The FDA has issued Indian CDMO Brassica Pharma a warning letter after inspectors found employees routinely falsified data records.
The report quoted an official as saying, “The manufacturers have been sensitised on the use of pharma-grade propylene glycol.” nIn May last year, the Drugs Controller General of India (DCGI) instructed state drug controllers to direct their state-run NABL-accredited labs to prioritise the analysis of cough syrup samples from manufacturers intended for export and to issue test reports promptly.
After Hikma initiated a recall of one batch of acetaminophen injection earlier this month, the company is extending the nationwide recall to the consumer level.
Allarity Therapeutics has received notice from the Securities and Exchange Commission that an enforcement action is pending regarding FDA meetings the biotech had surrounding the new drug application for cancer therapy dovitinib.
HLB Co. and its affiliate stocks tumbled on Friday on news that the South Korean biotech group’s highly anticipated new cancer treatment Rivoceranib failed to pass the first screening conducted by the US Food and Drug Administration (FDA).
New Delhi: France based multinational pharma company Sanofi has issued a circular in the Indian market stating that it is going to temporarily halt the sales of its Allegra Suspension syrup (Fexofenadine Hydrochloride Suspension) and Combiflam Suspension (Ibuprofen and Paracetamol Suspension).
The U.S. Food and Drug Administration has concluded its inspection of a manufacturing facility of Divi's Laboratories Ltd. in Andhra Pradesh and made one procedural observation, the company said.
As with GSK before it, Daewoong Bio’s manufacturing misstep has resulted in a ban for the Korean company from China’s bulk-buy drug procurement program.
US FDA declines to approve Orexo`s opioid overdose drug
The breadth of problems uncovered by the FDA is surprising considering the plant has been producing camrelizumab for the Chinese market since 2019.