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November 08

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Oglemilast designed for lack of emesis as a side effect ... plagued by psychoactive side effects while CB2 may be devoid of this side effect ... – PowerPoint PPT presentation

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Title: November 08


1
  • November 08

2
Safe Harbour Statement
This presentation has been prepared by
Glenmark. The information, statements and
analysis made in this presentation describing
companys objectives, projections and estimates
are forward looking statements and progressive
within the meaning of applicable security Laws
and Regulations. The analysis contained herein
is based on numerous assumptions. Actual result
may vary from those expressed or implied
depending upon economic conditions, government
policies and other incidental factors. No
representation or warranty, either expressed or
implied, is provided in relation to this
presentation. This presentation should not be
regarded by recipients as a substitute for the
exercise of their own judgment
3
Content
Glenmark A Snapshot
The Evolving Pharma Value Chain
Re-organisation of Glenmark
Glenmark Pharmaceuticals Ltd. (GPL)
R D - H1 Highlights Program Details
SBU - H1 Highlights Road Map
Operations H1 Highlights Near Future Plans
Financials Projections
Glenmark Generics Ltd. (GGL)
SBU - H1 Highlights Road Map
Operations H1 Highlights Near Future Plans
Financials Projections
Glenmark Consolidated Financials
4
Glenmark -A Snapshot
5
Year 2000
Turnover - USD 38 Mn 2 Formulations
Manufacturing Facilities Operations in 27
countries Sales from International operations
8 Initiation into NCE research
Glenmark -A Snapshot
Year 2008
Research Based
Global
  • One of the leaders in drug discovery amongst
    Indian companies
  • 13 New molecules under development with 6 in
    clinics
  • Over USD 110 Mn of cash recd. from NCE
    out-licensing deals
  • Further milestones worth over USD 600 Mn

Integrated
  • Operations in over 95 countries with more than 20
    subsidiaries
  • Over 5500 employees across 5 continents
  • 11 manufacturing facilities in 4 countries
  • Front-ends in key markets worldwide
  • 3 API plants
  • 8 Finished dosage plants
  • 6 research facilities

6
Rapid Changes in Global Scenario The evolving
Pharma Value Chain
Proprietary/ Branded Business
Key Requisites- Innovation Brand
Building Pull for products Marketing front
ends
VALUE CHAIN
Branded Generic Companies will either transition
up the value chain towards Proprietary
business OR They will transition to the other end
towards pure generic business
Branded Generic Business
Key Requisites- Low costs low margins Forging IP
challenges Push for products Efficient
Distribution
Pure Generic Business
7
The Re-organisation of Glenmark Separate focus
on both business domains Proprietary Generics
GLENMARK
Effective April 2008
GLENMARK PHARMACEUTICALS LTD (GPL)
GLENMARK GENERICS LTD (GGL) (A subsidiary of the
parent co.)
  • Specialty/ Proprietary Business
  • Focus on New Drug Development and branded
    products market
  • Pure Generics Business
  • Focus on marketing of APIs and generic
    formulations

8
GPL GGLCurrent Infrastructural Support In
line with Business Requirements
1 dosage plant Czech Republic
Biologics RD - Switzerland
Clinical RD Oxford UK
1 API plant -Gujrat, India
1 dosage plant -HP, India
1 dosage plant -Maharashtra, India
Generics RD -India
Formulations RD-India
NCE RD-India
3 dosage plants -Goa, India
1 dosage plant -Brazil
2 API plants Mtra, India
Clinical Research Unit- Mtra, India
1 dosage plant -Argentina
9
GPL GGLClearly Demarcated Focus Areas
Business Imperatives
In past 6 six months, GPL and GGL have
successfully progressed as Independent Entities
10
GPL Span of Operations
GPL
11
GPL Pioneering Transformation by Transitioning
from Branded Generics domain to Innovation-led
proprietary biz. domain
Clinical RD Oxford UK
IPM, Regulatory, Global BD- USA
Biologics RD - Switzerland
  • Establishing Global Centers of Excellence
  • Small Molecule Research in India
  • Biologics Research in Switzerland
  • Clinical Research in Oxford UK
  • Intellectual Property Management, Regulatory
    Global Business Development USA

