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CORPORATE

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CORPORATE PRESENTATION About us . Established in 1973, Micro Labs is a fully integrated pharmaceutical company, present across the entire pharmaceutical value ... – PowerPoint PPT presentation

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Title: CORPORATE


1
CORPORATE PRESENTATION
2
About us .
  • Established in 1973, Micro Labs is a fully
    integrated pharmaceutical company, present across
    the entire pharmaceutical value chain from
    Research and Development, Active Pharmaceutical
    Ingredients, Finished Formulations to Marketing
    and Distribution in India and overseas.
  • Micro is a privately held company, founded by
    Late Mr. G. C. Surana, now under the leadership
    of Mr. Dilip Surana Mr. Anand Surana
  • Strong Focus in India, with presence in over 30
    countries and 3300 product registrations at
    various stages
  • Ranked amongst top 20 in India with a market
    share of 1.8 as per IMS December 2011

3
About us .
  • Leading positions in select therapeutic areas
    like Cardiology, Diabetology, Ophthalmology,
    Dermatology, Pain / Analgesics etc.
  • PAN India sales presence with a large and over
    3500 experienced field force
  • Stateoftheart manufacturing facilities
    approved by USFDA, UK-MHRA, etc
  • RD centres with capabilities of ANDAs, DMFs and
    NDDS

4
Domestic Operations
  • Pioneer in specialty marketing, with expert teams
    that are built around the specialty customer
  • Contributing significantly to the healthcare
    needs of domestic market for over 3 decades
  • Growing at an annual compounded growth rate of
    14
  • Currently marketing is structured into 14
    divisions each of which is customized to deliver
    a promotional message to a certain class of
    specialty customer
  • Our 3,500 medical representatives cover over
    250,000 doctors 180,000 pharmacies

5
Global footprint
  • Micro is well poised to achieve in the medium
    term status BIG GENERIC COMPANY in the global
    pharmaceutical space
  • Building critical mass in existing markets
    developing business in new market like USA, East
    Europe, North Africa and South Central America
  • The group has presence in over 30 countries, with
    ground level operations in 15 countries,
    exporting all major dosages in every therapeutic
    segment

6
Global footprint
  • Own marketing, regulatory sales operations in
    the following
  • Geographies
  • Asia South East Thailand, Myanmar, Cambodia,
    Vietnam
  • Far East Taiwan, Srilanka, Nepal,
    Philippines, Malaysia,
  • Indonesia, Singapore
  • Middle East Yemen, Iraq, Sudan, UAE
  • Europe CIS Azerbaijan, Russia, Kazakhstan,
    Ukraine, Moldova,
  • Belarus, E.U.
  • Africa South Africa
  • West Africa Senegal, Nigeria, Ivory
    coast, Cameroon
  • East Africa Kenya, Uganda, Tanzania
  • North Africa Algeria, Libya
  • South Central America Mexico, Guatemala,
    Panama, Dominican
  • Republic, Peru

7
Manufacturing Facilities
  • Total No. of Plants 13
  • 3 Sites in Hosur , Tamil Nadu
  • 7 Sites in around Bangalore
  • 1 Site in Pondicherry
  • 1 Site in Goa
  • 1 Site in Baddi

