CORPORATE PRESENTATION

Transcription

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 1.85% as per AIOCD-AWACS December 2015

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 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

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 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

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 40 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: 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

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 Facilites Sikkim-East India

16 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.

17 R&D brings together... Highly Talented Research Team World Class Infrastructure Superior Project Management Skills Well Defined Processes & Quality Systems

18 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

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

20 API R&D Capabilities Focus on Development API s off patent between 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

21 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.

22 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

23 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 IPR and Clinical Dept. 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.

24 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

25 T h a n k y o u