API and IP Newsletter
Contents Analysis of DMF filings in August 2021. General information. Online pharmacies can be risky. Quality issues remain for Indian pharma companies: USFDA. Intellectual Property. T 2458/17 (METHOD FOR PRODUCING FLUORINATED COMPOUNDS/HONEYWELL) of 16.9.2021. Analysis of DMF filings in August 2021 We analyse DMF filings by Indian companies. This month we had looked at DMFs filed in the month of August 2021. About 45 DMFs filed in the month of August. Some of our findings are listed below. Holder Subject SIDVIM Comments MSN LIFE SCIENCES PRIVATE LTD ELAGOLIX SODIUM Elagolix Na will become generic in next couple of years but there are only four DMF filers. Must be some chemistry challenges. MSN LABORATORIES PRIVATE LTD ERTUGLIFLOZIN Few companies must be preparing for NCE-1 date in December 2021 for their ANDA filings. Gx launch looks difficult though before 2030 BIOPHORE INDIA PHARMACEUTICALS PVT LTD CLADRIBINE This was an old drug of 1998. Oral dosage form was approved in 2