COMPANY PROFILE

Medley is a global pharmaceutical company operating since 1969 from Mumbai, India. Since
launch, the company consolidated its position with a strong manufacturing and marketing
infrastructure.

Medley has state of the art facilities maintaining high quality standards at every further stage in
manufacturing process with strict adherence to the Good Manufacturing Practices (GMP).

Medley Pharmaceuticals Limited is a multidivisional and multi location organization with strong
presence in Pharmaceutical formulations. The specialties include Hematinics, Anti ulcerants,
Anti bacterials, Pain management, Gynecology & cardiovascular drugs. We specialise in Iron
preparations, our mega brand being [Link] Syrup. We also have many 1st time in India
brands to our credit like Dompan (Domperidone & Pantoprazole), O2 (Ornidazole & Ofloxacin),
Tazocef (Tazobactum & ceftriaxone) & Ostium k2 (1st brand of Vitamin K27 combination in
India)

Medley employs more than 3000 people , of which approximately 2200 are part of the sales
force , around 700 associates in corporate & manufacturing across India & 100 in International
Business.

Medley ranks amongst the top 40 pharmaceutical companies in India as per ORG IMS.

Medley believes that quality is a continuous process and not an isolated stage in the process.

We have an extensive distribution network across the country with 6 Depots, 17 C/Fs & over
1800 stockists which caters to the retailers.
 TRIBUTE TO OUR FOUNDER
• “Success is driven by Passion, Energy and Positive thinking “

• “Successful Managers make happen what will not normally happen”

• “It is Volition and not Motivation that leads to Performance”

Late Chairman Mr. Sami Khatib (1934 – 2014).

Born in the sleepy hamlet of Kalamb (district Yavatmal, Maharashtra State) to a well known
Landowner, he was the youngest of nine siblings. He Left home at a tender age in his quest for
education, that took him across towns and cities including Mumbai. His multidisciplinary
academic achievements earned him the degrees of BSc, BPharm, LLB & DBM. The University
of Mumbai, The Laxminarayan Institute of Technology, The Government Law College Nagpur
and The Jamanalal Bajaj college of Management were among his Alma Mater.

Fresh out of college and a visionary by nature he began charting a course in the pharmaceutical
industry After gathering a few years of work experience he plunged headlong as an entrepreneur
into a difficult and competitive industry. In 1969, with only his ambition as seed capital, he
founded a nascent enterprise that he christened “Medley Laboratories”.

Those were difficult years. The pharmaceutical industry was dominated by Multinational
corporations. The business was capital intensive and financially challenging. Armed with a
modest loan of ₹200,000 under the Technician- Entrepreneurs scheme of The Maharashtra State
Finance Corporation, with unflinching support from his wife Mrs. Sima Khatib and driven by a
determination to succeed, Mr. Sami Khatib faced and headed off several challenges to get a
toehold in a tough industry. Over the years his keen business acumen, dynamic spirit and
entrepreneurial capacity saw his company, now “Medley Pharmaceuticals Ltd.” grow into a
sizeable entity in the industry.

Mr. Sami Khatib was quickly recognized as among the founders of the “Indian Pharmaceutical
sector”. On 6th March 1991 he was awarded the Vijay Ratna by the Prime minister of India.
Besides, he was invited to serve on the Drugs Advisory Committee of the Government of India
during 1996 - 1999.

Mr. Sami Khatib was a keen philanthropist and devoted a considerable portion of his time and
resources to fulfill his social responsibilities. His charitable trust “The Sinkhai Foundation”
contributed to basic and higher education as well as to the healthcare of the economically weak
sections of society.

He actively participated in managing leading educational institutions like Anjuman- I- Islam

from 1987- 2012 during which he also served as its President. Besides, he served as Chairman of
Maharashtra College 1998-2003, and as Chairman of Kamala Nehru College of Pharmacy,
Aurangabad 1981-1987.

Mr. Sami Khatib’s mantra for success was high involvement and hard work. He fostered an
inclusive and open style of management and remained in the saddle until the very end. His
exemplary commitment to his endeavors, fair dealings and resolute steadfastness are his legacy
for future generations to emulate.

CHAIRMAN’S MESSAGE
 “Integrity in Medicine”, which is part of the company logo reflects basic value of Medley. Medley is in the
business of building brands by promoting the products ethically.

