited - SWOT Analysis company profile is the essential source for toplevel company data and information. Ranbaxy Laboratories Limited - SWOT Analysis examines the
companys key business structure and operations, history and products, and provides summary
analysis of its key revenue lines and strategy.
Ranbaxy Laboratories (Ranbaxy), the largest generic pharmaceutical company in India, is engaged in
the manufacture and trade of formulations, active pharmaceuticals ingredients (API) and
intermediates, generics, drug discovery and consumer health care products. It also focuses on research
and development activities primarily in India. The company operates in India, Europe, North America
and Asia Pacific. It is headquartered in Gurgaon, India and employed 8,536 people as of December
2008. The company recorded revenues of INR76,919.8 million ($1,776.1 million-) during the
financial year (FY) ended December 2008, an increase of 11.2% over FY2007. The operating loss of
the company was INR2,626.3 million ($60.6 million-) during FY2008, as compared with an operating
profit of INR10,509.4 million ($242.7 million-) in FY2007. The net loss was INR9,512.1 million
($219.6 million-) in FY2008, as compared with a net profit of INR7,745.9 million ($178.9 million-) in
FY2007. - Calculated using the constant currency conversion rate of INR1 = $0.02309 for the
financial year ended December 2008
Scope of the Report
- Provides all the crucial information on Ranbaxy Laboratories Limited required for business and
competitor intelligence needs
- Contains a study of the major internal and external factors affecting Ranbaxy Laboratories Limited
in the form of a SWOT analysis as well as a breakdown and examination of leading product revenue
streams of Ranbaxy Laboratories Limited
-Data is supplemented with details on Ranbaxy Laboratories Limited history, key executives, business
description, locations and subsidiaries as well as a list of products and services and the latest available
statement from Ranbaxy Laboratories Limited
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FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs
from Two Ranbaxy Plants in India
Actions affect over 30 different generic drugs; cites serious manufacturing deficiencies

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories
Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas
and Paonta Sahib plants in India.
The Warning Letters identify the agency's concerns about deviations from U.S. current Good
Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and
Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the
violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S.
border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished
drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy
facilities and offered for import into the United States.
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. While this action
does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has
shipped defective products. We will continue to monitor the situation.
Today's announcement does not impact products from Ranbaxy's other plants which are not affected
by today's actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP
requirements for drug manufacturing.
The FDA recommends that consumers continue taking their medications manufactured by Ranbaxy
and not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned
about their medications should discuss their concerns with their health care professional.
Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two
facilities and the plants come into compliance with U.S. cGMP requirements, FDA's drug compliance
office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated
New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the
manufacturer of APIs or finished drug products
Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company
makes a number of drug products.
The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in
multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two
locations.FDA has evaluated whether these actions would create any potential drug shortages in the
United States, and has determined that other suppliers can meet market demand, with one exception.
Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an
antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of
this product, and plans to arrange for additional oversight and controls until the company resolves
these manufacturing issues.
"With this action we are sending a clear signal that drug products intended for use by American
consumers must meet our standards of safety and quality," said Janet Woodcock, M.D., director,
FDA's Center for Drug Evaluation and Research (CDER). "The FDA has notified other agencies and
health care professionals to make them aware of today's actions so that they can take appropriate
action and advise patients as needed." The Warning Letters issued today document the results of FDA
investigations at these two sites.
One Warning Letter addressed problems at Ranbaxy's Dewas facility found during an inspection
conducted by FDA in early 2008. During that inspection, FDA investigators documented significant
cGMP deviations in the manufacture of sterile and non-sterile finished products and violations with

respect to the manufacture and control of APIs. Specific areas of concern included the following
aspects of the firm's quality control program:

The facility's beta-lactam containment program (measures taken to control crosscontamination), 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.

