Strides Pharma gains after USFDA nod for antibiotic

Strides Pharma Science rose 1.31% to Rs 472.75 after the company said it received US drug regulator's approval for Tetracycline Hydrochloride capsules.

Strides Pharma Science on Wednesday (4 March) 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 (USFDA).

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.

The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals Inc (previously Heritage Pharmaceuticals Inc).

According to IQVIA MAT data, the US market for Tetracycline Hydrochloride capsules USP, 250 mg and 500 mg is approximately $16 million. 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 USFDA of which 84 ANDAs have beenapproved and 39 are pending approval.

Strides Pharma Science is a global pharmaceutical company. It focuses on difficult to manufacture products that are sold in over 100 countries.

On a consolidated basis, the drug maker's net profit fell 68% to Rs 93.89 crore despite a 28.5% rise in net sales to Rs 732.44 crore in Q3 December 2019 over Q3 December 2018.

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