Sidvim LifeSciences Private Limited

  Contents FDA approvals in the month of June 2021.  General information.  Nepali pharmaceutical companies mull setting up vaccine plants.  WHO's Solidarity trial will test three new potential COVID-19 drugs in a new phase .  Intellectual Property.  FCM vs Natco (and Best Crop)    FDA approvals in month of June 2021 Below are the approvals for the month of June. We covered the chemistry of Finerenone last week. We will be covering the chemistry of the remaining small molecules in this and few subsequent Newsletters.  Drug Name Active Ingredient FDA-approved use on approval date Kerendia Finerenone To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes Rezurock Belumosudil To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy fexinidazole Fexinidazole To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense Bylvay Odevixibat To treat pruritus S

  Content FDA approvals in the month of June 2021.  General information.  The U.S. Needs to Reimagine Its Pharma Supply Chain .  Almac, PILA PHARMA Enter API Manufacturing Pact   Intellectual Property.    FDA approvals in month of June 2021 Below are the approvals for the month of June. We will be covering the chemistry of small molecules in this and subsequent Newsletters. Drug Name Active Ingredient FDA-approved use on approval date Kerendia Finerenone To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes Rezurock Belumosudil To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy fexinidazole Fexinidazole To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense Bylvay Odevixibat To treat pruritus Saphnelo Anifrolumab-fnia To treat moderate-to severe systemic lupus erythematousus along with standard therapy This week let us look at chemistry of F

Content DMFs filed in the month of May 2021.  General information.  Purdue University & US Pharmacopeia Launch Pharmaceutical Industry Technology Forum ..  Bayer Sees A Golden Age For China’s Pharmaceutical Market   Intellectual Property.  Access to generic companies for product samples.    DMFs filed in the month of May 2021   In SIDVIM, we analyze DMFs filed by generic companies. This month we analysed DMFs filed in May 2021. There are about 70 DMFs filed. Glimpses of our analysis is as below:  HOLDER SUBJECT SIDVIM comments MSN LABORATORIES PRIVATE LTD AZILSARTAN KAMEDOXOMIL This is second DMF of Azilsartan by MSN. US equivalent of WO2005080384A2 family would expire in 2025, perhaps this DMF is for those who would like to launch in 2025. GLAND PHARMA LTD DIPHENHYDRAMINE HYDROCHLORIDE Old molecule, but second DMF filed in recent past. Why this old molecule is suddenly so interesting? To be investigated. MACLEODS PHARMACEUTICALS LTD RIFAPENTINE This is TB drug. This is approved in