The second Warning Letter addressed the Paonta Sahib facility following an inspection at its
Batamandi unit, also in early 2008.This inspection documented various cGMP deficiencies, including
the following:

The lack of assurance responsible individuals were present to determine the firm was taking
necessary steps under cGMP;
Inaccurate written records of the cleaning and use of major equipment;
Incomplete batch production and control records; and,
Inadequate procedures for the review and approval of production and control records for drug

Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for
each of the facilities. In mid-April and May, Ranbaxy responded in writing to these findings in
lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy's responses, and the
firm's overall inspectional history, an evaluation that required substantial time due to the complex
scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and
the firm's responses. Ultimately, FDA concluded that the firm's responses were not adequate and that
the Warning Letters were the appropriate regulatory response.
"Today's actions are clearly warranted by the serious violations established by FDA's investigations at
these two sites," said Deborah M. Autor, director, CDER's Office of Compliance, FDA. "Until the
company addresses these deficiencies, APIs and finished drug products from these plants will remain
on the Import Alert, and we will not approve any Abbreviated New Drug Applications or New Drug
Applications that list either of the two facilities as the manufacturer of APIs or finished drug
This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy.
In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.
The FDA will continue to work with Ranbaxy's Dewas and Paonta Sahib plants to resolve these
Consumers and health-care professionals can report adverse events to FDA's MedWatch program at
1-800-FDA-1088; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 208529787; or online, at the following Internet address:
Introduction - Business Opportunities with Ranbaxy: Core Competencies

Ranbaxy Pharmaceuticals Inc. (RPI) has already experienced

commercial success penetrating the U.S. health care market, and is
looking to enhance growth and future business opportunities
through collaboration and strategic alliances.
Ranbaxy Pharmaceuticals Inc. (RPI) is a product-driven
pharmaceutical company with diversified expertise. As a wholly
owned subsidiary of Ranbaxy Laboratories Limited, Indias largest
pharmaceutical company, RPI offers an advantage of having a
global presence with experience in more than 125 international
The companys advanced product development and manufacturing capabilities, combined with a
global sales and marketing network, make RPI an attractive business partner. A key part of RPIs
business strategy is to collaborate with partners with complementary skills a mutually beneficial
strategy for both parties.

API Development and Production

Ranbaxy can provide Active Pharmaceutical Ingredients (API) for companies that want to
manufacture their own product or brand without incurring the time and costs associated with
developing the API, eliminating this step from the overall manufacturing process. Key advantages of
using Ranbaxy's vertically integrated system are:
Continuity of supply
Consistent quality of product
Competitive costs
Flexibility and resources to respond to changing market dynamics
Dosage Form Development and Manufacturing
Ranbaxy's experience as a global manufacturer makes it an ideal partner to take on the complex
process of solid or liquid dosage form development. Ranbaxy continually uses reverse engineering to
improve upon its development and manufacturing processes and enhance yield, with a focus on
achieving greater cost efficiencies.
Contract Manufacturing
To expand product lines with minimum investment, Ranbaxy provides turnkey manufacturing

services, including API and dosage form development, to allow companies to focus on marketing and
selling the product. This is an efficient way to diversify product lines and increase profit margins,
taking advantage of Ranbaxy's manufacturing capabilities and expertise.
Sales and Marketing
Ranbaxy has set itself apart in the marketplace through the rapid expansion of its product line and its
willingness to emulate complex drug formulations. RPI's commitment to quickly expanding the
breadth and depth of its product line has been key to its success in the marketplace.
Ranbaxy has a commercial advantage as many of the high-profit branded drugs with expiring patents
over the next few years are in the categories where Ranbaxy has proven expertise - anti-infectives,
gastrointestinal, cardiovascular and analgesics.
RPI has a turnkey marketing group that works with other pharmaceutical companies to co-market and
co-promote a variety of chemicals and products. As a marketing partner, RPI is able to meet the
marketing needs of companies while they themselves focus their efforts on a drug's development,
manufacturing, distribution and sales.
Marketing Strategies
Marketing Strategies is the department focused primarily on developing and executing strategies for
the promotion and distribution of branded, generic and OTC products for RPI.
One of the key tasks for the department is to identify opportunities in different markets and
distribution channels and pursue those to developing and establish new relationships in the
marketplace. Managed Care and Internet marketing are a couple of key areas that the department is
looking to introduce into its ever-expanding service offerings.
RPI prides itself on taking a creative, mutually beneficial approach to licensing arrangements. The
company is open to exploring both outward and inward licensing opportunities to fulfill unmet needs
in the marketplace.
Ranbaxy is the first company in India to master the highly specialised process formulations of
enrofloxacin and enrocin.
Ranbaxy eyes growth in animal healthcare
Girish Singhal
RANBAXY Laboratories Ltd (Ranbaxy) is planning to capture a significant portion of the Rs. 900crore domestic animal healthcare (AHC) business in 2000.
The company has chalked out a growth plan for its AHC division to be achieved through the launch of
a range of new products which are now not marketed in India. These new products will be aimed at