What started as a small operation as first generation enterprise with a Medley

of three diverse products about 45 years back is now present in the nook &
corner of India with 5 divisions in different specialties. In addition Medley
products are marketed actively in 24 countries of South East Asia, Africa, Middle East, CIS
and Europe.

Medley has entered into the highly regulated market with its UK MHRA approved facility and
proceeding with approvals from MCC of South Africa and ANVISA of Brazil. The Company
is on the verge of entering into USA market after getting due approvals from its authorities. The
buzzword in Medley is innovation which benefits the ultimate consumer. Thus Medley has been
able to launch many innovative products in the country for the first time; O2, Dompan, Nimsaid
P, Ostium K2, Telmed AH, Nortipan are few of them. Some brands of Medley like O2,
Ostium K2, R.B. Tone, Eva Q, Nortipan are leaders in the respective segments as per ORG
IMS.

Currently Medley has 3000 strong devoted employees. It has set up a Research Center in
Mumbai and an API unit at Tarapur near Mumbai. Medley is proud to be a place where people of
different caste, creeds, races, religions come together and work in an environment of intense
competition but with dignity. We have good number of women working in the managerial
positions and a woman is occupying the director position in the top management. Medley will
ensure that this is maintained in the future with no gender bias in the Company. Indians from all
the states of India, speaking different languages are working in Medley not only in the field but
also in the factories and corporate office.

Medley is passionate in pursuing Corporate Social Responsibility (CSR) activity. Most of the programs are executed through
a NGO, Sinkhai Foundation not just by giving donations but actually participating in the entire process. In order to provide
medical assistance at affordable price, the NGO has established 4 full-fledged Charitable Diagnostic Centres named “SINKHAI
CHARITABLE DIAGNOSTICS”. A High School in a remote cluster of villages near Yavatmal has been constructed and
managed actively. Similarly about 500 students receive scholarships in various professional education disciplines every year. The
main thrust in Medley's CSR is education.

OUR VISION
MILESTONE
First manufacturing operation in Aurangabad in 1976 for tablets, capsules and liquid orals.
Second unit established in 1992 at Daman for liquid orals.
Third unit at Daman established in 1998 for tablets and capsules which was later dedicated to
Cephalosporin formulations.
Fourth unit established at Daman in 2000 for large volume liquid orals.
Fifth unit established at Daman in 2002 for tablets and capsules complying with international
regulatory requirements.
Medley was accredited as ISO - 9001 : 2000 company during the year 2003, by American
Quality Assessors (AQA).
Largest Brand R. B. Tone is number 2 in haematinic segment as per ORG-IMS.
Brand O2 launched in 2005 is number 1 in the antidiarrhoeal segment as per ORG-IMS.
A large manufacturing complex in Jammu in 2005 spread over 12.5 acres of land.
State of the art R&D centre established at Daman which has received approval of Department
of Science and Technology, Govt. of India in 2006.
Medley received the well deserved accolade "WHO GMP Certificate".
Manufacturing sites are approved by WHO for 120 products and Regulatory Agency of 10
other countriesfrom the rest of the world.
Export to 26 countries in South East Asia, Africa, Middle East, Russia & CIS.
2010-UK-MHRA Accreditation of Daman manufacturing unit.
2014-UK-MHRA Accreditation of Daman manufacturing unit.
2017-USFDA Accreditation of Daman manufacturing unit.
2015- Nortipan received the Silver award for being the best New introduction - AWACS
AWARD FOR MARKETING EXCELLENCE on 7th Oct 2015

INFRASTRUCTURE
Daman Plant
 The plant is located on plot No. 18 & 19, Zari
causeway road, Kachigam, Daman. This facility is
located about 5 km away from Vapi railway station &
about 179 km from Mumbai.

The plot size is 7602 sq. mtrs, and the construction

area is 7335 sq. mtrs. It has dedicated and segregated
areas meeting current cGMP requirements for
manufacturing of oral dosage forms - Tablets,
Capsules & Liquid orals. Adequate areas for storage of Raw materials, Packing materials &
Finished products has been provided.

