Aurobindo Pharma, a leading APIs and generic formulations maker from India, has secured marketing approval for cefuroxime antibiotic pills in Canada, the company announced.
Health Canada, the Canadian health regulator, has given approval for Aurobindo’s Abbreviated New Drug Submission (ANDA) fro cefuroxime axetil tablets in 250mg & 500mg strengths.
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.
Cefuroxime’s is Aurobindo’s 8th product approval from Health Canada.
Recently, Aurobindo Pharma Limited has received the tentative approval to manufacture and market anti-HIV medicine nevirapine tablets for oral suspension 50mg from the US Food & Drug Administration, the company announced in a press release.
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), marketed under various brand name including Viramune by its innovator Boehringer Ingelheim.
Nevirapine is reportedly the first NNRTI approved by US FDA.
With nevirapine Aurobindo now has a total of 113 ANDA approvals (84 Final approvals and 29 Tentative approvals) from USFDA.
In December last year, Aurobindo Pharma Ltd secured approval for its generic cetirizine hydrochloride syrup from the U.S. Food and Drug Administration.
Aurobindo’s cetirizine hydrochloride syrup is a therapeutically equivalent version of Johnson & Johnson’s unit McNeil Consumer Healthcare’s Zyrtec.
In November, Aurobindo Pharma got tentative approval from US FDA to market anti-hypertension drug perindopril erbumine pills in 2 mg, 4 mg and 8 mg strengths.
Aurobindo Pharma, on Nov 09, also won final authorizations from US FDA for 2 ANDAs including Cefotaxime for jab USP 500 mg, 1g, 2g and Cefotaxime for jab USP 10 g pharmacy bulk pack.
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.