USFDA inspection: Glenmark Pharma gets warning letter for Goa facility
Mumbai: Drugmaker Glenmark Pharma has recently announced that the US Food and Drug Administration (USFDA) has issued a warning letter to the company's Goa facility.The USFDA had inspected the facility in May 2022 and issued Official Action Indicated (OAI) status. Official Action Indicated (OAI) means regulatory and/or administrative actions will be recommended."The...
Mumbai: Drugmaker Glenmark Pharma has recently announced that the US Food and Drug Administration (USFDA) has issued a warning letter to the company's 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.
Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at firstname.lastname@example.org Contact no. 011-43720751