Sidvim LifeSciences Private Limited

  Contents Analysis of DMF filed in March 2021.  General information.  Optimus Pharma gets nod for phase 3 trials of Molnupiravir capsule .  Sandoz plans $183m boost to antibiotics production in Europe .  Intellectual Property.  Patents for Covid vaccines in India.   Analysis of DMF filed in March 2021   We analyse DMFs filed by various Indian companies in our organisation. Every quarter, the filings are published by USFDA. This week we analysed DMFs filed in the month of March 2021. There are more than 85 DMFs filed in March 2021! As expected more than 55 DMFs were filed by Indian companies. To cover all 55 DMFs in this one write-up would have been challenging and this post would have ran into several pages.  Hence, we are covering only a few DMFs this week.  HOLDER SUBJECT Sidvim Comments GLENMARK LIFE SCIENCE LTD IRON SUCROSE There are 15 other DMFs. Is Glenmark late? JUBILANT GENERICS LTD HISTAMINE DIHYDROCHLORIDE First Indian DMF. Histamine phosphate is discontinued. It was Eli Li

FDA approvals in April 2021.  General information.  FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers .  Pharma industry faces shortage of raw material   Intellectual Property.  PTAB held Sitagliptin Patent valid in IPR proceedings in the US.  FDA approvals in April 2021   No. Drug Name Active Ingredient FDA-approved use 1 Zynlonta loncastuximab tesirine-lpyl To treat certain types of relapsed or refractory large B-cell lymphoma 2 Jemperli dostarlimab-gxly To treat endometrial cancer 3 Nextstellis drospirenone and estetrol tablets To prevent pregnancy 4 Qelbree viloxazine For the treatment of attention deficit hyperactivity disorder Every month we follow FDA approvals of small molecules and post our observations/comments. Our comments in this section are more related to API synthesis and we do not provide information about mechanism of action of the drug. In this Newsletter we are covering Viloxazine. Viloxazine: 1.       The drug was first market