8
API Manufacturing facility
Bommasandra, Bangalore South India
Designed to meet EU US Regulatory Standards,
Filed EU DMF in 2009
9
Facilities
Bommasandra, Bangalore South India
Sterile eye drops, FFS Pack 3PCS container,
liquid injectable. Inspected by UKMHRA in
November 2010
10
Facilities
Bommasandra, Bangalore South India
Cephalosporin Tablets, Capsules, Dry powder
suspension and injectables. The Facilities can
handle packaging in ALU/PVC blister, ALU/ALU
blister, bottle (HDPE) Pouches.
11
Facilities
Hosur, TN, South India
Non pen, non-ceph, Tablets and Capsules
Facilities approved by UK-MHRA, Health Canada and
MCC-South Africa. The Facilities can handle
packaging in ALU/PVC blister, ALU/ALU blister,
bottle (HDPE)
12
Facilities
Hosur, TN, South India
Tablets , Capsules and ointments Facility
approved by Invima Columbia and PAHO (USA) . The
Facilities can handle packaging in ALU/PVC
blister, ALU/ALU blister, bottle (HDPE).
13
Facilities
Veersandra, Bangalore South India
Beta Lactam Tablets, Capsules and Dry powder for
Suspension approved by UK-MHRA, Health Canada
and MCC-South Africa. The Facilities can handle
packaging in ALU/PVC blister, ALU/ALU blister,
bottle (HDPE).
14
Facilities
Goa Western India
Tablets and Capsules Facility(Non-betalactam)
approved by USFDA UK-MHRA. The Facilities can
handle packaging in ALU/PVC blister, ALU/ALU
blister, has an automated packaging line for
bottle (HDPE) packing. Additional Bulk packaging
line would be available after completion of
Expansion.
15
RD Capabilities
  • The company is committed to doing world-class
    research that develops bio-equivalent generics. A
    focused effort in defined areas and a lasting
    interest in new technology are key features of
    our efforts to develop NDDS innovative
    combination products in the medium - long term.
  • Micro RD centre is an integrated set up with 2
    research centres located in Bangalore Mumbai.
  • Analytical facilities range from compound
    identification to bio-analytical capabilities
    consisting of all modern equipments
  • The research team comprises of 300 Scientists /
    Pharmacists / Analysts / Chemists /
    Microbiologists engaged in product analytical
    development.

16
RD brings together ...
17
Formulation Development Expertise
  • Facility is equipped to develop following dosage
    forms
  • Tablets Conventional, Extended Release, Delayed
    Release, Once- a-Day, Chewable, Dispersible,
    Orodispersible and Gastroretentive.
  • Capsules Hard gelatin capsules with Powder,
    Compacts, Pellets and Tablets
  • Liquids Suspensions, Emulsions and Solutions
  • Powders Dry powder for Reconstitution
  • Pellets Uncoated, Film coated and Enteric
    coated pellets
  • Semi-solids Creams, Ointments, Aqueous and
    Hydro-alcoholic Gels

18
Formulation Development Expertise
  • Aerosols Dry powders for inhalation and Nasal
    Sprays
  • Ophthalmics Eye drop solution, Suspensions
  • Injectables Dry powder and Liquid Injectables

19
API RD Capabilities
  • Focus on Development APIs off patent between
    2013-19
  • Strict Compliance IPR / Non-infringing roots.
  • Infrastructure includes facility for scale-up
    validation.
  • Handling complex chemistries.
  • Regulatory complaint development scale-up.
  • File EU-DMF / E-COS / US-DMF
  • 8 Molecules under development

20
Regulatory Affairs
Well trained Regulatory Affairs team in India
for preparing technical dossiers to support
product registration
Our regulatory team is also placed in various
offices globally such as Philippines, Vietnam,
Russia, CIS, UK, Mexico etc. This helps in
better understanding and compliance of local
regulatory requirements in respective region.
21
IPR and Clinical Dept.
  • Dedicated team consisting of Registered Patent
    agents, External consultants with strong
    pharmaceutical expertise help in bringing new
    products (and processes of course) from bench to
    bed site
  • IPR Cell Mandate
  • Infringement Clearance Certificate (ICC)
  • Global Technology Status Watch
  • IP capital generation for the company
  • Capture of Technology in frontier areas
  • RD funding
  • IPR compliant Data Management/Protection
  • Clinical Dept
  • In-house clinical dept to support regulated and
    semi regulated markets

22
IPR and Clinical Dept.
  • Provides inputs on-
  • Review/approval of Bioequivalence protocols
  • Study monitoring to ensure adherence to the
    approved protocol and GCP compliance
  • Bioequivalence reports review
  • Identification/audit of CROs
  • Expert report on BE studies for CTD module-V
  • Clinical and Non-clinical expert reports for
    regulated markets as per CTD format.
  • Co-ordination with RA authorities (for clinical)
    world wide.

23
Future focus
Strategic alliances from..
Out-licensing projects from our development
pipeline Joint product development / Contract
Research with supply of finished products Early
launch through licensing / Royalty / Profit
Share Contract manufacturing in regulated
markets In-licensing products / authorized
generics for global sales
24
T h a n k y o u
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