The manufacturing capacity per annum in single shift is 5100 lac Tablets & capsules and 46 lac
litres of liquid orals. The facility is WHO GMP and Schedule M GMP certified by the Indian
FDA. The facility is also approved by National Drug Authority of Uganda, MOH Sudan,
Tanzania, Malawi and Yemen. The Facility is MHRA-UK and USFDA approved and scheduled
for other highly regulated agencies MCC-SA and WHO-Geneva.
Jammu Plant
The plant is located at Lane-3, Phase I, SIDCO
complex, Bari Brahmana, Jammu. This facility is
about 20 Kms away from the Jammu Airport. The plot
size is 53115 [Link] and total construction area is
15981 sq. mtrs.

It has dedicated and segregated areas meeting current

cGMP requirements for manufacturing of oral dosage
forms - Tablets, Capsules & Liquid orals.

Adequate areas for storage of Raw materials, Packing materials & Finished products has been
provided. The manufacturing capacity per annum in single shift is 8040 lac Tablets and capsules
and 31.80 lac litres of liquid orals.
Tarapur Plant
Tarapur facility is designed for production, processing
and control of APIs. It is situated in the chemical zone
of the MIDC - Boisar, Tarapur in Thane district of
Maharashtra, INDIA.

Total reaction volume : 44.7 KL (Total Reactor Volume)

Total plot area : 19690 Sq. m.
Production facility area : G.F - 1179.6 Sq. M., 1st & 2nd Floor-1038.77 Sq.M.
Laboratory area : 332.1 Sq. M.
Warehouse facility : 1609 Sq. M.

API Manufacturing capability

Multipurpose two manufacturing block with capacity to manufacture small, medium and large
volume product.

State of Art Facility having Two independent Modules of Powder Processing Area A & B.
Facility is equipped with Glasslined Reactors and Stainless Steel Reactors to handle
acidic/alkaline reactions, capacity ranging from 500liter to 5000liter to cater versatile batch sizes.
Followed by Charcoalization, crystallization, and centrifuge in Powder Processing Area.
Equipments like RCVD, VTD, Blender, Shifter & Jet Mill are available for further Powder
Processing.
We have Clean Room Area with Terminal HEPA Filter Complying 100000 class HVAC system.
Multipurpose facility for manufacturing under cGMP.
Two independent modules.
Both modules can take care for multistep synthesis.
Reaction temperatures range -20 to 200 deg C.
Halar coated centrifuges for acidic products.
100% power backup for plant through own generation.
Q.C , Q.A and regulatory team to ensure cGMP compliance.
Full safety system in place.

Medley is poised to actively participate in this growing opportunity of outsourcing and contract
manufacturing.

Services:
Generic APIs
Contract Manufacturing
Contract Research
Custom Synthesis
Intermediates Manufacturing

Zero Discharge Effluent treatment plant

Environment protection, safety and Health are integrated right.
So in a world, where environment threats such global warming is becoming threat to mankind
we, at Medley Pharmaceuticals feel it is our responsibility and commitment to work for pollution
free world.

The Technical and Physical manufacturing capabilities exist with us for the selected APIs and
their intermediates. However those products will be offered only to the markets where any
product or process patents are not infringing. During the validity of a patent the research
quantities for developing products for regulatory submissions will only be offered to countries
where such exemption exists (Hatch Waxman Act / Bolar exemption). While Medley offers to
work with the clients on Patent Status Verification, the final responsibility vests with the buyer.
Recipients are requested to make their evaluation and determination as to the patent status prior
to their use of the information or materials in their respective jurisdiction.

Products under patent offered only for exempted research, clinical and development purposes.
Only non-infringing products and processes are offered, subject to patent status verification by
client.
Medley Pharma Limited, UK
Medley Pharma Limited (UK Company), a wholly
owned subsidiary of Medley Pharmaceuticals Limited
(Indian Company) is Liverpool, UK based company
having focus on marketing activities in regulated
market of United Kingdom. It is established in 2014
and belongs to 40 licenses for generic drugs and also
deals in various OTC and specials products.

CORPORATE SOCIAL RESPONSIBILITY

Medley firmly believes in their corporate social responsibility. An essential component of our
corporate social responsibility is to care for the community, the society and the environment. We
endeavour to make a positive contribution to the underprivileged sections of our society by
supporting a wide range of socio-economic, educational and health initiatives. Our commitment
to address important societal needs extends through our philanthropic outreach programs driven
through a NGO Sinkhai Foundation Trust.