NCE RD-India
12
RD H1 Highlights
  • Clinical Research Centre established in Oxford,
    UK. Aims to be the best-in-class set-up in
    Clinical Operations, Biometrics and
    Pharmacovigilance
  • Initiated Phase IIb Asthma and COPD studies on
    Oglemilast (GRC 3886)
  • Melogliptin (GRC 8200), a treatment for type II
    diabetes, completed phase IIa and is currently
    undergoing phase IIb studies
  • Completed Phase 1 trials on GRC 4039, a drug
    being pursued for RA and other inflammatory
    conditions
  • GRC 10693, a CB2 agonist targeting various pain
    conditions, initiated phase I trials in EU
  • Filed the companys first IND (Investigational
    New Drug Application) with the US FDA through GBR
    500, a monoclonal antibody, after successfully
    completing pre-clinical studies
  • Eli Lilly, Glenmarks partner for GRC 6211,
    suspended further clinical development of the
    molecule in Osteoarthritic pain

13
Progress on pipeline A Snapshot
  • New Chemical Entities
  • New Biological Entities

Further OA clinical development suspended
One NCE 3 NBEs are in discovery stage
14
Program Oglemilast (GRC 3886 )
15
Oglemilast (GRC 3886 ) Strengths of the Program
  • Strengths of the program-
  • Potential first-in-class opportunity
  • Disease modifying properties of PDEIV inhibitors
  • Validated pathway in respiratory disease
  • No emesis is seen, unlike other compounds of its
    class. Hence larger therapeutic window
  • Oral, once daily dosing, provides compliance
    advantage

16
Oglemilast (GRC 3886 ) Key Differentiator from
other compounds in class Lack of Emesis
Previous PDE4i which went through late stage
development suffered from low efficacy and side
effects related to emesis
  • Oglemilast designed for lack of emesis as a side
    effect
  • Possibility to escalate doses and achieve higher
    efficacy

Dose Emetic effect in ferrets
17
Oglemilast (GRC 3886 ) Clinical Development
Update
Clinical Development
Both COPD study and Asthma study are progressing
well
18
Program Melogliptin (GRC 8200)
19
Melogliptin (GRC 8200) Strengths of the Program
  • Strengths of the program-
  • DPP IV is one of the most promising treatment
    pathway to come up in the large and growing
    diabetes market - Current analyst estimated
    market size is over USD 35 Bn by 2015
  • GRC 8200 has the potential to be best in- class
    in terms of safety and efficacy
  • Initial data suggests possibility for better
    efficacy than other competing DPP4s
  • Validated development pathway
  • Currently being developed as monotherapy as well
    as combination therapy with other anti-diabetic
    molecules

20
Melogliptin (GRC 8200) Potential to be
best-in-class
  • Amongst the most potent molecules in DPP-IV class
  • High specificity for DPP-IV
  • Potential to have high efficacy in comparison to
    other molecules in class (most have low HBA1C
    reduction levels)

21
Melogliptin (GRC 8200) Clinical Development
Update
Clinical Development
22
Program GRC 6211
23
Program GRC 4039
24
GRC 4039 Clinical Development Update
Clinical Development
25
Program GRC 10693
  • Strengths of the program-
  • Potential first-in-class opportunity
  • Broad application of CB2 can be explored in
    indications such as Rheumatoid Arthritis,
    Multiple Sclerosis, Atopic Dermatitis, ALS
  • Highly efficacious in pain models

26
GRC 10693 Highly specific for CB2 over CB1
High efficacy in pain models
CB1 vs CB2 CB1 agonists (Narcotics such as
Morphine, Codeine) are well established
analgesics but are plagued by psychoactive side
effects while CB2 may be devoid of this side
effect
  • In-Vivo Efficacy Model
  • GRC 10693 High efficacy levels compared to
    Gabapentin
  • Compound significantly reversed the mechanical
    hyperalgesia in both acute and chronic dosing

GRC 10693 Highly Specific for CB2 over CB1
High Activity Levels in CB2 target
Thomson Database
27
GRC 10693 Clinical Development Update
Clinical Development
  • Glenmark is currently conducting a Phase I
    clinical study in healthy volunteers in Europe.
    This study is designed to investigate the safety,
    tolerability and pharmacokinetics of single and
    multiple doses of GRC 10693.
  • The study will be conducted in approximately 80
    subjects (6 cohorts of 8 subjects each in single
    ascending doses and 4 cohorts on 8 subjects each
    in multiple ascending doses).
  • As of 4th Nov, 2008, the first 4 cohorts of 8
    healthy volunteers each (total of 32), have
    received single doses ranging from 1mg to 90mg.
    All of these doses have been well tolerated with
    no significant cardiac effects (e.g. on heart
    rate, or ECG abnormalities including QTc
    interval) or CNS effects

