Aurobindo Injectables Unit Falls Foul Of FDA But Analysts Hopeful
Executive Summary
Aurobindo Pharma Ltd, India’s third-largest drug company by sales, has run into trouble with the US Food and Drug Administration, which has issued nine observations on its key sterile injectables unit in southern India, but analysts are confident there will be only a limited commercial impact.
You may also be interested in...
Signs Of Improving FDA Inspection Outcomes At Indian Sites But Long Road Ahead
Moving up the manufacturing compliance curve is still a work in progress for several Indian firms, but there appear to be some early signs that US FDA inspection outcomes, in general, may have improved.
Sun’s Key Halol Plant Flunks FDA Inspection Again
The US FDA has flagged more issues at Indian firm Sun Pharma’s largest manufacturing plant in Halol but analysts are hoping the infractions are minor and that the Indian facility will get the regulatory green light soon, ending a blacklist on the factory supplying new products to the US.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”