Cadila scores FDA approval for BMS and Alvogen generics
pharmafile | July 3, 2018 | News story | Manufacturing and Production, Sales and Marketing | Adolat, Alvogen, Bristol-Myers Squibb, Cadila, FDA, Questran, generics, pharma
Cadila Healthcare has announced that it has gained FDA final approval to market nifedipine ER tablets in the strengths of 30/60/90mg.
The India-based company will manufacture nifedipine ER, a generic equivalent of Alvogen’s Adolat, at its Moraiya manufacturing facility in Gujurat, India. The drug, which is used to control blood pressure and reduce the risk of angina attacks through the relaxation of blood cells, is the latest Adalat generic along with several other predecessors to be approved in the United States.
Cadila has also received final FDA approval to market cholestyramine oral suspension. The pharmaceutical drug, which is a generic version of Bristol-Myers Squibb’s Questran, is used in conjunction with a healthy diet to reduce levels of cholesterol in the blood. Cadila will manufacture the generic at its manufacturing facility in the industrial town of Baddi in the Himalayan state of Himachal Pradesh. There are currently four other approved Questran generics on the US market.
Having received FDA approval to market Triamterene and Hydrochlorothiazide tablets on Monday, Cadila has filed over 330 ANDA’s and has received 201 approvals since it commenced filings in 2003-04. The company is increasing its presence in the US market and expects strong US revenue growth in the coming year, when it will launch an estimated 50 new products in the region.
Louis Goss
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