supporting the global pharmaceutical industry in api/ksm supplies
TRANSCRIPT
Supporting the global pharmaceutical industry In
API/KSM Supplies
OUR VISIONTo evolve into one of the foremost reliable companies in the Pharmaceutical industry, based on our technical capabilities, cGMP commitments and deliveries.
OUR MISSIONTo 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.
• 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
The Company is supported by a well experienced technical staff in Research and Development and Manufacturing.
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).
• 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
We are the “Preferred Approved Source” for many multinational companies (Domestic and International) for their Intermediate / KSM supplies.
Hands on experience in various chemical reactions like Grignard reactions, Dieckmann Reaction, Fischer indole synthesis, Friedel-Crafts Alkylation, Resolutions, Reductions and many more…
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.
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)
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
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
TECHNOLOGY RICH INFRASTRUCTURER&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 API’s and other utilities to cater the existing needs.
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
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 India’s 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
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)
OTHER INTERMEDIATES• Repaglinide intermediate• Valsartan intermediates• Darifenacin intermediates • Vildagliptin intermediates• Sitagliptin intermediates• Tolterodine Tartrate intermediates• Carteolol intermediates
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)
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
For Trade Enquiries, Contact
Shodhana Laboratories LimitedTel: +91-40-66844664 (3 lines)Fax: +91-40-66848998E-mail: [email protected],
[email protected] www.shodhanalabs.net