A US FDA ban on Sun Pharma’s Mohali site, a legacy Ranbaxy facility, is set to be lifted, marking a significant uptick in Sun’s compliance efforts and raising hopes of momentum at the Indian firm’s other tainted facilities.
India’s top-ranked drugs firm, Sun Pharmaceutical Industries Ltd., said that the US FDA will lift a long-running import alert on its site in Mohali in the northern state of Punjab in India; the agency will also remove the facility from the Official Action Indicated (OAI) status.
“This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the...
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.
