Transcript Corporate presentation

CORPORATE
PRESENTATION
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
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
• State–of–the–art manufacturing facilities approved by USFDA,
UK-MHRA, etc
• R&D centres with capabilities of ANDAs, DMFs and NDDS
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
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
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
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
API Manufacturing facility
Bommasandra, Bangalore – South India
Designed to meet EU & US Regulatory Standards, Filed EU DMF
in 2009
Facilities
Bommasandra, Bangalore – South India
Sterile eye drops, FFS Pack & 3PCS container, liquid injectable.
Inspected by UKMHRA in November 2010
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.
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)
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).
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).
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.
R&D 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 R&D 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.
R&D brings together ...
Highly Talented
Research Team
Superior Project
Management
Skills
World Class
Infrastructure
Well Defined
Processes &
Quality Systems
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
Formulation Development
Expertise
•
Aerosols
Dry powders for inhalation and Nasal Sprays
•
Ophthalmics
Eye drop solution, Suspensions
•
Injectables
Dry powder and Liquid Injectables
API R&D Capabilities
• Focus on Development API’s 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
Regulatory Affairs
Well trained Regulatory Affairs team in India for preparing technical
dossiers to support product registration
RA
SEMI REGULATED MARKETS
REGULATED MARKETS
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.
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
R&D funding
IPR compliant Data Management/Protection
•
Clinical Dept
•
In-house clinical dept to support regulated and semi regulated markets
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 CRO’s
•
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.
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
Thank
you