intas group 4 clinical research & pharmacovigilance 10
TRANSCRIPT
Generics are in our DNA
Intas Group 4
Intas 3P Global Set Up 5
Our History 6
R & D 7
Manufacturing Capabilities 8
Quality 10
Clinical Research & Pharmacovigilance 10
Future novel technology development 11
Generics are in our DNA
Intas GroupLeading Global Pharmaceutical company.
Headquartered in Ahmedabad, India.
Vertically integrated: API Formulation Development Manufacturing Licensing Supply.
10 manufacturing sites, in India, Mexico and UK.
Global strategy including alliances with wide platform of pharma companies.
Global sales of USD 700 million.
50% sales to regulated international markets.
MELBOURNE
BARCELONA
SÃO PAULO
MONTREALLONDON
Intas 3P Global Set UpAhmedabad, India R&D and Manufacturing.
Barcelona, Spain Worldwide Management, BD&L for EMEA, IP, A/W, Compliance Management, Supply Chain, Legal and EU Testing & Release labs.
London, UK Regulatory, EU Testing and Release labs., Primary & Secondary Packaging and Warehousing.
Melbourne, AustraliaBD&L for APAC.
Montreal, CanadaBD&L for Canada.
São Paulo, BrazilBD&L for LATAM.
AHMEDABAD
Generics are in our DNA
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R&D02
Intas R&D team provides development services to pharma companies across the world.
Over 400 research scientists for non-clinical product research.
New EU testing & release facilities in Barcelona to provide complete QP services for EU markets.
Generics are in our DNA
Our History
1976 Founded by Shri Hasmukh K. Chudgar.
1999 Clinical Research affiliate foundation.
1996 Matoda GMP facility completed.
2000 Biotech affiliate foundation.
2001 Contract Research affiliate foundation.
2003 Cytotoxic facility commissioned at Matoda.
2006 FDA approval of Matoda manufacturing site.
2007 New cytotoxic API plant commissioned.
2010 Start production at new manufacturing site - SEZ.
2011 Entered Top 10 ranking in India.
2013 First Indian origin biosimilar approved in EU (G-CSF).
2014 Global first Nanosomal Docetaxel launch. New EU testing & release facilities in Barcelona, Spain.
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Pharmaceutical form
Solid orals
Tablets 10,200 millionCapsules 940 millionEffervescent tablets 300 millionPellets 30,000 kg
Anti-cancer
Tablets and capsules 600 millionLiquid vials 15 millionLyo vials 4.3 millionPFS 1.5 millionOintments 24,000 Kg
Standard IV products
Liquid vials 30 millionLyo vials 3 millionLiquid ampoules 85 millionPFS 7 million
Manufacturing Capabilities03
SEZ site in operation since 2010.
Matoda site in operation since 1996.
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Generics are in our DNA
SEZ. Manufacturing Site. Ahmedabad, Gujarat, India.
Matoda. Manufacturing & API Site. Ahmedabad, Gujarat, India.
Own production of APIs (high potency & standard APIs).
Capacity / year
Quality
Clinical Research & PV
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Future novel technology development06
Full cGMP approvals from prominent international regulatory bodies:
BUREAU VERITASCertification
US (FDA), Europe (EMA), Australia (TGA), UK (MHRA), Brazil (ANVISA), South Africa (MCC), Turkey (T.C. Sağlık Bakanlığı) and Gulf (GCC), ANMAT (Argentina)
Environmental concerned company:
• ISO 14001:2004 Hazard Identification.• OHSAS 18001:2007 Risk Assessment and Control.
Intas’ biotech affiliate is front-runner in the Indian biopharmaceutical sector. First Indian origin biosimilar approved in EU (G-CSF).
Fully integrated R&D and manufacturing capabilities. Microbial & mammalian cell platforms.
cGMP approved by EU authorities and full R&D services.
Launched in India:
G-CSF
Peg-G-CSF
Interferon α-2b
Peg-Interferon α-2b
EPO-α
Rituximab
PTH
FSH
Pipeline of 12 new biosimilars including mAbs.
Cutting edge nanosomal technology.
Global first Nanosomal Docetaxel approved by Indian Regulatory Agency.
Lipid platform to be applied to other molecules.
Dossiers approved worldwide in EU, USA, Canada, Australia, Latin America, etc.
Strong focus on oncology and CNS areas.
Product portfolio of 100+ products.
Platform of customers on a global basis.
Intas is one of the largest Indian pharmaceutical organizations with presence across the globe.
Growth lies with the choice of partners...
Biosimilars New Drug Delivery Systems
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Intas’ Clinical Research Organization (CRO) is one of the biggest in India.
Centers in North America and Europe -> Global clinical research across 3 continents.
550 clinical research employees.
Performed about 5,000 clinical trials: Phase I – IV and BE studies.
More than 500 submissions in North America, Europe and Australia.
Pharmacovigilance services to meet EU PV obligations.
Head OfficeChinubhai Centre, Ashram Road,Ahmedabad - 380009, Gujarat - IndiaPhone: +91 79 265 766 55 - Fax: +91 79 265 788 62
www.intaspharma.com
Global Licensing & Third Party Sales OfficeWorld Trade Center, Edifici Est, 6 plantaMoll de Barcelona s\n, 08039 Barcelona - SpainPhone: +34 93 301 73 51 - Fax: + 34 93 318 38 03
Intas Pharmaceuticals Ltd.
EU/IN
T/01
6/09
/13
Generics are in our DNA
Generics are in our DNA