U.S. FDA classifies Aurobindo Pharma warehouse in New Jersey as Official Action Indicated, impacting compliance and ...
Subsequently, the US FDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated (OAI)'.
In the backdrop of the US-India dialogue on tariffs, the Pharmaceuticals Exports Promotion Council (Pharmexcil), Indian ...
This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.
As the market opens for a new trading day, here are some stocks that are in focus. From BHEL’s new contract to Glenmark ...
However, challenges remain. President Trump’s protectionist approach could lead to higher tariffs or stricter import rules, impacting Indian pharma exports. Stricter US FDA regulations might increase ...
Voluntary action indicated (VAI) is suggested when violations are found, but the problems do not justify further regulatory ...
Iterum Therapeutics plc (NASDAQ:ITRM), a pharmaceutical company with a market capitalization of $53.43 million, has reported a regulatory compliance issue with the Nasdaq Stock Market. According to ...
Only then can pharmaceutical manufacturers pinpoint potential compliance risks and bottlenecks ... against chikungunya approved for use in the US, after Bavarian Nordic gets the green light ...
Stocks including Wirpo, BHEL, Shriram Finance, ABB India, Rail Vikas Nigam, Glenmark Pharma, ABFRL, Ircon and more will be in ...
Stocks like Narayana Hrudayalaya, Dilip Buildcon, NRB Bearings, Rail Vikas Nigam, Borosil Renewables, Aditya Birla Fashion & ...
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