prevention and cure of diseases in various animals. For t his, Ranbaxy is in talks with leading
multinational companies for possible alliances in the near future.
``The AHC division of Ranbaxy was started on a small scale in the year 1984 and has gradually risen
to a level where it contributed Rs. 35 crores to the company's topline in the year 1999,'' a company
official told Business Line. The official declined to give details regarding new products to be
launched by the company and the proposed partner with whom the company is planning a joint
venture in this regard.
The division has introduced several latest veterinary pharmaceutical formulations in the recent past
enabling a sales growth of 38 per cent and 28 per cent in last two years. It now manufactures various
formulations including Enrocin, BMD-100, Famitone, Albac and Hivit.
While Enrocin is an anti-bacterial drug for poultry and livestock, BMD-100 is a feed supplement for
poultry that was introduced for the first time in India by Ranbaxy in collaboration with the US-based
Alpharma. Hivit is a multivitamin injection primaril y meant for livestock. It combines water-soluble
and fat-soluble vitamins in a single vial.
The company sees tremendous potential for growth in its AHC division as the domesticated animal
population in the country today comprises 220 million cattle, 80 million buffaloes, 110 million goats,
50 million sheep, five million dogs, two million camels and one million horses among others.
The industry's feed requirement is considerable as the livestock sector and the poultry sector consume
2.5 million tonnes and seven million tonnes of compounded feed respectively each year.
`No plans for healthcare insurance'
Ranbaxy has denied media reports saying it was planning a joint venture with the US-based Cigna
Corporation for entering healthcare insurance business in the country.
``The company has no plans to enter the business of healthcare insurance in India or elsewhere.
Accordingly, Ranbaxy has no plans whatsoever for any joint venture or alliance in any way whether
with the US-based Cigna Corporation or with any other insura nce company or entity in the world,'' a
company release said. (
Financial Daily
from THE HINDU group of publications
Thursday, June 01, 2000)

Indication Chronic Respiratory Disease(CRD),
Bronchopneumonia,Cholera,Typhoid,Paratyphoid,Colibacillosis,Colisepticaemia etc.
Composition Each ml contains :
: 100mg
Dosage Canine: N/A Sheep N/A
Poultry * For prevention of bacterial infections, ENROCIN oral should be administered orally,
@5mg per kg b.wt. for 7-10 days.
* For tretment of acute bacterial infections, ENROCIN oral should be administered orally @ 10mg
per kg b.wt. for 3-5 days or as directed by Registered Veterinary Practitioner. In Salmonella spp.
infection the duration of treatment may be extended upto 5 days.

Large Animals N/A Others N/A Administration

Oral Advantages
* ENROCIN has excellent antimicrobial and pharmacokinetic properties which open up new
dimensions in the therapy and prophylaxis of infections caused by bacteria and Mycoplasmas in
clinical and practical veterinary medicine.
* ENROCIN oral is highly effective against common poultry pathogens- Salmonella,E.coli and
* ENROCIN oral is the drug of choice both for the prevention and treatment of CHronic Respiratory
Disease(CRD) complex, complicated by, Mycoplasma spp. infection.
* ENROCIN is free from side effects after oral administration at therapeutic dose rates.
* ENROCIN does not have any immunosuppressive effect.
* ENROCIN , due to its special mechanism of action exhibits no parallel resistance to anti-infective
agents, therefore, it is also effective against organisms which are reistant to Beta-lactum antibiotics,
Tetracyclines, Aminoglycosides etc.
* ENROCIN can be used safely in combination with other drugs, including coccidiostats.
* ENROCIN is a new anti-infective agent developed by Ranbaxy Research Laboratories especially
for veterinary use.