Shilpa Medicare informs about company updates

16 Nov 2018 Evaluate

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.

Shilpa Medicare Share Price

315.85 -4.50 (-1.40%)
30-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1719.60
Dr. Reddys Lab 1265.95
Cipla 1491.40
Zydus Lifesciences 901.30
Lupin 2081.00
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×