Besides focusing primarily on the welfare of economically and socially deprived sections of
society, we believe that education is the best chance children can get to grow and develop to their
full potential in life. Thus a high school in the remote cluster of villages near Yavatmal has been
constructed & managed actively. The foundation works relentlessly to ensure improvement of
general health and sponsor underprivileged students to pursue professional courses. About 1000
students receive scholarship in various professional education disciplines every year.

Second objective is to provide affordable healthcare services. Slums are the birth place of
various diseases and early diagnosis is the key to control and cure those diseases. But, due to
high cost of diagnostic tests most of them are unable to bear the high cost of diagnostics thereby
making the illness more complicated.

In order to provide Medical assistance for early diagnosis , MEDLEY PHARMACUETICAL

LTD under its Corporate Social Responsibility (CSR) established a full-fledged Charitable
Diagnostic Centre named “SINKHAI CHARITABLE DIAGNOSTICS” at Sakinaka
Andheri(E), Behram Baug Jogeshwari(West), Malwani Malad (West) and Jogeshwari (East).
The unique feature of this Charitable Diagnostic centre is that it has Modern Digital X-Ray
Facilities, Ultrasonography and Complete Pathology Testing. It aims to provide such services in
various parts of Mumbai, Thane and nearby area by setting up Charitable Diagnostics Centre in
different slums where the need prevails.

Medley firmly believes to move beyond business & touch every heart and fuel a billion dreams.

SUPRAKARE
Suprakare is the 2nd biggest divison of Medley catering mainly to Orthopaedic &
Gastroenterology segments. It is also the fastest growing division of Medley & has one of the
most innovative and first time launches in the Indian Pharmaceutical Market like DOMPAN
(Domperidone plus pantoprazole), Ostium k2 ( 1st brand of Vitamin K27 combination in india),
Tazocef (Tazobactam plus Ceftriaxone), Acenac-N (Aceclofenac plus Pregabalin) to name a few.
Today, all of them feature amongst the top 5 brands in their respective segments.
COLLABORATION
Collaboration is Key to Our Success
Collaboration, cooperation and partnership are the keys to our success. We are committed
to working with our corporate partners to offer our research, development, regulatory,
manufacturing, marketing and sales expertise. Identifying good partners and managing long-term
relationships is part of our company philosophy.
Contract Manufacturing
Why Medley for Contract Manufacturing?
Medley understands the outsourcing requirements of its customers and transforms their
needs into solutions. The pharmaceutical industry today is facing challenging business
environment due to escalating R&D and manufacturing costs as well as delays in bringing new
drugs to market.
Other key factors impacting the industry include:
 Ever increasing demands to deliver lower cost of goods (CoGs) and improve customer
supply performance
 Greater product complexity
 Ongoing regulatory compliance demands
By using our contract manufacturing services you can access Medley's comprehensive
technology portfolio for pharmaceuticals and the competence we have built up over decades.
Knowledge, modern technology and creativity combined with clear and well-defined
communication procedures between our teams of experts and customers & above all consistency,
world class quality & delivery ahead of time are the key factors for achieving optimum solutions
that will surely exceed your expectations.
Complete confidentiality and protection of client intellectual property is the heart of the Medley
culture.
In-Licensing
We look at partnering and collaborating as an important strategic approach that will complement
our growth in India and international markets.
We believe in brand building & are leaders in various therapeutic segments with 3 brands
featuring in top 300 (IMS-Health). Our extensive distribution network with more than 1500
stockists, 6 depots & 16 C&F’s backed by 40 years of marketing experience & strong field force
of over 1500 representatives enables us to achieve the leadership position in various therapeutic
segments. We use collective experiences and resources that have been proven to work at the
highest levels of efficiency to help brands better succeed. Our core areas of marketing expertise
include the gastroenterology, cardiovascular, diabetology, gynaecology & orthopaedic therapy
areas.
We seek to establish a long term, mutually rewarding relationship based on exclusive marketing
rights business model, as well as co-marketing or strategic alliances for co-development
including clinical trials of products for necessary regulatory approvals.
Out-Licensing
Our formulation development expertise enables us to develop generic products which are
bioequivalent.
We seek out-licensing opportunities for our generic formulations for global markets.
Our Global Services
 Formulation development
 Contract manufacturing of generic formulations for European market
 Analytical method development and validation
 Extensive QC capabilities (Micro, Chemical, ICH Stability)
 Packaging and shipping