28
Program GBR 500 - Monoclonal Antibody mAb
  • Strengths of the program-
  • Novel mechanism with very broad anti-inflammatory
    potential
  • First-in-class opportunity no other mAb against
    same target
  • Potential to expand indications to oncology -
    First Xenograft data provides results comparable
    to gold-standard antibodies

29
GBR 500 Broad Anti-inflammatory Potential
  • Broad Anti-inflammatory Potential-
  • Integrins regulate movement of leukocytes and
    cytokine release
  • Alpha2Beta1 integrin antagonist (GBR 500) targets
    integrin receptors and is an effective therapy
    for various inflammatory disorders
  • These disease modifier agents target initiation
    of disease

GBR 500
30
Program GRC 15300
31
GRC 15300 Strengths of the Program
  • Strengths of the program-
  • Glenmark has one of the most in-depth research
    programs in TRP channels globally
  • Potential first-in-class for TRPV3
  • TRPV3 target acts in different temperature range
    devoid of hyperthermia issues. This is contrary
    to some of the TRPV1 antagonists, currently in
    development, which may cause elevated body
    temperatures on inhibition
  • Highly efficacious as compared to current Gold
    standard molecules (Pregabalin, Gabapentin), as
    seen in animal models
  • Non-habit forming class , better option for
    chronic pain therapy

32
GRC 15300 first-in-class opportunity in various
pain conditions
First-in-class Opportunity Some TRPV3 Ligands
Patented But None in Clinical Development
High Efficacy observed in Animal Models of
Neuropathic Pain
33
Program GBR 600 - Monoclonal Antibody mAb
  • Strengths of the program-
  • Novel anti-thrombosis monoclonal antibody
  • High efficacy demonstrated by high potency as
    shown in in vivo primate model large
    therapeutic window
  • Very low/ negligible bleeding liability that is a
    common short-coming of molecules in this class

34
GBR 600 Potentially high efficacy safety
Blood Loss Liability minimised with GBR 600 in
non-human primate model
  • Efficacy Safety of GBR 600
  • Bleeding was self limiting and not severe
  • GBR 600 shows high potency and insignificant
    bleeding in rodent and non-human primate models.

Estimated Global Sales 2007 Plavix USD 16
Bn ReoPro USD 540 Mn Medtrack/ Co. Annual
Reports
(ReoPro)
(Plavix)
Legend Comparison of relative blood loss volume
at 2 x effective dose compared to treatment with
vehicle
35
Program GRC 9332
36
GPL Specialty Business
37
Rest Of The World (RoW) The Year Till Date
Russia CIS Building on stronghold in Russia
while increasing focus on 3 major CIS countries
LatAm -Continuing intense activity in the sphere
of new market entry
India Sharpening focus through divisional
approach
Africa-ME Making inroads into Middle East
markets while driving growth through brands in
Africa
Asia Pacific Rapid growth in invest countries
while building base in new entry markets
38
India Formulations The year till date going
forward
  • Revenue increase of 16.8 over H1 FY 2008
  • Steady growth driven by new brand introductions
    and successful strategy of divisionalisation
  • According to ORG Sep 2008, Glenmark registered a
    value growth of 17.7 in the Indian pharma
    market while market grew at 11.1
  • Launched 15 new products in H1.
  • Major launches include Onabet (Sertaconazole
    first time launch), Deriva CMS (Adapalene
    Clindamycin using microsphere technology), Hair4U
    (Aminexil Minoxidil first time launch)
  • Telma (Telmisartan) entered the top 300 brands of
    the industry

H1 Highlights
  • On track to meet/ beat guidance of 13 growth in
    revenues in FY09
  • Launch gt 20 new products overall in FY2009
  • Maintain leadership in dermatology and
    consolidate position in other therapies

