General Announcement::Glenmark Pharmaceuticals receives tentative ANDA approval for Fulvestrant Injection, 250 mg/5 mL

Issuer & Securities

Issuer/ Manager
GLENMARK PHARMACEUTICALS LIMITED
Securities
GLENMARK PH US$200M4.5%210802 - XS1456577334 - 4N4B
GLENMARK PHARM US$170M2%220628 - XS1426780125 - 4G8B
Stapled Security
No

Announcement Details

Announcement Title
General Announcement
Date &Time of Broadcast
07-Feb-2019 11:48:18
Status
New
Announcement Sub Title
Glenmark Pharmaceuticals receives tentative ANDA approval for Fulvestrant Injection, 250 mg/5 mL
Announcement Reference
SG190207OTHRH1CV
Submitted By (Co./ Ind. Name)
Glenmark Pharmaceuticals Limited
Designation
Company Secretary & Compliance Officer
Effective Date and Time of the event
07/02/2019 09:18:00
Description (Please provide a detailed description of the event in the box below)
Sub: Glenmark Pharmaceuticals receives tentative ANDA approval for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL)

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL), a generic version of FASLODEX 1 Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP.

Attachments

SGX_PR_07022019.pdf
Total size =248K