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Aurobindo’s generic ondansetron (Zofran) pills gets US approval

Wednesday, April 14, 2010, 19:52 This news item was posted in Industry category and has 0 Comments so far.

Aurobindo Pharma Limited, a leading APIs an generics player from India, has received the final approval for ondansetron orally disintegrating tablets (ODT) from US FDA.

US FDA has approved Aurobindo’s abbreviated ondansetron pills USP in strengths of 4mg and 8mg, the company announced.

Ondansetron ODT 4mg and 8mg are the generic equivalent Glaxo SmithKline’s Zofran ODT 4mg and 8mg.

Ondansetron ODTs are antiemetics and indicated for prevention of nausea and vomiting in patients undergoing chemotherapy, radiation therapy or surgery.

Ondansetron ODTs products are ready for launch.

Aurobindo now has a total of 115 ANDA approvals (86 final approvals and 29 tentative approvals) from USFDA.

Recently, Aurobindo Pharma Limited has received the final approval for venlafaxine pills in US.

The US Food & Drug Administration (USFDA) has approved Aurobindo’s abbreviated new drug application (ANDA) for venlafaxine hydrochloride tablets in 25mg, 37.5mg, 50mg, 75mg and 100mg strengths, the company announced.

Aurobindo’s venlafaxine hydrochloride pills are the generic equivalent of Wyeth Pharmaceutical’s Effexor tablets.

Venlafaxine pills are indicated for the treatment of major depressive disorder (MDD) and falls under the therapeutic category of CNS (Central Nervous System).

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.

US FDA has granted final approval for generic cetirizine hydrochloride syrup, used for treating allergic rhinitis, Aurobindo Pharma stated in a press release.

In November 2009, Aurobindo Pharma got tentative approval from US FDA to market anti-hypertension drug perindopril erbumine pills.

Aurobindo’s generic perindopril erbumine pills are are the therapeutic equivalents of Solvay Pharmaceuticals’ Aceon tabs.

Perindopril erbumine come under CVS segment and is prescribed for treating patients suffering from high blood pressure.

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.

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