Oman Pharmaceuticals has received approval for its first ANDA Neomycin Sulfate tablets from FDA in March-2010.
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Neomycin Sulfate tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae.
Neomycin is an aminoglycoside antibiotic. It is used to treat or prevent certain kinds of bacterial infections. It is also used to treat hepatic coma.
Oman Pharmaceuticals has a fully integrated manufacturing facility approved by regulatory authorities- FDA, TGA-Australia, MHRA-UK, RVO-Germany and GCC-DR.
Oman Pharmaceuticals is a multi-purpose facility having analytical equipments, systems and documentation. The qualified and skilled scientific pool maintains quality and regulatory standards as per the current good manufacturing practice.
Th ANDA approval from FDA, brings various opportunities for US companies to benefit from this approval facility for supplying generic drugs to US market.
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