hikal revenue ($ mn) - pharmacompass · hikal is a flexible, execution focussed customer oriented...
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Company Overview
• Established in 1988
Listed on the Bombay Stock Exchange
• Equity structure
– Principal shareholders (69%)
• Hiremath and Kalyani families
– World Bank, Washington D.C. (IFC) 9%
– Global Institutional Investors - 11%
– Public – > 8000 shareholders
• Investment Grade Credit Rating – Moody’s
• Business Focus:
• Pharmaceuticals
• Crop Protection
• Specialty Chemicals
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40 4152
8089 82
116 110
138 145
0
20
40
60
80
100
120
140
160
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Hikal revenue ($ mn)
© Hikal Limited 2
Locations
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Head Quarters
Chemicals
Pharma
Research & Development
U.S. Presence, New Jersey Japan Office, Tokyo
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Board of Directors
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Baba Kalyani
Jai Hiremath
Chairman & MD
Sameer Hiremath
President & Joint MD
Prakash Mehta Sugandha Hiremath Kannan Unni Dr. Axel Kleemann
Amit Kalyani
Shivkumar Kheny
Dr. Wolfgang Welter
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Leadership Team
Jai Hiremath
Chairman & MD
Sameer Hiremath
President & Joint MD
Kumar Inamdar
Crop Protection
Sham Wahalekar
Finance Anish Swadi
Strategy
Kumaar Priyaranjan
HR
Manoj Mehrotra
Pharmaceuticals
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Global Sales Distribution
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Human Resources – Our Intellectual Capital
Experienced workforce working with global innovator and speciality chemical companies
Employees continuously trained through in-house workshops and external programs
Total workforce – 1,163
Production, 347
Engineering, 135
Quality, 133
R&D, 206
Scale-Up, 107
EHS, 40
Support Functions, 195
PhDs, 23
MSc, 261
Engineers, 134Graduates and
Others, 745
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First Indian Company to become a Member of Rx 360
Been an active Rx 360 member since 2010
Rx 360 Facility Audit Report on file
Hikal - Head of Strategy - Member of the Board of Rx 360 (November 2014)
Formed the India Working group in January 2015 ; Co-Head of the India Working Group
Leading the initiative to educate companies and attract more membership and participants
Working with the trade organizations in India (Supply Chain Security initiatives)
Serve on the “Data Integrity Working Group”
Focusing on the security challenges in the local Supply Chain
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"At Hikal, we are an integral part of the global supply chain for medicines. Protecting the integrity of
this supply chain is our obligation and responsibility.”
Regulatory Approvals
• USFDA : Last inspection in April 2014
5th inspection after September 2012, August 2011, June 2008 & June 2004
• EDQM : June 2014
• WHO : Last inspection in December 2015
• KFDA : February 2011
• TGA : March 2006 (certification extended up to 2015)
• PMDA (Japan) : November 2012
• FSSC 22000 : December 2013
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QA and QC personnel regularly trained to comply with all recent changes
Sites are audited frequently by multinational innovator companies from the US, Europe & Japan
Integrated Management System
ISO 9001 : February 2014
ISO 14001 : February 2014
OHSAS 18001 : February 2014
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Antidepressant
Anticonvulsant Antiemetic
Antihistamine Antipsychotic
Antialzheimers
Antihypertensive
Antilipemic Hemorheologic
Antidiabetic Antithrombotic
Antiviral
Therapeutic Categories – Hikal Product List
Regulatory Filings – DMF & CEP
11
Total 18 USDMF filed in various therapeutic categories
9 CEP to Hikal’s credit USDMF CEP
Gabapentin
Gabapentin Process 2
Ondansetron
Ondansetron HCl
Gemfibrozil
Triprolidine HCl
Venlafaxine HCl
Venlafaxine Base
Bupropion HCl
Bupropion Process 2
Cinnarizine
Memantine HCl
Quetiapine Fumarate
Donepezil HCl
Pregabalin
Pregabalin Process 2
Pentoxifylline
Vildagliptin