Going Forward FY09
39
India Formulations Revenues and Growth Drivers
  • India Growth Drivers
  • FY09- Increasing share of Dermatology market
    through multiple divisions
  • Innovative product launches (Novel combinations,
    NDDS)
  • Critical Care segment entry through new division
    Critica
  • FY10- Dermatology, Cardiology Diabetology
    segments will fuel the growth
  • Niche product launches in Oncology division
    Onkos
  • Significant value addition from Critica

Revenues in USD Mn
Projected
40
Russia-CIS, Africa-Middle East Asia-Pacific
(Semi Regulated Markets) The year till date
going forward
  • H1 revenues from Asia, Africa and CIS region
    were USD 25.72 Mn registering growth of 10.8
    over H1 2008
  • The company filed 17 products and received 84
    product approvals in SRM region
  • RussiaCIS - Russian market saw launches of 4
    dermatological products in the acne and
    anti-inflammatory therapeutic area
  • Glenmarks Nasik plant successfully
    passed a GMP audit of the Ukraine Ministry of
    Health
  • Africa-ME Operations initiated in Egypt and UAE
  • Amongst important launches were Oncology range
    in Kenya, several new launches in Nigeria
    Mauritius
  • Asia-Pac Strong growth numbers from subsidiaries
    in Malaysia Philippines
  • Entry into hospital segment in Vietnam and
    Malaysia

H1 Highlights
  • The company is on track to achieve growth of over
    20 in Asia, over 35 in Africa and over 70 in
    Russia-CIS region in FY09
  • Operations will be strengthened , teams
    established and product strategies firmed in new
    markets such as China, Australia, Thailand,
    Egypt, UAE and CIS countries
  • Company will actively pursue brand acquisitions
    in invest markets

Going Forward FY09
40
41
Asia-Pacific , Africa-Middle East
Russia-CIS(Semi Regulated Markets) Revenues and
Growth Drivers
Revenues in USD Mn
  • Asia Pacific Growth Drivers
  • FY09- Healthy growth numbers from subsidiaries
    in Malaysia, Philippines
  • Entry into large hospital segments in mkts.
    Including Vietnam, Malaysia
  • FY10- Inorganic growth plans in Thailand,
    Australia China

  • Africa-ME Growth Drivers
  • FY09- New product range launches in Nigeria
  • Onco range launch in Kenya
  • rest organic growth
  • FY10- Inorganic growth in Egypt
  • New product growth in Nigeria
  • Russia CIS Growth Drivers
  • FY09- Growth from existing brands Ascoril line
    extensions
  • Derma portfolio launches
  • FY10- High growth from CIS mkts.
  • High returns on Derma portfolio
  • in-licensed products

USD 15-25 Mn sales are expected to come from
inorganic growth
41
42
Latin America - The year till date going
forward
  • Glenmarks revenues from Latin American
    operations registered an overall decline of 9.4
    over H1 2008. Mainly attributed to tender orders
    that were executed in 1st qtr of last financial
    year.
  • As reported by IMS Sept. 08 , the Brazilian
    subsidiary has shown excellent growth in market
    of 90 over H1 2008
  • IMS Rankings in focus segments have gone up
    rapidly Dermatology 50th in sept.07 to 21st
    in sept. 08 Endocrinology 85th in sept.07 to
    22nd in sept.08
  • Overall 21 products were filed and 13 product
    approvals received in H1 2009
  • Amongst several launches , the company has added
    Quality-of-Life products like Radiaplex
    Oramedic (AloeVera oral rinse) to its oncology
    portfolio
  • Company initiated operations in Mexico

H1 Highlights
  • Operations will be strengthened , teams
    established and product strategies firmed in new
    markets such as Mexico, Venezuela Peru
  • On course to meeting guidance of USD 60 Mn in
    FY09

Going Forward FY09
42
42
43
Latin America - Revenues and Growth Drivers
Revenues in USD Mn
  • LatAm
  • FY09- Organic growth in Brazil and initial
    contribution from Peru, Venezuela
  • FY10- Niche product launches in Brazil New
    Market growth in Peru, Venezuela Mexico

