Transcript Slide 1 - CTX Lifescience Pvt Ltd

Chemistry support for
building partnerships
CTX LIFESCIENCES PVT LTD
An integrated Partner throughout API Cycle
US FDA/EU GMP Certified/PMDA Accreditation
and compliant
Who we are
 Colourtex, a 40-year old largest dyes and intermediates
company in India with over 2000 employees and annual
revenues of USD 250 millions, diversified into
Pharmaceuticals in 2004
 Privately held Company headquartered in Surat, 260 kms
north of Mumbai. Surat - a major hub for Chemicals and
Diamonds
 Commercial production started in the state-of-the-art greenfield facility during second quarter of 2006
 Presence in anti-infectives, CVS, CNS, anti-diabetes and
other segments
Our Vision
To be the preferred strategic partner for the
pharmaceutical industry and share responsibilities &
goals for the enhancement of human health.
Our Mission
To develop and manufacture Active
Pharmaceutical Ingredients and Intermediates
for global supply complying to quality and
regulatory requirements of our customers.
Our Mfg Strengths and Plans
 US FDA inspected and compliant facility, EUGMP
Certified andJapan Accredited with over 200,000 sq.ft
area spread on 38 acres of land. One facility for all
markets. Large intermediate plant.
 Cost effective operating structure with vertical integration
in some products
 Skilled workforce and competent technical & management
team with global and global pharma experience
 Total number of reactors : 83 Nos.
 Total reactors volume : 220 meter cube
 Total number of people : 296
Our Mfg Strengths and Plans
 Access to own large infrastructure, viz. water reservoirs,
power generation, effluent treatment plant, landfill site and
incinerators. Also, large intermediate plant
 Can handle complex chemical reactions viz., cynation,
nitration, chlorosulfonation, hydrogenation and ethoxylation
 Investment over USD 27 millions
 US DMF filed for 17 products and four approved. CEP filed
for 9 products and seven approved.
 Validations completed for Pregabalin and Quetiapine and
under validation for Candesartan
Product Range



















Amiodarone
Alendronate Sodium
Acetazolamide
Carvedilol
Chlorothiazide
Carbamazepine
Hydrochlorothiazide
Irbesartan
Lamotrigine
Metoprolol Tartrate/Succinate
Olmesartan
Oxcarbazepine
Oxymetazoline/Xylometazoline
Pregabalin
Terbinafine
Terazosin
Sevelamer Hcl
Colesevelam
Candesartan
Why partner with CTX Lifesciences
•
Chemistry competence over thirty years
•
Excellent infrastructure viz. water, power, disposal of gaseous, liquid and solid organic
wastes and financial strength
•
cGMP compliant state of the art facility with focus on API and Intermediates. Facility
audited by Astra Zeneca, Glaxo, Novartis, EMerck, Aventis,, Teva, Mylan, Sandoz,
Actavis, Siegfried, Pliva and visit by Pfizer and found to comply their requirements.
•
US FDA inspected and compliant facility; PMDA accreditation and EUGMP Certified.
•
Plan to file at least 5 DMFs in 2012
•
Experienced technical and commercial team with global and global pharma
experience.
•
Vertical integration on Hydrochlorothiazide, Xylometazoline, Oxymetazoline, Irbesartan
Sevelamer, Colesevalam, and Lamotrigine and working on Metoprolol Tartrate,
Succinate and Oxcarbazepine
•
Environment, Safety and Health Practices
Manufacturing and R&D
Thank You