02-02-2022 11:13 AM | Source: Accord Fintech
Alembic Pharma gains on getting USFDA’s nod for Fesoterodine Fumarate Extended-Release Tablets
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Alembic Pharmaceuticals is currently trading at Rs. 770.75, up by 8.60 points or 1.13% from its previous closing of Rs. 762.15 on the BSE.

The scrip opened at Rs. 762.20 and has touched a high and low of Rs. 772.90 and Rs. 761.75 respectively. So far 1713 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1090.00 on 27-Apr-2021 and a 52 week low of Rs. 715.00 on 28-Jan-2022.

Last one week high and low of the scrip stood at Rs. 772.90 and Rs. 715.00 respectively. The current market cap of the company is Rs. 15157.97 crore.

The promoters holding in the company stood at 69.48%, while Institutions and Non-Institutions held 17.50% and 13.03% respectively.

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Toviaz Extended-Release Tablets, 4 mg and 8 mg, of Pfizer Inc. (Pfizer).

Fesoterodine Fumarate Extended-Release Tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

Fesoterodine Furnarate Extended-Release Tablets, 4 mg and 8 mg have an estimated market size of $ 225 million for twelve months ending September 2021 according to IQVIA. Alembic has received year to date (YTD) 20 approvals (14 final approvals and 6 tentative approvals) and a cumulative total of 159 ANDA approvals (137 final approvals arid 22 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.