Strides receives US FDA approval for Tetracycline Hydrochloride Capsules

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg from the United States Food & Drug Administration (US FDA). The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals Inc (previously Heritage Pharmaceuticals.

According to IQVIA MAT data, the US market for Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg is approximately US$ 16 Mn. The product will be manufactured at the company’s flagship facility at Bangalore and will be marketed by Strides Pharma Inc. in the US market.

The company has 123 cumulative ANDA filings with US FDA of which 84 ANDAs have been approved and 39 are pending approval.

Tetracycline Hydrochloride Capsule is an antibiotic used to treat many different bacterial infections of the skin, intestines, respiratory tract, urinary tract, genitals, lymph nodes, and other body systems. In some cases, tetracycline Hydrochloride Capsule is used when penicillin or another antibiotic cannot be used to treat serious infections such as Anthrax, Listeria, Clostridium, Actinomyces.