USFDA inspection: Glenmark Pharma gets warning letter for Goa facility

Medical Dialogues team had earlier reported that Glenmark Pharmaceuticals Inc., USA (Glenmark) and Glenmark Pharmaceuticals Limited had reached a settlement agreement with Pfizer Inc., PF Prism C.V., and PF Prism IMB B.V. for Axitinib Tablets, 1 mg and 5 mg, the generic version of their Inlyta Tablets, 1 mg and 5 mg. Axitinib is a cancer medicine. It works by blocking the action of the abnormal protein that signals cancer cells to multiply.

Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with a presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology, and oncology. The company has 10 world‐class manufacturing facilities spread across 4 continents and operations in over 80 countries. The company was listed on the Dow Jones Sustainability Index (DJSI), one of the world's most respected and widely accepted sustainability benchmarks, under the category of emerging markets (2021) for the fourth consecutive year.

Read also: Glenmark Pharma settles with Pfizer for Axitinib Tablets