Strides receives USFDA approval for Tetracycline Hydrochloride capsules

Strides' 39 ANDA filings pending for USFDA approval

Tetracycline Hydrochloride Capsules

Strides Pharma Science has 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 and Drug Administration (USFDA). The product is a generic version of Achromycin V Capsules, 250 mg, and 500 mg, of Avet Pharmaceuticals (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 million (approximately Rs 120 crore). The product will be manufactured at the company’s flagship plant at Bangalore and will be marketed by Strides Pharma in the US market. The company has 123 cumulative abbreviated new drug application (ANDA) filings with USFDA, 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.


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