Strides get USFDA nod for Tetracycline Hydrochloride Capsules

Bangalore: Strides Pharma Science Limited (Strides) has announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg from the United States Food & Drug Administration (USFDA). 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 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 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.

Read also: Strides Pharma arm inks pact with Pharmaceutics International to acquire 18 ANDA

Strides, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India. The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor-funded markets. The Company's global manufacturing sites are located in India- Bangalore (two locations), Pondicherry, and Chennai, Singapore, Italy- Milan, Kenya- Nairobi and United States-Florida. The Company focusses on "difficult to manufacture" products that are sold in over 100 countries. 

Medical Dialogues has previously reported Consumer healthcare firm Strides Consumer on Friday said it has forayed into North Indian market with oral nicotine replacement therapy and topical analgesic segments. 

Read also: Strides Consumer forays into North India market