Api manufacturers, Pregabalin, Glyburide, Glibenclamide Bp

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Glibenclamide Bp,Glibenclamide Ep,Nalidixic Acid Bp,Nalidixic Acid IpPregabalin,Api manufacturers,Glibenclamide Ip Gujarat,Glibenclamide Bp Gujarat,Nalidixic Acid Ep-Elixir Pharma,Ahmedabad,Gujarat,India

Emerge as a leading Fine Chemicals, Intermediates, APIs & Chemistry Services provider

Elixir Pharma is founded in Sep 2009 by a group of seasoned, experienced techno commercial professionals in Ahmadabad, Gujarat (India). Elixir Pharma aspires to emerge as a leading Fine Chemicals, Intermediates, APIs & Chemistry Services provider to Global Life Science Companies so as to enable them in bringing innovative products to markets in the most effective & efficient manner in terms of cost, quality & time. With experienced team of scientists & engineers; GLP compliant labs and WHO GMP manufacturing plants in Ahmadabad, Elixir Pharma is suitably placed to quickly supply quality products APIs and Intermediates across the scale and solve our clients’ challenging development, scale-up & regulatory needs by offering a broad range of development services.

Vision :

To be among top 100 Pharmaceutical Company in India by 2020 with sales revenue of more than INR 100 Cr (USD 20 Mn)

PRODUCTS 

APIs

•  Antibacterial/UTI Infection

o   Nalidixic Acid IP/BP/EP/USP (DMF Available in CTD Format, CEP Submitted)

•   Anti Diabetic

o   Glibenclamide IP/BP/EP (DMF Available in CTD Format, CEP Submitted)

o   Glyburide USP (USDMF Under Preparation)

• Neuropathic Pain (CNS)

•   Pregabalin IP/IH

 INTERMEDIATES

• L-Valine Methyl Ester HCl - Valsartan Intermediate
• 3-Isobutylglutaric acid, [CAS No: 75143-89-4] CMH Diacid - Pregabalin Intermediate
• 5-Chloro-2-methoxy-n-[2-(4 sulfamoylphenyl) Ethyl] benzamide - Glibenclamide/Glyburide Intermediate
• Dibenzo-[b,f]1,4] thiazepin-11(10H)-one CAS No. 3159-07-7 for Quetiapine
• (3-Cabamoylmethyl)-5-Methylhexanoic Acid [CAS No:181289-52-7] for Pregabalin
• 2-(chloromethyl)-4-methylquinazoline having CAS No: 109113-72-6 for Linagliptin

 CHEMISTRY SERVICES

Custom Synthesis of Intermediates, APIs & NCEs

• cGMP/Basic GMP Manufacturing of Intermedi ates, APIs & Release
• Process Development, Synthetic Route Selec tion & Optimization
• Process scale-up and validation
• Technology Adaptation & Cost Reduction
• Analytical Method Development & Valtion
• Stability Studies as per ICH
• Regulatory Support for CMC/DMF

 QUALITY & REGULATORY

QA/QC

• Experienced and adequately staffed QA/QC Department  
• HPLCs, GC with Head Space, UV Spectrophotometer; Polarimeter; Melting Point Apparatus; Analytical Balance
• Designated chemical storage area for standard chemicals
• Designated sample room, wash area & glass ware storage area
• Designated wet lab with Sonicator, pH Meter; Conductivity Meter; Water Bath; KF automatic titrators ; 
• Well equipped Microbiology Testing Lab

QUALITY AND EHS&S SYSTEM

• ICH Q7A Compliant Operations 
• WHO GMP Approved Manufacturing Facility 
• ISO 9001:2000, ISO 14001 & OSHA Certified Facility 
• Well Defined Quality & EHS Policies in place which are endorsed by Top Management 
• Site surveillance with CCTV Cameras

For more detail Visit us at : http://www.elixirpharma.in