Projected
43
43
44
The year till date and going forward European
Union (EU) -
United States (US)
  • Glenmarks EU operations registered growth of
    160.3 over H1 2008 (mainly attributed to brand
    acquisitions in Poland)
  • Established new company in Poland and acquired a
    portfolio of 7 branded products from Actavis
  • Established subsidiary in Romania, recruited
    sales team and subsequently launched Aflen
    (Triflusal) in the cardiovascular space
  • Glenmark manufacturing site in Czech Republic
    being developed as EU centre for packaging and
    distribution and 1st own product Topiramate
    released for launch across EU

H1 Highlights
  • Glenmark is actively looking at inorganic entry
    options into the US Specialty market
  • The company is evaluating targets with
    proprietary brands and a primary care sales force
  • Central Eastern European regions will be major
    growth driver
  • Focus will be on building infrastructure and
    front ends in new markets such as Romania, Poland
    Bulgaria
  • Company plans to launch atleast 5 products in EU
    in FY2009
  • GPEL (Glenmark Pharmaceuticals Europe Ltd.) will
    shift to Prague in near future

Going Forward
Revenues in USD Mn
Projected
44
44
44
45
GPL Operations H1 Highlights
  • Completed capacity expansion at formulations
    plant at Nashik ,India
  • Commenced site activities at
  • Biologics API plant at Aurangabad, India
  • New formulation plant at Brazil
  • Acquired land from SEZ at Indore, India Basic
    engineering for building over ten lines across
    five dosage forms underway
  • Initiated design of
  • New NCE API plant
  • Capacity expansion at Baddi, India
  • Capacity expansion at Czech plant
  • Functional upgrade in SAP across all India sites
    initiated roll-out of SAP to Latin American
    operations

H1 Highlights
46
GPL Operations Near Future Expansion Plans
47
GPL - Financials Projections
Projected
Gr. 25
Profits In mn
93
123
157
48
GGL Span of Operations
GGL
49
GGL Rapid progression towards attaining its
vision of becoming a Global Integrated Generic
API Leader
  • Active Pharmaceutical Ingredients
  • Continued expansion of API capabilities to
    support both internal and 3rd party dosage forms
  • Focus on difficult to develop molecules
  • Continued filings of DMFs across geographies
  • European Union
  • In process of establishing distribution
    front-ends in Western Europe
  • Licensing distribution partnerships continue to
    be expanded
  • Focus on steady mix of unique niche EU Dossiers
  • North America/ US
  • Rapidly increasing product portfolio market
    share
  • Focus on niche difficult categories
  • Thrust on vertical integration for most products
  • Expanding our strong relationship with the trade
    (chains/wholesalers/distributors)
  • Oncology
  • Glenmark Argentina to continue as the hub of the
    global oncology business
  • Currently expanding presence across LatAm RoW
    markets
  • Focus on developing portfolio for regulated
    markets initiate filings in regulated markets

50
US Formulations The year till date and going
forward
  • Continued excellent performance by Glenmark
    Generics Inc. USA. The subsidiary posted H1
    revenues of over USD 85.90 Mn registering a
    growth of 124.2 over H12008
  • Filed 10 ANDAs with the US FDA and received 5
    approvals during H1 2009. GGI currently has over
    40 ANDAs in various stages of approval with the
    US FDA
  • Among the four first- to-file PIV applications
    submitted, currently in litigation on two of the
    products
  • 5 product launches - Nystatin Oral Suspension,
    Oxycodone Oral Solution, Metformin HCl Tablets,
    Mometasone Cream Mometasone Lotion
  • Portfolio of over 35 generic products, currently
    on the US market ,mix of oral solids/oral
    liquids/semisolids, focused on niche categories
    of controlled substances, modified release and
    dermatology

H1 Highlights
  • Company is on course to launch at least 20
    products in this financial year and complete
    filings of over 30 ANDAs
  • Maintain focus on niche categories and continue
    to evaluate entry into 1-2 new niche categories
    in FY09
  • Manage product portfolio to include a judicious
    mix of PI, PII, PIII and PIV filings

