Alembic Pharma bags USFDA nod for Hypertension drug Nifedipine Extended Release
Nifedipine Extended-Release Tablets are indicated for the management of i) Vasospastic Angina ii) Chronic Stable Angina (Classical EffortAssociated Angina) and iii) Hypertension.
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg, and 90 mg.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia...
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg, and 90 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Procardia XL Extended-Release Tablets, 30 mg, 60 mg, and 90 mg, of Pfizer Inc.
Nifedipine Extended-Release Tablets are indicated for the management of i) Vasospastic Angina ii) Chronic Stable Angina (Classical EffortAssociated Angina) and iii) Hypertension.
Hypertension, also known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure. Blood is carried from the heart to all parts of the body in the vessels. Each time the heart beats, it pumps blood into the vessels. Blood pressure is created by the force of blood pushing against the walls of blood vessels (arteries) as it is pumped by the heart. The higher the pressure, the harder the heart has to pump.
Nifedipine Extended-Release Tablets USP, 30 mg, 60 mg, and 90 mg, have an estimated market size of US$ 56 million for twelve months ending Sep 2022 according to IQVIA.
Alembic has a cumulative total of 177 ANDA approvals (153 final approvals and 24 tentative approvals) from the USFDA.
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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. It is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
Products under International Generics are manufactured across its facilities in Panelav, Karkhadi, and Jarod in Gujarat. Under this vertical, the company also has R&D facilities in Vadodara (Gujarat), Hyderabad (Telangana), and New Jersey (USA).
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