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Supporting the global pharmaceutical industry In API/KSM Supplies.

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Presentation on theme: "Supporting the global pharmaceutical industry In API/KSM Supplies."— Presentation transcript:


2 Supporting the global pharmaceutical industry In API/KSM Supplies

3 OUR VISION To evolve into one of the foremost reliable companies in the Pharmaceutical industry, based on our technical capabilities, cGMP commitments and deliveries. OUR MISSION To support the global pharmaceutical industry in API/KSM supplies, custom synthesis and contract manufacturing. Shodhana wishes to introduce a minimum of two bulk actives, besides intermediates, every year.

4 Shodhana Laboratories based at Hyderabad A.P. India, was established in September 2000 by a technocrat entrepreneur with a Doctorate in Chemistry and 20 years of rich industrial experience in various organizations

5 The Company is supported by a well experienced technical staff in Research and Development and Manufacturing.

6 OUR TECHNICAL STRENGTHS AND CAPABILITIES Good knowledge on cGMP requirements, regulatory requirements, DMF preparations and filing, systems development and implementation. Knowledge on Polymorphism (Preparation of different polymorphs in the lab as well as in manufacturing scale, analysis by powder XRD, DSC & FTIR and their interpretation).

7 Good Scientific knowledge about process development, scale up and commercialization and adaptation of new processes and technologies Capable of Patent evaluation, Implications and Patenting processes

8 We are the Preferred Approved Source for many multinational companies (Domestic and International) for their Intermediate / KSM supplies.

9 Hands on experience in various chemical reactions like Grignard reactions, Dieckmann Reaction, Fischer indole synthesis, Friedel- Crafts Alkylation, Resolutions, Reductions and many more…

10 CUSTOM CHEMICAL SYNTHESIS We have a proven track record for Custom Chemical Synthesis. Successfully fine tuned several rough processes in lab and has capability to develop new /novel /alternate processes.

11 COS / CEP Status Carvedilol - COS / CEP granted (CEP 2008 - 259) Ondansetron Hydrochloride Dihydrate - COS / CEP under review (CEP 2009 - 114) Citalopram Hydrobromide - COS / CEP under review (CEP 2010 - 228)

12 SYSTEMS AND AUDITS Shodhana is an ISO 9001-2008 Certified and WHO GMP certified - holding the status for the past seven years We have been audited by several international customers besides large domestic customers for our adherence to cGMP

13 REACTION VOLUMES AND SUPPORTING SYSTEMS Shodhana and its Subsidiary Units have Stainless Steel and Glass Lined Reaction Vessels, including pressure vessels, of various sizes amounting to about 220KL reaction volume Our facilities have multiple effect evaporators for handling effluents and solvents efficiently

14 TECHNOLOGY RICH INFRASTRUCTURE R&D facilities 200 sq. meters established R&D with all the necessary equipment. Rota Evaporators, Autoclaves, Fume Hoods etc. An additional R&D facility of 400 sq meters is under commissioning. Production We also have sufficient boilers, chilling plants, hot oil circulation systems (for high temperature reactions and distillations), scrubbers, clean rooms for making final APIs and other utilities to cater the existing needs.

15 ANALYTICAL FACILITIES 7 HPLC systems of Waters, Shimadzu and Agilent Gas chromatographs along with head space analyzer FTIR spectrophotometer UV/VIS spectrophotometer Digital polarimeter, auto titraters etc. besides the conventional analytical equipment

16 FUTURE PLANS Acquired 8000 sq. yards, adjacent to our current facility, with constructed buildings for expansion. Acquired 5 acres of land in Jawaharlal Nehru Pharma City near Indias sea port city of Visakhapatnam in Andhra Pradesh at a site that has been developed by the Government especially for Chemical industries, with all the necessary effluent treatment facilities

17 BULK ACTIVES and its Intermediates Carvedilol (CAS No.72956-09-3) Carvedilol Phosphate (CAS No.610309-89-2) Citalopram Hydrobromide (CAS No.59729-32-7) Duloxetine Hydrochloride (CAS No.136434-34-9) Escitalopram Oxalate (CAS No.219861-08-2) Ondansetron Hydrochloride dihydrate (CAS No.103639 - 04 - 9) Ondansetron Base (CAS No. 99614-01-4) Rivastigmine Hydrogen Tartrate (CAS No. 129101-54-8) Ranolazine (CAS No. 95635-55-5) Rosiglitazone Maleate (CAS No. 155141-29-0)

18 OTHER INTERMEDIATES Repaglinide intermediate Valsartan intermediates Darifenacin intermediates Vildagliptin intermediates Sitagliptin intermediates Tolterodine Tartrate intermediates Carteolol intermediates

19 Other products N-Methyl-1-Naphthyl methyl amine hydrochloride (CAS No. 65473-13-4) (for Terbinafine and Butenafine) 2,3;4,5-Bis-O(1-methylethylidene)-β-D-fructopyranose (CAS No. 20880-92-6) (Topiramate intermediate) N-Boc-Prolinamide (CAS No. 35150-07-3) L-Prolinamide (CAS No. 7531-52-4) N-Boc-L-Proline (CAS No. 15761-39-4) 2-Methyl cyclohexane 1,3-dione (CAS No. 1193-55-1) (+)-O,O-Di-p-tolouyl-D-Tartaric acid- ((+)- DPTTA)- (CAS No. 32634-68-7) (-)-O,O-Di-p-tolouyl-L-Tartaric acid- ((-)DPTTA)- (CAS No. 32634-66-5) L-Valinamide HCI (CAS No. 3014-80-0) Diethyl-D-tartrate (CAS No. 13811-71-7) L-Alanine methyl ester HCI (CAS No. 2491-20-5) L-Proline methyl ester HCl (CAS No.2133-40-6)

20 Products under scale up Repaglinide Tolterodine Tartrate Carteolol hydrochloride Levodopa Carbidopa Products under development Mizolastine Topiramate Nebivolol Valsartan Pramipexole Sitagliptin Vildagliptin Darifenacin Dothiepin Racecadotril Lidocaine

21 For Trade Enquiries, Contact Shodhana Laboratories Limited Tel: +91-40-66844664 (3 lines) Fax: +91-40-66848998 E-mail:,

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