Canadian approval for Aurobindo’s generic topiramate (Topamax) pills

Aurobindo Pharma, a leading APIs and generic formulations maker from India, has received Canadian approval for the company’s generic topiramate pills.

Health Canada, the Canadian drug regulator, has given approvals for Aurobindo’s Abbreviated New Drug Submission for topiramate tablets 25mg, 50mg, 100mg & 200mg strengths.

Topiramate pills are the generic equivalent of Janssen-Ortho Inc, Canada’s Topamax tablets.

Topiramate pills are indicated as adjunctive therapy for patients with partial onset seizures or primary generalized tonic-clonic seizures and falls under the Central Nervous System (CNS) therapeutic category.

This is Aurobindo’s 9th product approval from Health Canada.

Recently, Aurobindo Pharmasecured marketing approval for cefuroxime antibiotic pills in Canada.

Aurobindo’s cefuroxime axetil tablets are the generic equivalent of GlaxoSmithKline Inc, Canada’s Ceftin.

Cefuroxime antibiotic tablets are indicated for the treatment of a range of mild to moderate infections caused by susceptible strains of the microorganisms.

Headquartered at Hyderabad, India, Aurobindo Pharma Limited manufactures generic pharmaceuticals and active pharmaceutical ingredients.

Aurobindo Pharma ’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.

Aurobindo Pharma’s product portfolio is spread over 6 major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, and anti-allergics.

Aurobindo Pharma has alliances with original research companies in the area of custom synthesis.

Aurobindo Pharma offers a comprehensive custom synthesis services in organic custom synthesis and chemical development. All the six manufacturing plants of the company conform to international standards, with a variety of reactors – more than 300 SS, glass lined, high pressure and sterile reactors, spray drier, and hydrogenators. All are cGMP compliant.

Under the organic custom synthesis module, Aurobindo offers a full range of services to meet the varying needs by utilizing established synthetic routes, modifying customer processes, designing novel routes with complete chemical, chromatographic, spectroscopic back up for starting materials, intermediates, reference compounds, metabolites, resolution of enantiomers, structural isomers etc.

As part of the chemical development service, Aurobindo offers scale-up of existing processes, preparation of intermediates in milligrams to kilo lots, processes optimization, development and use of purification techniques and alternate process routes.

Aurobindo is planning to launch generic lamotrigine pills in the US market soon.

Aurobindo Pharma posted net profit of Rs 128.29 crore in Q2 September 2009 as against a net loss of Rs 38.50 crore in the same quarter last year.

Aurobindo Pharma’s net sales rose 30% to Rs 826.31 crore in Q2 September 2009 over Q2 September 2008.