Decoquinate
Acebutalol HCl
Lacosamide
Olmesartan Medoxomil
Quetiapine Fumarate
EUGMP
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Intellectual Property – Patent Strength at Hikal
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Total 67 Patents/ Patent Applications
22 Patents are granted in various countries / jurisdictions
Granted Patents - Pharmaceuticals
Gabapentin
Pregabalin
Vildagliptin
Venlafaxine
Ondansetron
Triprolidine
Valproic acid
Memantine
Donepezil
Quetiapine
Halo-dialkoxybenzene
Prasugrel
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API Development Pipeline at Hikal
Apixaban
Dabigatran Etexilate Mesylate
Darunavir Ethanolate
Rivaroxaban
Sitagliptin HCl/Phosphate Monohydrate
Flurbiprofen
Duloxetine
Valacyclovir HCl
Cobicistat
Dapagliflozin
Canagliflozin / Hemihydrate
Butorphanol
We also offer Intermediates of API from our Product List
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Solid State (Particle size)
Polymorph
Intellectual property
Regulatory support
Non-infringing routes, Novel routes
Customer Support
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Manufacturing Plants – Pharmaceuticals
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Commercial Facilities
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• US FDA : September 2012
• EU GMP : January 2014
Panoli – US FDA approved site for manufacturing cGMP Intermediates
Bangalore – US FDA approved site for manufacturing cGMP Intermediates & API’s
• ISO 9001
• ISO 14001
• OHSAS 18001
• USFDA : April 2014, August 2011, June 2004 & June 2008
• EU GMP : January 2014
• WHO GMP
• KFDA
• TGA
• PMDA (Japan)
• ISO 9001
• ISO 14001
• OHSAS 18001
Research & Development Facility - Pune
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3 Pharma manufacturing facilities with potential for expansion
New multi-purpose plant being constructed
• Total reactor volume 205 m3
– Glass lined 46 m3
– Stainless steel 159 m3
• Number of reactors 45
• Reactor size 450 - 10,000 L
• Agitated Nutsche filters 6,500 L
• Rotary vacuum driers 2000 L
• Fluidized bed drier 100 kg/hour
• AHU system for powder processing area
• High capacity bromination facility
• High temperature reaction facility (+2400c)
• High vacuum distillation facility
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Panoli – US FDA Approved site for RSM’s & Advanced Intermediates
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Panoli – US FDA Approved site for RSM’s & Advanced Intermediates
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cGMP multipurpose API facilities
• Inspected and recertified by USFDA 4th time (April 2014)
• OHSAS 18001, ISO 14001
• Responsible Care certified
• 9 API production lines with finishing areas
• PLC controlled plants
• Total reactor volume 294 m3
– Glass lined 119 m3
– Stainless steel 175 m3
• Number of reactors 94
• Solvent recovery plant: 140 m3/day
• Zero discharge waste water treatment facility 450 m3/day
• Employees 347
Bangalore - USFDA Approved site for APIs & Intermediates
External View Multipurpose Plant , Bangalore
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Bangalore - USFDA Approved site for APIs & Intermediates
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Multipurpose and multi-product facility – API’s & Intermediates
• Area : 8,114 m2
• Plant has Two Sections
– Section – 1 , Pilot Plant
• 2 production trains with 6-reactors
• Can make two Products simultaneously
• Total reactor volume ~ 10.85 m3
• Batch size 5 – 60 Kg
– Section – 2 , Scale Up Plant
• Up to 8- reactors
• Total reactor volume ~ 21.8m3
• Batch size 50 - 300 Kg
Bangalore - Scale-Up & Launch Plant
© Hikal Limited
Why we would be a potential partner
Hikal is a flexible, execution focussed customer oriented company
Continued focus on Quality & Regulatory Governance
We utilise technology to address our customer’s challenges
We execute our projects with disciplined processes
We deliver on our commitments
Collaborative approach to working with our partners for mutual benefit
We provide our partners with a distinct sustainable solution and advantage
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