Aurobindo’s generic cefotaxime (Claforan) injectables get US FDA approval

Aurobindo Pharma has got the final approval from the US FDA to market its generic version of antibiotic cefotaxime injection used for treating various infections.

Aurobindo’s cefotaxime is the generic version of global drug major Sanofi Aventis’ Claforan injection.

Aurobindo has received final approvals from the US Food & Drug Administration (USFDA) for two abbreviated new drug applications (ANDAs)–cefotaxime for Injection in the strength of 1g, 2g and cefotaxime for injection in 10g (pharmacy bulk pack) dose, Aurobindo Pharma said in a statement to the Bombay Stock Exchange.

Cefotaxime falls under the anti-betallactum segment.

Cefotaxime is indicated for the treatment of patients with lower respiratory tract infections, genitourinary infections, gynecologic infections, bacteremia/septicemia, skin and skin structure infections, intra-abdominal infections, bone and/or joint infections caused by Staphylococcus aureus (penicillinase and non-penicillinase producing strains), and central nervous system infections.

Aurobindo plans to launch cefotaxime injectable products immediately in the US market.

Mumbai-based Wockhart and Orchid Pharma from Chennai are among the other indian companies secured approval for cefotaxime injection in the US market way back in 2006.

With cefotaxime injectables, Aurobindo Pharma now has total 109 ANDA approvals, which includes both tentative and final, from the USFDA.

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.

During the quarter ended September 2009, the company incurred a foreign exchange loss of Rs 3.70 crore.

Aurobindo Pharma Ltd’s gross margin improved to 52.2% from 49.1% last year and operating profit before Fx improves to 23.5% in comparison with 17.6% last year.

Aurobindo Pharma’s operating profit (EBIDTA) before Fx up 65.7% to Rs 207.0 crores from last year’s 124.9 crore. PBT before Fx up by 95.5% to Rs 164.6 crores against Rs 84.2 crores.

Aurbindo Pharma’s PAT before Fx up by 60.1% to Rs 106.8 crores against Rs 66.7 crores.

Aurobindo’s formulation sales went up by 39.4% to Rs 445.2 crores against Rs 319.3 crores a year ago. Formulations sales constitute 51.3% against 44.1% of gross sales.
Shares of Aurobindo Pharma today closed at Rs 819.30, up 0.33 per cent from its previous close on the Bombay Stock Exchange.