US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India for Dofetilide Capsules, 125 meg, 250 meg, and 500 meg. It is bioequivalent to the reference listed drug product (RLD), Tikosyn Capsules, 125 meg, 250 meg, and 500 meg, of Pfizer Inc. This product would be manufactured at the GPI facility located in Chantilly, Virginia, USA and is expected to be launch soon.
Granules now has a total of 45 ANDA approvals from US FDA (43 Final approvals and 2 tentative approvals).
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
| 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: