Aurobindo’s seasonal allergic rhinitis generic cetirizine (Zyrtec) syrup wins US FDA approval

Aurobindo Pharma Ltd, a leading APIs and generics company from India, has 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.

US FDA approval covers 1.0-milliliter dosage of the drug.

Cetirizine syrup is used to relieve symptoms associated with seasonal allergic rhinitis in adults and children above 2 years of age.

Cetirizine approval raises Aurobindo’s total number of abbreviated new drug applications (ANDAs) to 110 which comprise 82 final approvals and 28 tentative ones.

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’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.

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.

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.