DT
PT
Subscribe To Print Edition About The Tribune Code Of Ethics Download App Advertise with us Classifieds
search-icon-img
search-icon-img
Advertisement

Alembic Pharmaceuticals gets USFDA nod for hypertension drug

New Delhi, March 8 Alembic Pharmaceuticals Limited on Wednesday announced that it has received final approval from the US health regulatory, USFDA, for its abbreviated new drug application of Prazosin Hydrochloride Capsules, which is used for treatment of hypertension. “The...
  • fb
  • twitter
  • whatsapp
  • whatsapp
Advertisement

New Delhi, March 8

Advertisement

Alembic Pharmaceuticals Limited on Wednesday announced that it has received final approval from the US health regulatory, USFDA, for its abbreviated new drug application of Prazosin Hydrochloride Capsules, which is used for treatment of hypertension.

“The approved ANDA (abbreviated new drug application) is therapeutically equivalent to the reference listed drug product (RLD), Minipress Capsules, 1 mg, 2 mg, and 5 mg, of Pfizer Inc,” the company said in a release posted on stock exchanges.

Advertisement

Prazosin Hydrochloride Capsule, it said, is indicated for the treatment of hypertension, to lower blood pressure.

Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg have an estimated market size of USD 50 million for 12 months ended December 2022, according to IQVIA.

Advertisement

Alembic has a cumulative total of 183 ANDA approvals (160 final approvals and 23 tentative approvals) from the US Food & Drug Administration (USFDA).

Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. It is one of the leaders in branded generics in India.

Advertisement
Advertisement
Advertisement
Advertisement
tlbr_img1 Home tlbr_img2 Classifieds tlbr_img3 Premium tlbr_img4 Videos tlbr_img5 E-Paper