Warning letter stemming from global nitrosamine investigation raises new concerns about Indian manufacturer.
Torrent Pharmaceuticals Ltd. came under fire in an 8 October US Food and Drug Administration warning letter for failing to properly validate the use of an alternate active pharmaceutical ingredient in its manufacturing process for losartan potassium tablets.
The warning letter resulted from the agency’s ongoing global investigation into potentially carcinogenic nitrosamine impurities in valsartan and other...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