Going Forward- FY09
Revenues in USD Mn
Projected
50
50
50
51
GGL Expanding Presence in the US Generics
Market
Plans to participate in gt 50 of market ,in focus
therapy areas, by 2014
IMS Database MAT June 2008
52
GGL Stepping-up ANDA filings in focus therapy
areas
ANDA Filings Update
FTF ANDA Ongoing Litigation
53
EU Formulations - The year till date and going
forward
  • Glenmark Generics Europe Ltd (GGEL)  achieved a
    major milestone by launching its first product in
    Western Europe via initiation of sales of
    Perindopril tablets in the UK.
  • Filed 8 Marketing Authorization Applications
    (MAAs) till date and has received  approvals for
    2 Glenmark products in several EU markets in H1
    FY09.  
  • Regulatory submission slots were procured with
    various EU regulatory agencies to facilitate a
    further 8 filings in this financial year
  • Culmination of several licensing and supply deals
    with European generic companies high interest
    from both pan European and local European
    partners to participate in our unique portfolio
  • Plans initiated to establish Glenmarks own
    presence in selected key markets

H1 Highlights
  • Western Europe region to be the main growth
    driver
  • Product launches planned in more European markets
    in H2 FY2009
  • On track to make eight product submissions via
    the DCP / MRP / Centralized routes in H2 FY2009
  • Continuing focus on a differentiated product
    portfolio - 2 submissions out of the 8 planned
    are for Dermatology products.  
  • On course to conclude several more out-licensing
    and supply agreements with European generic
    companies.   
  • Continue build out of a finished dosage pipeline
    with backward integration into APIs

Going Forward FY09
Revenues in USD Mn
Projected
53
53
53
54
Oncology (Argentina)- The year till date and
going forward
  • Oncology business posted growth of over 35.9
    with revenues of USD 5 Mn, as against H1 2008
  • Glenmark Generics SA filed 4 dossiers 31 Extra
    company dossiers
  • Launched products in Ecuador, Venezuela, Yemen,
    Paraguay

H1 Highlights
Extra-company excludes Brazil, Trinidad
Tobago, ROW and any other intra-company
operations
  • On track to achieve FY2009 target of 5 filings
    and 8 approvals in Argentina and 64 filings and
    50 launches (extra company)
  • Continue to file dossiers and expand presence in
    other Latin American and ROW markets
  • Develop product portfolio for regulated markets
    and initiate oncology filings in regulated
    markets
  • On course to start the filing of products into
    the regulated market in late FY09/early FY10

Going Forward
Revenues in USD Mn
Projected
54
54
54
55
Active Pharmaceutical Ingredients (API)
The year till date and going ahead
  • Global API business posted growth of over 14.5
    with revenues of USD 22 Mn, compared to H1 2008
  • Initiated business in South Africa Egypt
  • Company has filed 32 DMFs till date. Additionally
    4 European DMFs filed in H1
  • Successful completion of USFDA audit for
    Ankleshwar API facility, India
  • 5 Products DMF process validation batches
    completed

H1 Highlights
  • Continue efforts to become the preferred 3rd
    party API supplier to the generic industry and
    support high value First to File opportunities.
  • Continue to support finished dosage pipeline with
    backward integration into APIs including our
    niche segments
  • On course to file atleast 10 DMFs in current
    financial year
  • Targets entry into new markets in Africa region
  • Focused on development of over 15 APIs annually
    to provide cost and timing advantage to
    complement US and Europe generic filings

Going Forward FY09
Revenues in USD Mn
Projected
55
55
55
56
GGL Operations H1 Highlights
Goa plant (India) increased capacity by 33 .
Added 4th oral solids line ANVISA audit and
approval in Goa Formulations Facility,
India Successful US FDA audit Goa
Formulations Facility, India Successful US FDA
audit - Ankleshwar API facility,
India Successful US FDA audit Mahape
Bio-Analytical facility, India Expansion at
Ankleshwar API plant -Plant 9 operational with  
3KL reaction capacity.
H1 Highlights
56
56
56
57
GGL Operations Near Future Expansion Plans
58
GGL - Financials Projections
429
297
10
196
4
Gr. 44
Gr. 52
Profits In mn
64
87
125
59
Glenmark Consolidated Financials
932
Projected
Revenues In USD Mn
673
499
Gr. 38
Gr. 35
In USD Mn
Basic EPS Doesnt consider impact of dilution
on account of ESOps and convertible bonds In
mn (Assumed exchange rate of 40.28 INR/USD P/E
based on Share Price of Rs. 303 as on 6th Nov 08
60
  • Thank you

For queries on Glenmark Pharmaceuticals
Ltd, please contact media_at_glenmarkpharma.com For
queries on Glenmark Generics Ltd, please
contact connect_at_glenmark-generics.com
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