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CORPORATE PRESENTATION

CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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Page 1: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

CORPORATE

PRESENTATION

Page 2: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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 1.85% as per AIOCD-AWACS

December 2015

Page 3: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

• Leading positions in select therapeutic areas like Cardiology,

Diabetology, Ophthalmology, Dermatology, Pain / Analgesics

etc.

• PAN India sales presence with a large and over 4500

experienced field force

• State–of–the–art manufacturing facilities approved by USFDA,

UK-MHRA, etc

• 3 R&D centres with capabilities of ANDAs, DMFs and NDDS

About us ….

Page 4: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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 19 divisions each of which is customized to deliver a promotional message to a certain class of specialty customer

• Our 4,500 medical representatives cover over 250,000 doctors & 180,000 pharmacies

Page 5: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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 40 countries, with ground level operations in 15 countries, exporting all major dosages in every therapeutic segment

Page 6: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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

Page 7: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

Manufacturing Facilities

Total No. of Plants: 14

• 3 Sites in Hosur , Tamil Nadu

• 7 Sites in & around Bangalore

• 1 Site in Pondicherry

• 1 Site in Goa

• 1 Site in Baddi

• 1 site in Sikkim

Page 8: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

API Manufacturing facility

Designed to meet EU & US Regulatory Standards, Filed EU DMF

in 2009

Bommasandra, Bangalore – South India

Page 9: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

Facilities

Bommasandra, Bangalore – South India

Sterile eye drops, FFS Pack & 3PCS container, liquid injectable.

Inspected by UKMHRA in November 2010

Page 10: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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.

Page 11: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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)

Page 12: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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).

Hosur, TN, South India

Facilities

Page 13: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for 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).

Page 14: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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.

Facilities

Page 15: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

Facilites Sikkim-East India

Page 16: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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 3 research centers 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.

Page 17: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

R&D brings together ...

Highly Talented

Research Team World Class

Infrastructure

Superior Project

Management

Skills

Well Defined

Processes &

Quality Systems

Page 18: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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

Page 19: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

Formulation Development

Expertise

• Aerosols Dry powders for inhalation and Nasal Sprays

• Ophthalmics Eye drop solution, Suspensions

• Injectables Dry powder and Liquid Injectables

Page 20: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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

Page 21: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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.

Page 22: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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

Page 23: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

• 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.

IPR and Clinical Dept.

Page 24: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

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

Page 25: CORPORATE PRESENTATION - Micro Labs Limited · CORPORATE PRESENTATION . About us ... • State–of–the–art manufacturing facilities approved by USFDA, ... line for bottle (HDPE)

T h a n k y o u