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Corporate Announcement
  • Security Code530549
    CompanySHILPA MEDICARE LTD.
    Exchange Received Time06/11/2019 11:12:43
    Exchange Disseminated Time06/11/2019 11:12:50
    Time Taken00:00:07
     
     
     Intimation U/R 30 Of The SEBI(LODR) Regulations- Reg.
    Ref: Stock Code: NSE: SHILPAMED/BSE-530549
     | 11/06/19 11:12    		 
     This is to inform you that the Company has received U.S Food and Drug Administration final approval for its ANDA, Erlotinib Tablets, 25 mg, 100 mg, and 150 mg on 05 Nov 2019.
    Erlotinib Tablets, 25 mg, 100 mg, and 150 mg is a generic equivalent of reference listed drug (RLD) TARCEVA used in the treatment of patients with metastatic non-small cell lung cancer (NSCLC) and locally advanced, unresectable or metastatic pancreatic cancer as recommended in the label approved by FDA.

    According to IQVIA MAT Q2 2019 data, the US market for Erlotinib Tablets is approximately US$ 172 Million.
    This is for your information and doing the needful.
    		 
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(24) 19 Apr 24|15:04 (IST)