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Strides Pharma Science Ltd’s wholly owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received USFDA approval for tetracycline hydrochloride capsules USP, 250 mg and 500 mg.
Tetracycline hydrochloride is an antibiotic used to treat various bacterial infections of the skin, intestines, respiratory tract, urinary tract, genitals and lymph nodes. In some cases, it is used when penicillin or other antibiotics cannot be used to treat serious infections such as anthrax, listeria, clostridium and actinomyces.
The product is a generic version of Achromycin V Capsules of Avet Pharmaceuticals (previously Heritage Pharmaceuticals), the company said in a statement. It will be manufactured at the company’s flagship facility in Bengaluru and marketed by Strides Pharma Inc in the US.
According to IQVIA MAT data, the US market for tetracycline hydrochloride capsules USP is about $16 million.
Strides said it has 123 cumulative abbreviated new drug application (ANDA) filings with the USFDA, of which 84 have been approved and 39 are pending approval.
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