Nevirapine oral suspension pills by Aurobindo gets tentative approval in US

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.

The New Drug Application (NDA) 22-299 provides for the use of Nevirapine Tablets for Oral Suspension 50mg in combination with other antiretrovirals agents and is indicated for the treatment of HIV infections.

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), marketed under various brand name including Viramune by its innovator Boehringer Ingelheim.

NNRTIs stop HIV from multiplying by preventing the reverse transcriptase enzyme from working. This enzyme changes HIV’s genetic material (RNA) into the form of DNA. This step has to occur before HIV’s genetic code gets inserted into an infected cell’s genetic codes.

Nevirapine is reportedly the first NNRTI approved by US FDA. US FDA approved nevirapine for adults 1996 and for children in 1998 for children.

Nevirapine got European approval in 1997.

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, a leading APIs and generics company from India,  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, 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.