- Slides: 10
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 accepted facility, EUGMP Certified and Japan 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 : 236 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 18 products and 5 approved. CEP filed for 9 products and 8 approved. § Validations completed for Quetiapine and Candesartan
Product Range § § § § § Acetazolamide Amiodarone Alendronate Sodium Carbamazepine Carvedilol Chlorothiazide Colesevelam Candesartan Hydrochlorothiazide Irbesartan Lamotrigine Metoprolol Tartrate/Succinate Olmesartan Oxcarbazepine Oxymetazoline/Xylometazoline Pregabalin Quetiapine Sevelamer HCl/Carbonate Terazosin § Terbinafine
Why partner with CTX Lifesciences • Chemistry competence over forty years • Excellent infrastructure viz. water, power, disposal of gaseous, liquid and solid organic wastes and financial strength • c. GMP 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 accepted facility; PMDA accreditation and EUGMP Certified. • Plan to file at least 5 DMFs in 2013 • 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