Despite the stain on Cipla’s compliance record, the company leads on drug quality in India, with major concerns raised in only 3% of FDA inspections, compared to 11% generally.
The US Food and Drug Administration chastised Cipla Ltd. for good manufacturing practice problems related to inadequate contamination safeguards at its site in Vernon, Goa, India, in a 25 February warning letter.
The firm’s high efficiency particulate (HEPA) filters and air ducts were not cleaned on a routine basis, leading to cross-contamination...
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.
