Sidvim LifeSciences Private Limited

  Contents FDA approvals in March 2021.  General information.  Collaboration to encourage US adoption of continuous manufacturing .  Delhi HC Restrains Eris Lifesciences from Infringing Novartis Sacubitril, Valsartan FDC .  Intellectual Property.  Kibow Biotech Vs La Renon (Madras HC decision)    FDA approvals in March 2021   In coming weeks we will provide information about FDA approvals in March 2021. We will concentrate on small molecules and that too mainly from synthesis of small molecules. We will not cover mechanism of action and other details of the molecule.  No. Drug Name Active Ingredient FDA-approved use on approval date* 1 Zegalogue dasiglucagon To treat severe hypoglycemia 2 Ponvory ponesimod To treat patients with relapsing forms of multiple sclerosis 3 Fotivda tivozanib To treat patients with renal cell carcinoma 4 Azstarys serdexmethylphenidate and dexmethylphenidate For the treatment of Attention Deficit Hyperactivity This week we will cover synthesis of ponesimod Thi

  Contents Analysis of import-export of Arch Pharma.  General information.  5 appellate tribunals to be scrapped .  FDA Publishes Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021 .  Intellectual Property.  Analysis of import-export of Arch Pharma This week we analysed import-export of Arch Pharma and tried to find out in which molecules Arch is investing development recourses. We glanced patent database and discovered patents related to atorvastatin process filed by Arch. Hence, in addition to below molecules some work must have been done on atorvastatin. The below list is only indicative and detailed list is not published here. It could be concluded that Arch is concentrating efforts on antiretrovirals, statins and few molecules which are not sold in US. Arch is looking for high value and small volume APIs? For more details see below table. Product Name API Sidvim Comments β-Nicotinamide adenine dinucleotide phosphate hydrate Rivastigmine Not a

  Contents Analysis of import-export of MSN Pharma.  General information.  Royalty Pharma Acquires Royalty Interest in Cabozantinib From GSK .  Ascentage Pharma Announces 2020 Annual Results and Reports Launch Readiness for Its Core Drug Candidate .  Intellectual Property.   Analysis of import-export of MSN Pharma In our firm, we analyse import-export of various pharmaceutical companies. We derive very interesting information. This month we analysed import-export of MSN Pharma and tried to find out in which molecules MSN is investing development recourses. At what stage that development would be at present? Whether there are any activities going on with innovators. We gather wealth of information. Due to space constraint, we are providing here glimpses of our findings. Intermediate Qty in Kg API SIDVIM Comments 6 BROMO-3-HYDROXYPYRAZINE-2-CARBOXAMIDE - Favipiravir MSN had filed DMF. This could be the second source activity to secure supply? Multiple shipments in two months. Favipiravir