The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.
High prevalence of skin disease and diabetes to boost the global revenues of the topical drug delivery market, with uptake in China and India boosting growth.
Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
Highlighting the threat of AMR, the UK government has worked with the pharma industry to develop a new antibiotics payment model based on ‘usefulness’ to the NHS.
Strides’ Puducherry, India, facility has received a warning letter from the US FDA, which the company announced will lead to deferrals for 10 pending ANDA approvals.
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
The value generated by the manufacture of medicines has doubled since 2000, with one of the smallest countries in Europe responsible for a significant proportion of the total figure.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