WORLDWIDE OPERATIONS

Medley has set its eyes on becoming a truly global pharmaceutical company over the next
decade. Medley's products reach 24 countries with significant presence in Asia, Africa, Middle
East, Russia and CIS Medley intend to enhance its International presence based on its policy of
"Integrity in Medicines" and quality of products. Medley already has setup the office in UK and
tied up with partner in USA and SA.

Medley is aggressively working on finalizing its business tie-ups in Brazil. Medley has dynamic
team and representative office in Vietnam, Myanmar, Cambodia, Sri Lanka, Kenya, Russia,
Kazakhstan Kyrgyzstan and Tajikistan. The dynamic field force promotes its speciality
formulations. Around 514 formulations are registered in 26 countries. Today International
business contributes 16% of Medley sales, but expected to grow substantially in the next three
years. We have three manufacturing facilities, Daman, Tarapur and Jammu which strictly
follows.

All our manufacturing facilities are the state of art manufacturing units for oral and liquid
section. The Daman Facility is MHRA-UK approved. One of our facilities at DAMAN is
certified for Good Manufacturing Practices (GMP) Conforming to INTERNATIONAL
STANDARDS by Competent Regulatory Authorities in Uganda, Sudan, Tanzania, Malawi,
Ethiopia, Yemen and Ivory Coast. Medley is now preparing for the South African.
This initiative of Medley would help strive for the growth and to serve the world community
R&D
The inbuilt quality of products is assured through scientific way of product development at R&D
scale, transfer of technology from lab scale to mass production, analytical method development,
stability studies and process validation.

Our current thrust is towards development of innovative dosage forms in the areas of tablets,
syrups, aerosols & herbal formulations.

We believe that only through integrity one can provide the best medicine to patients whose well
being is valued the most.

Medley has established state of the art R&D Centre at Mumbai equipped with the latest ultra
modern instruments. The R&D centre have highly experienced team of scientists having post
graduate and doctorate degrees in the field of pharmacy and chemistry.

SAFETY REPORTING
Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases;
however, there are also risks particularly adverse drug reactions (ADRs) that can cause serious
harm to patients. ADRs are common, frequently preventable cause of illness, disability and
death. An ADR may be defined as “an appreciably harmful or unpleasant reaction, resulting from
an intervention related to the use of a medicinal product, which predicts hazard from future
administration and warrants prevention or specific treatment, or alteration of the dosage regimen
or withdrawal of the product”.

Thus, for safety of medication, ADR monitoring is required for each medicine throughout its life
cycle i.e. during development of drug such as pre-marketing including early stages of drug
design, clinical trials and post-marketing surveillance. Pharmacovigilance (PV) plays a key role
in the healthcare system through assessment, monitoring and discovery of interactions amongst
drugs and their effects in human.

The adverse events reported by PV system will potentially benefit to the community due to their
proximity to both the population and public health practitioners.

Therefore, with a goal to ensure benefits of use of medicine and to safeguard the health of the
Indian population, we have decided to monitor ADRs in Indian population. All the regions across
the country (India) where Medley Pharmaceuticals Pvt. Ltd. markets its medicines are involved
in reporting ADR in the prescribed form (ADR form).
REPORTING OF ADR
If you are a healthcare professional/consumer and wish to report an adverse event which has
occurred by treating patient /using any of our products, you can opt any of the following
procedure to report an adverse event:

Download Adverse Event Reporting Form and send via any of the below mentioned method of
communication,
Fill available information, Scan and e-mail the completed form to pv@[Link]
Send the completed form through post to our corporate office:
Medley Pharmaceuticals Ltd.D-2, MIDC Area, Andheri (E), Mumbai- 400 093
Submit the completed form through our authorized company representative
You can call us between 9 am to 5 pm on any working day* on +91-8104640495

*Please note that, we are closed on Saturday, Sunday and Public Holidays.

For more information on PHARMACOVIGILANCE, you can write us at pv@[Link]