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CTX LIFESCIENCES PVT LTD CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support building partnersh

CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

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Page 1: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

CTX LIFESCIENCES PVT LTDCTX LIFESCIENCES PVT LTDAn integrated Partner throughout API Cycle

US FDA/EU GMP Certified/PMDA Accreditation and compliant

Chemistry support for building partnerships

Page 2: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

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 green-field facility during second quarter of 2006

Presence in anti-infectives, CVS, CNS, anti-diabetes and other segments

Page 3: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

To be the preferred strategic partner for the pharmaceutical industry and share responsibilities & goals for the enhancement of human health.

Our Vision

Page 4: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

Our Mission

To develop and manufacture Active Pharmaceutical Ingredients and Intermediates for global supply complying to quality and regulatory requirements of our customers.

Page 5: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

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

Page 6: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

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

Page 7: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

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

Page 8: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

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

Page 9: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

Manufacturing and R&D

Page 10: CTX LIFESCIENCES PVT LTD An integrated Partner throughout API Cycle US FDA/EU GMP Certified/PMDA Accreditation and compliant Chemistry support for building

Thank You