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Alembic Pharma share price rises 2% on USFDA approvals

The share touched a 52-week high of Rs 1,150 and a 52-week low of Rs 720.80 on December 18, 2020 and August 23, 2021, respectively

November 23, 2021 / 12:03 PM IST
 
 
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Alembic Pharmaceuticals share price rose 2 percent intraday to Rs 750.30 on November 23 after the company received two approvals from the US Food & Drug Administration (USFDA).

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dabigatran Etexilate Capsules, 150 mg, the company said in its press release.

The tentatively-approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer lngelheim.

Dabigatran Etexilate Capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVTY and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5 to 10 days. It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated, it added.

Dabigatran Etexilate Capsules, 150 mg have an estimated market size of USD 410 million for twelve months ending September 2021 according to IQVIA.

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Also, company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, company said in an another release.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RlD), Perforomist Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, of Mylan Specialty, L.P.

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies Private Limited.

Formoterol Fumarate Inhalation Solution, 20 mcg/2 ml per Unit-Dose Vial, has an estimated market size of USD 310 million for twelve months ending September 2021 according to IQVIA.

Alembic has received year to date (YTD) 14 approvals (11 final approvals and 3 tentative approvals) and a cumulative total of 153 ANDA approvals (134 final approvals and 19 tentative approvals) from USFDA, including this first inhalational ANDA approval.

At 11:41 hrs Alembic Pharmaceuticals was quoting at Rs 742.10, up Rs 6.45, or 0.88 percent on the BSE.

The share touched a 52-week high of Rs 1,150 and a 52-week low of Rs 720.80 on December 18, 2020 and August 23, 2021, respectively.

Currently, it is trading 35.47 percent below its 52-week high and 2.96 percent above its 52-week low.
Moneycontrol News
first published: Nov 23, 2021 12:03 pm

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