Lupin gets USFDA nod for generic equivalent of Bactrim Oral Suspension
Mumbai, Baltimore: Drugmaker, Lupin Limited, has recently announced that the company has received approval for its Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL, from the United States Food and Drug Administration(USFDA), to market a generic equivalent of Bactrim Oral Suspension, 200 mg/40 mg per 5 mL, of Sun Pharmaceutical Industries, Inc.
Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/40 mg per 5 mL, is indicated for the treatment and prevention of a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections), and certain type of pneumonia (pneumocystis-type).
Sulfamethoxazole and Trimethoprim Oral Suspension USP (RLD: Bactrim) had estimated annual sales of approximately USD 19 million in the U.S. (IQVIA MAT September 2020).
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Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.