Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Enablex Extended-Release Tablets, 7.5 mg and 15 mg, of Allergan Pharmaceuticals. Darifenacin Extended-Release Tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Darifenacin Extended-Release Tablets, 7.5 mg and 15 mg, have an estimated market size of $64 million for twelve months ending December 2016 according to IMS. The company now has a total of 70 ANDA approvals (62 final approvals and 8 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1658.30 |
| Dr. Reddys Lab | 1218.90 |
| Cipla | 1230.95 |
| Zydus Lifesciences | 931.80 |
| Lupin | 2313.35 |
| View more.. | |
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: