Shilpa Medicare has informed that the Company's ANDA (210291) for Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg has been granted tentative approval by FDA. Dimethyl Fumarate Delayed Release Capsules 120 mg & 240 mg is a generic of Tecfidera, used in the treatment of patients with relapsing forms of multiple sclerosis. This ANDA is a first to file submission made on NCE-1 dated March 27, 2017. FDA review process was completed and got approval within a period of 19.5 months from the date of submission. According to IQVIA MAT Q2 2018 data, the US market for Dimethyl Fumarate DR Capsules is approximately $3.46 billion.
The above information is a part of company’s filings submitted to BSE.
| Company Name | CMP |
|---|---|
| Sun Pharma. Inds. | 1865.95 |
| Dr. Reddys Labs. | 1339.35 |
| Cipla | 1456.95 |
| Zydus Lifesciences | 1108.85 |
| Lupin | 2396.50 |
| View more.. | |
Start Research-backed Investing ...Now. Subscribe to Sapphire
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: