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As On 15-Apr-2021 EOD, Market Closed
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  • Cadila gains on receiving final USFDA nod for Macitentan Tablets

    Cadila Healthcare rose 1.03% to Rs 466 after the pharma company announced that it has received final approval from the USFDA to market Macitentan Tablets, 10 mg.



    Macitentan is used to manage the symptoms of pulmonary arterial hypertension. Macitentan is in a class of medications called endothelin receptor antagonists. The drug works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have Pulmonary Arterial Hypertension.

    According to the USFDA letter, Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Macitentan Tablets, 10 mg. Therefore, with this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Macitentan Tablets, 10 mg.

    Meanwhile, Cadila also received final approval from the USFDA to market Ibrutinib Capsules. Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.

    According to the USFDA letter, Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules. Therefore, with this approval, Zydus is eligible for 180 days of generic drug exclusivity for Ibrutinib Capsules. For Ibrutinib Capsules, 140 mg, the company will have 180-days of shared generic drug exclusivity. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

    The group now has 314 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

    Cadila Healthcare is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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Flash News 15-Apr-2021
  •  ( 16:34) Wipro Q4 PAT rises 28% YoY to Rs 2972 cr  
  •  ( 15:56) Tinplate Company of India Q4 PAT up 107.04% Y-o-Y to Rs 56.15 cr  
  •  ( 15:38) 5paisa Capital raises capital of Rs 250.87 cr via preferential issue & warrants  
  •  ( 15:37) Sensex rises 259 pts, Nifty ends near 14,600  
  •  ( 15:14) Hero MotoCorp expands its digital outreach to enhance customer convinience  
  •  ( 13:43) India VIX jumps 4.22%; Asian stocks trade mixed  
  •  ( 13:42) The Nifty index hovers tad below 14,450 mark; weak market breadth  
  •  ( 13:40) Indices extends modest losses amid rising COVID-19 cases  
  •  ( 12:45) Tata Motors Q4 FY20 global wholesales up 43% Y-o-Y to 3.30 lakh units  
  •  ( 12:27) Nifty reclaims 14,400 mark  
  •  ( 12:27) Market breadth weak  
  •  ( 12:26) March 2021 WPI at 7.39%  
  •  ( 12:24) L&T Infotech appoints Anil Rander as the new CFO w.e.f Apr. 14  
  •  ( 11:46) NMDC hikes prices of Lump Ore and Fines from Apr. 14 onwards  
  •  ( 11:04) L&T bags significant deals across multiple business segments in Q4 FY21  
  •  ( 10:32) Infosys consol. Q4 PAT down 2.3% Q-o-Q to Rs 5,076 cr  
  •  ( 10:04) The SC of Queensland rules in favour of UPL arm filed by UK-based funder  
  •  ( 10:04) The SC of Queensland rules in favour of UPL subsidiary filed by UK-based funder  
  •  ( 09:48) Tata Metaliks Q4 PAT declines 2.7% YoY to Rs 74.99 cr  
  •  ( 09:29) Exide Industries makes an additional investment of Rs 39.99 cr in subsidiary  
  •  ( 09:21) Market nudges higher in early trade; breadth positive  
  •  ( 08:25) Asian stocks trading mixed  
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15 April 2021 00:00
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